Martin Pfohl - Academia.edu (original) (raw)

Papers by Martin Pfohl

Research paper thumbnail of Initiating Basal Insulin Supported Oral Therapy (BOT) with Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control in Patients (Pts) with Type 2 Diabetes (T2DM) without Increasing Hypoglycemia Risk

Diabetes, Jun 22, 2018

Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-... more Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-300 in insulin-naïve pts with T2DM in Germany (n=1,680) and Switzerland, insufficiently controlled (A1c 7.5-10%) on oral antidiabetic drugs (OADs) in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving individualized A1c targets after 6 and 12 months, respectively. Secondary EPs include changes in A1c, fasting plasma glucose (FPG), body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=674). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main OAD treatments were metformin ± DPP-4 inhibitors (49.4%). Twelve months after initiating Gla-300 therapy, proportions of pts at target were 48.4% (A1c at individual target), 30.5% (FPG ≤110 mg/dL), and 60.3% (A1c or FPG at target), respectively. Hypoglycemia rates were low (≤0.events/patient year) and no severe (nocturnal) hypoglycemia was reported. BW remained stable. In conclusion, initiating BOT with Gla-300 allowed insulin-naïve, uncontrolled T2DM pts to reduce their A1c by 1.20% w/o increasing hypoglycemia risk, especially w/o increase in severe (nocturnal) hypoglycemia. Disclosure M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Sanofi. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH. H. Anderten: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp & Dohme Corp.. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp & Dohme Corp., Eli Lilly and Company, Boehringer Ingelheim GmbH, Pfizer Inc., AstraZeneca, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Takeda. K. Pegelow: Employee; Self; Sanofi-Aventis Deutschland GmbH. S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. J. Seufert: Speaker's Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG.

Research paper thumbnail of Switching the basal insulin to insulin glargine 300 U/ <scp>ml</scp> in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety

Diabetes, Obesity and Metabolism, Sep 24, 2021

AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI... more AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI‐supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla‐300) in adults with inadequately controlled type 2 diabetes (T2D).Materials and methodsThis was a non‐interventional, multicentre, prospective 12‐month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non‐Gla‐300 BOT regimen, after the physician had decided to switch the BI to Gla‐300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target.ResultsIn total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla‐300 treatment (FAS‐M12). The main previous BI was insulin glargine 100 U/ml (Gla‐100; 47.2%). Twelve months after switching to Gla‐300, 27.0% of FAS‐M12 participants achieved the FPG target and 44.8% their individualized HbA1c target. The greatest FPG target achievements were seen in previous Gla‐100 (29.3%), and greatest HbA1c target achievements in previous insulin detemir users (57.7%). The mean FPG decreased by −36.3 ± 51.2 mg/dl to 135.5 ± 36.9 mg/dl and mean HbA1c by −0.79 ± 1.01% to 7.45 ± 0.94%. Symptomatic and nocturnal hypoglycaemia incidence significantly decreased over 12 months of Gla‐300 treatment. Body weight remained unchanged.ConclusionsSwitching the BI to Gla‐300 in a BOT regimen improved metabolic control and treatment satisfaction in a substantial proportion of patients with T2D and inadequate target achievement within 12 months in clinical practice with a decreased risk of symptomatic and nocturnal hypoglycaemia and without weight gain.

Research paper thumbnail of Author response for "Switching the Basal Insulin to Insulin Glargine 300 U/ mL in People with Type 2 Diabetes under Basal Insulin Supported Oral Therapy – Observational Trial on Effectiveness and Safety

Research paper thumbnail of Switching to Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control after Failure of Basal-Bolus Therapy (BBT) with Other Basal Insulins (BI) in Patients (Pts) with Type 1 Diabetes (T1DM)

Diabetes, Jun 22, 2018

The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in ... more The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in Germany (n=1,662), Austria and Switzerland, who are uncontrolled (A1c 7.5-10%) on BOT with other basal insulins (BI) to Gla-300 in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving fasting plasma glucose (FPG) of ≤110 mg/dL after 6 and 12 months, respectively. Secondary EPs include changes in A1c, FPG, body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=679). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main previous BI was insulin glargine 100 U/mL (Gla-100; 49.2%), most common oral therapy was metformin ± DPP-4 inhibitors (46.4%). At 12 months, proportions of pts at their FPG and A1c targets were 27.0% and 43.2%, respectively. Percentage of pts at FPG and A1c target was max in previous Gla-100 pts (29.3%) and insulin detemir pts (55.3%), respectively. Hypoglycemia rates were low with a trend of &amp;gt;70% reduction of nocturnal hypoglycemia incidence. BW remained stable. In conclusion, switching the BI in a BOT regimen to Gla-300 allowed uncontrolled T2DM pts to reduce their A1c by 0.81% with less nocturnal hypoglycemia and minor BI dose changes. Disclosure J. Seufert: Speaker&#39;s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker&#39;s Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker&#39;s Bureau; Self; Eli Lilly and Company, Merck Sharp &amp;amp; Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker&#39;s Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker&#39;s Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH. H. Anderten: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp;amp; Dohme Corp.. Speaker&#39;s Bureau; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp;amp; Dohme Corp., Eli Lilly and Company, Boehringer Ingelheim GmbH, Pfizer Inc., AstraZeneca, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Takeda. K. Pegelow: Employee; Self; Sanofi-Aventis Deutschland GmbH. S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker&#39;s Bureau; Self; Sanofi.

Research paper thumbnail of Effectiveness and tolerability of treatment intensification to basal&ndash;bolus therapy in patients with type 2 diabetes on previous basal insulin-supported oral therapy with insulin glargine or supplementary insulin therapy with insulin glulisine: the PARTNER observational study

Vascular Health and Risk Management, Nov 1, 2015

Background: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatm... more Background: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatment needs to be continuously intensified to avoid long-term complications. In T2DM patients on either basal insulin-supported oral therapy (BOT) or supplementary insulin therapy (SIT) presenting with HbA 1c values above individual targets for 3-6 months, therapy should be intensified. This study investigated effectiveness and tolerability of an intensification of BOT or SIT to a basal-bolus therapy (BBT) regimen in T2DM patients in daily clinical practice. Methods: This noninterventional, 8-month, prospective, multicenter study evaluated parameters of glucose control, occurrence of adverse events (eg, hypoglycemia), and acceptance of devices in daily clinical practice routine after 12 and 24 weeks of intensifying insulin therapy to a BBT regimen starting from either preexisting BOT with insulin glargine (pre-BOT) or preexisting SIT with $3 daily injections of insulin glulisine (pre-SIT). Results: A total of 1,530 patients were documented in 258 German medical practices. A total of 1,301 patients were included in the full analysis set (55% male, 45% female; age median 64 years; body mass index median 30.8 kg/m 2 ; pre-BOT: n=1,072; pre-SIT: n=229), and 1,515 patients were evaluated for safety. After 12 weeks, HbA 1c decreased versus baseline (pre-BOT 8.67%; pre-SIT 8.46%) to 7.73% and 7.66%, respectively (∆ mean-0.94% and-0.80%; P,0.0001). At week 24, HbA 1c was further reduced to 7.38% and 7.30%, respectively (∆ mean-1.29% and-1.15%; P,0.0001), with a mean reduction of fasting blood glucose values in both treatment groups by more than 46 mg/dL. An HbA 1c goal of #6.5% was reached by 17.9% (pre-BOT) and 18.6% (pre-SIT), and an HbA 1c #7.0% by 46.1% (pre-BOT) and 43.0% (pre-SIT) of patients. During 24 weeks, severe as well as serious hypoglycemic events were rare (pre-BOT: n=5; pre-SIT: n=2; pretreated with both insulins: n=1). Conclusion: Intensifying glargine-based BOT or glulisine-based SIT to a BBT regimen in poorly controlled T2DM patients in daily routine care led to marked improvements of glycemic control and was well tolerated.

Research paper thumbnail of Different persistence on initial basal supported oral therapy in Type 2 diabetics is associated with unequal distributions of insulin treatment regimens under real-life conditions in Germany

International Journal of Clinical Pharmacology and Therapeutics, Nov 1, 2010

Results from a representative German database and from two German health services research studie... more Results from a representative German database and from two German health services research studies revealed an unequal distribution between basal supported oral therapy (BOT) and basal-bolus therapy (ICT) regimens in Type 2 diabetics treated with either insulin glargine (GLA) or human insulin (Neutral Protamine Hagedorn; NPH). This study assesses whether this unequal distribution could be caused by a different persistence on the initial BOT regimen. A Markov model was developed simulating the transition from BOT to ICT during a treatment course of 10 years. Data on persistence with BOT were obtained from the IMS® Disease Analyzer database. The model cohort consisted of German statutorily insured Type 2 diabetics starting a BOT either with insulin glargine or NPH insulin at a ratio of 1 : 1. The number of Type 2 diabetics who switched from BOT to ICT differed between the two groups: After 2 years, 53% of glargine-treated patients and 31% of NPH-treated patients continued the BOT. After 6.5 years, all NPH-treated patients had switched to ICT. However, complete transition to ICT of glargine-treated patients occurred 1.75 years later. In the first quarter of Year 3, the model simulation resulted in BOT : ICT ratios comparable to those found in the real-world settings for GLA- and NPH-treated patients. The simulation indicates that the persistence on the initial basal supported oral therapy is associated with the resulting BOT : ICT ratio. Therefore, the unequal distribution between BOT and ICT of Type 2 diabetics treated with either insulin glargine or NPH insulin might be caused by different persistence on the initial BOT regimen.

Research paper thumbnail of Different persistence on initial basal supported oral therapy in Type 2 diabetics is associated with unequal distributions of insulin treatment regimens under real-life conditions in Germany

International Journal of Clinical Pharmacology and Therapeutics, Nov 1, 2010

Results from a representative German database and from two German health services research studie... more Results from a representative German database and from two German health services research studies revealed an unequal distribution between basal supported oral therapy (BOT) and basal-bolus therapy (ICT) regimens in Type 2 diabetics treated with either insulin glargine (GLA) or human insulin (Neutral Protamine Hagedorn; NPH). This study assesses whether this unequal distribution could be caused by a different persistence on the initial BOT regimen. A Markov model was developed simulating the transition from BOT to ICT during a treatment course of 10 years. Data on persistence with BOT were obtained from the IMS® Disease Analyzer database. The model cohort consisted of German statutorily insured Type 2 diabetics starting a BOT either with insulin glargine or NPH insulin at a ratio of 1 : 1. The number of Type 2 diabetics who switched from BOT to ICT differed between the two groups: After 2 years, 53% of glargine-treated patients and 31% of NPH-treated patients continued the BOT. After 6.5 years, all NPH-treated patients had switched to ICT. However, complete transition to ICT of glargine-treated patients occurred 1.75 years later. In the first quarter of Year 3, the model simulation resulted in BOT : ICT ratios comparable to those found in the real-world settings for GLA- and NPH-treated patients. The simulation indicates that the persistence on the initial basal supported oral therapy is associated with the resulting BOT : ICT ratio. Therefore, the unequal distribution between BOT and ICT of Type 2 diabetics treated with either insulin glargine or NPH insulin might be caused by different persistence on the initial BOT regimen.

Research paper thumbnail of Author response for "Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin‐Naïve Patients with Type 2 Diabetes after Failure of Oral Therapy in a Real World Setting

Research paper thumbnail of Four-year evolution of insulin regimens, glycaemic control, hypoglycaemia and body weight after starting insulin therapy in type 2 diabetes across three continents

Europe PMC (PubMed Central), Sep 1, 2013

Research paper thumbnail of Hypothalamic-pituitary activation does not differ during human and porcine insulin-induced hypoglycemia in insulin-dependent diabetes mellitus

The Clinical investigator, Dec 1, 1993

Research paper thumbnail of Effectiveness and Safety of Switching Rapid-Acting Insulins to Insulin Glulisine in Patients with Diabetes: The Observational IGLU-S Study

Diabetes Therapy, 2021

The IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insul... more The IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insulin/other rapid-acting insulin analogues in patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in a real-world setting in Germany. Open-label, prospective, multicentre, non-interventional study in Germany. The primary outcome was proportion of patients reaching pre-defined glycosylated haemoglobin A1c (HbA1c) goal at 3, 6, 9 and 12 months. Secondary outcomes included absolute changes in HbA1c, rate of hypoglycaemia and 7-point blood glucose profiles. Overall, 432 (55 T1DM, 377 T2DM) patients were enrolled. Baseline HbA1c was 8.2% (T1DM) and 8.3% (T2DM); individual HbA1c targets were 6.8% and 6.9%, respectively. After insulin glulisine introduction, the proportion of patients achieving their individual HbA1c increased to 43.6% (T1DM) and 39.6% (T2DM) of patients at 12 months. At 12 months, mean HbA1c was reduced by 0.86 ± 1.03% (p < 0.0001) in T1DM and 1.01 ± 1.02 (p < 0...

Research paper thumbnail of Author response for "Switching the Basal Insulin to Insulin Glargine 300 U/ mL in People with Type 2 Diabetes under Basal Insulin Supported Oral Therapy – Observational Trial on Effectiveness and Safety

Research paper thumbnail of Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety

Diabetes, Obesity and Metabolism, 2021

AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI... more AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI‐supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla‐300) in adults with inadequately controlled type 2 diabetes (T2D).Materials and methodsThis was a non‐interventional, multicentre, prospective 12‐month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non‐Gla‐300 BOT regimen, after the physician had decided to switch the BI to Gla‐300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target.ResultsIn total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla‐300 treatment (FAS‐M12). The main previous BI was insulin glargine 100 U/ml (Gla‐100; 47.2%). Twelve months after switching to Gla‐300, 27.0% of FAS‐M12 participants achieved the FPG target and ...

Research paper thumbnail of Author response for "Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin‐Naïve Patients with Type 2 Diabetes after Failure of Oral Therapy in a Real World Setting

Research paper thumbnail of Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

Diabetes, Obesity and Metabolism, 2020

AimTo evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (B... more AimTo evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla‐300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs).Materials and MethodsThis non‐interventional, multi‐centre, prospective 52‐week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla‐300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target.ResultsOf 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla‐300 treatment. Twelve months after starting Gla‐300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by −1.22% ± 1.05% ...

Research paper thumbnail of Initiating Basal Insulin Supported Oral Therapy (BOT) with Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control in Patients (Pts) with Type 2 Diabetes (T2DM) without Increasing Hypoglycemia Risk

Diabetes, 2018

Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-... more Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-300 in insulin-naïve pts with T2DM in Germany (n=1,680) and Switzerland, insufficiently controlled (A1c 7.5-10%) on oral antidiabetic drugs (OADs) in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving individualized A1c targets after 6 and 12 months, respectively. Secondary EPs include changes in A1c, fasting plasma glucose (FPG), body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=674). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main OAD treatments were metformin ± DPP-4 inhibitors (49.4%). Twelve months after initiating Gla-300 therapy, proportions of pts at target were 48.4% (A1c at individual target), 30.5% (FPG ≤110 mg/dL), and 60.3% (A1c or FPG at target), respectively. Hypoglycemia rates were low (≤0.eve...

Research paper thumbnail of Switching to Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control and Reduces Nocturnal Hypoglycemia in Patients (Pts) with Type 2 Diabetes (T2DM) on Basal Insulin Supported Oral Therapy (BOT)

Diabetes, 2018

The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in ... more The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in Germany (n=1,662), Austria and Switzerland, who are uncontrolled (A1c 7.5-10%) on BOT with other basal insulins (BI) to Gla-300 in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving fasting plasma glucose (FPG) of ≤110 mg/dL after 6 and 12 months, respectively. Secondary EPs include changes in A1c, FPG, body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=679). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main previous BI was insulin glargine 100 U/mL (Gla-100; 49.2%), most common oral therapy was metformin ± DPP-4 inhibitors (46.4%). At 12 months, proportions of pts at their FPG and A1c targets were 27.0% and 43.2%, respectively. Percentage of pts at FPG and A1c target was max in previous Gla-100 pts (29.3%) and ...

Research paper thumbnail of Efficacy and safety of using insulin glargine in patients with type 2 diabetes on non-insulin antidiabetic therapy failing to achieve control of blood sugar: the Toujeo-1 trial

Research paper thumbnail of Titration and optimization trial for the initiation of insulin glargine 100 U/mL in patients with inadequately controlled type 2 diabetes on oral antidiabetic drugs

Diabetes, Obesity and Metabolism, 2018

For patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, addition of b... more For patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, addition of basal insulin is recommended, but titration and optimization of basal insulin therapy in primary care is not well understood. We conducted an observational trial in 2470 patients with T2DM who initiated insulin glargine 100 U/L (Gla-100) on top of oral antidiabetic drugs. Physicians were free to choose either a "Davies," "Fritsche" or "individual" titration algorithm. We found that fasting blood glucose (FBG) and glycated haemoglobin (HbA1c) levels were effectively reduced by Gla-100; 65.9% of patients achieved the primary endpoint (FBG ≤6.1 mmol/L (110 mg/dL) or an individual HbA1c target). There were no significant differences in efficacy and safety between the algorithms used. The mean FBG decreased by 3.2 mmol/L (59 mg/dL) over 12 months, while the mean HbA1c decreased by 15.3 mmol/mol (1.4%)%. From a starting dose of 11.7 U/d, the Gla-100 dosage was 22.8 U/d at 12 months, with similar values in each group. Rates of hypoglycaemia were low and did not differ by titration algorithm. We conclude that Gla-100 was effective at reducing FBG and HbA1c, independent of the titration algorithm, but observed that algorithms were inconsistently applied in clinical practice. K E Y W O R D S basal, basal insulin-supported oral therapy, hypoglycaemia, insulin glargine, titration algorithm 1 | INTRODUCTION In type 2 diabetes mellitus (T2DM), oral antidiabetic drugs (OADs) provide effective blood glucose-lowering in the early stages of the condition, but treatment intensification with insulin is frequently required over time. 1 An initial dose of 10 U/d or 0.1 to 0.2 U/kg/d basal insulin is advocated in guidelines. 2 Titration is guided by fasting blood glucose (FBG) measurements until a stable level of 5.0 to 7.2 mmol/L ([70]90-130 mg/dL) is achieved. At present, no specific starting dose or titration algorithm for insulin initiation in patients with T2DM is advocated in German guidelines. 3 The joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes provides recommendations for the starting dose, but the proposed titration approach lacks detail. 2,4 An observational trial was therefore established to analyse which algorithms were most commonly used for titrating insulin glargine in patients with T2DM and inadequate glycaemic

Research paper thumbnail of Patienten mit unzureichend kontrolliertem Typ-2 Diabetes mellitus unter oralen Antidiabetika: Einfluss des Alters auf die Insulin Glargin U100-Titration in der hausärztlichen Praxis

Diabetologie und Stoffwechsel, 2017

Research paper thumbnail of Initiating Basal Insulin Supported Oral Therapy (BOT) with Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control in Patients (Pts) with Type 2 Diabetes (T2DM) without Increasing Hypoglycemia Risk

Diabetes, Jun 22, 2018

Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-... more Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-300 in insulin-naïve pts with T2DM in Germany (n=1,680) and Switzerland, insufficiently controlled (A1c 7.5-10%) on oral antidiabetic drugs (OADs) in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving individualized A1c targets after 6 and 12 months, respectively. Secondary EPs include changes in A1c, fasting plasma glucose (FPG), body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=674). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main OAD treatments were metformin ± DPP-4 inhibitors (49.4%). Twelve months after initiating Gla-300 therapy, proportions of pts at target were 48.4% (A1c at individual target), 30.5% (FPG ≤110 mg/dL), and 60.3% (A1c or FPG at target), respectively. Hypoglycemia rates were low (≤0.events/patient year) and no severe (nocturnal) hypoglycemia was reported. BW remained stable. In conclusion, initiating BOT with Gla-300 allowed insulin-naïve, uncontrolled T2DM pts to reduce their A1c by 1.20% w/o increasing hypoglycemia risk, especially w/o increase in severe (nocturnal) hypoglycemia. Disclosure M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker&#39;s Bureau; Self; Sanofi. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH. H. Anderten: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp;amp; Dohme Corp.. Speaker&#39;s Bureau; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp;amp; Dohme Corp., Eli Lilly and Company, Boehringer Ingelheim GmbH, Pfizer Inc., AstraZeneca, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Takeda. K. Pegelow: Employee; Self; Sanofi-Aventis Deutschland GmbH. S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. J. Seufert: Speaker&#39;s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker&#39;s Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker&#39;s Bureau; Self; Eli Lilly and Company, Merck Sharp &amp;amp; Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker&#39;s Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker&#39;s Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG.

Research paper thumbnail of Switching the basal insulin to insulin glargine 300 U/ <scp>ml</scp> in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety

Diabetes, Obesity and Metabolism, Sep 24, 2021

AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI... more AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI‐supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla‐300) in adults with inadequately controlled type 2 diabetes (T2D).Materials and methodsThis was a non‐interventional, multicentre, prospective 12‐month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non‐Gla‐300 BOT regimen, after the physician had decided to switch the BI to Gla‐300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target.ResultsIn total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla‐300 treatment (FAS‐M12). The main previous BI was insulin glargine 100 U/ml (Gla‐100; 47.2%). Twelve months after switching to Gla‐300, 27.0% of FAS‐M12 participants achieved the FPG target and 44.8% their individualized HbA1c target. The greatest FPG target achievements were seen in previous Gla‐100 (29.3%), and greatest HbA1c target achievements in previous insulin detemir users (57.7%). The mean FPG decreased by −36.3 ± 51.2 mg/dl to 135.5 ± 36.9 mg/dl and mean HbA1c by −0.79 ± 1.01% to 7.45 ± 0.94%. Symptomatic and nocturnal hypoglycaemia incidence significantly decreased over 12 months of Gla‐300 treatment. Body weight remained unchanged.ConclusionsSwitching the BI to Gla‐300 in a BOT regimen improved metabolic control and treatment satisfaction in a substantial proportion of patients with T2D and inadequate target achievement within 12 months in clinical practice with a decreased risk of symptomatic and nocturnal hypoglycaemia and without weight gain.

Research paper thumbnail of Author response for "Switching the Basal Insulin to Insulin Glargine 300 U/ mL in People with Type 2 Diabetes under Basal Insulin Supported Oral Therapy – Observational Trial on Effectiveness and Safety

Research paper thumbnail of Switching to Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control after Failure of Basal-Bolus Therapy (BBT) with Other Basal Insulins (BI) in Patients (Pts) with Type 1 Diabetes (T1DM)

Diabetes, Jun 22, 2018

The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in ... more The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in Germany (n=1,662), Austria and Switzerland, who are uncontrolled (A1c 7.5-10%) on BOT with other basal insulins (BI) to Gla-300 in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving fasting plasma glucose (FPG) of ≤110 mg/dL after 6 and 12 months, respectively. Secondary EPs include changes in A1c, FPG, body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=679). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main previous BI was insulin glargine 100 U/mL (Gla-100; 49.2%), most common oral therapy was metformin ± DPP-4 inhibitors (46.4%). At 12 months, proportions of pts at their FPG and A1c targets were 27.0% and 43.2%, respectively. Percentage of pts at FPG and A1c target was max in previous Gla-100 pts (29.3%) and insulin detemir pts (55.3%), respectively. Hypoglycemia rates were low with a trend of &amp;gt;70% reduction of nocturnal hypoglycemia incidence. BW remained stable. In conclusion, switching the BI in a BOT regimen to Gla-300 allowed uncontrolled T2DM pts to reduce their A1c by 0.81% with less nocturnal hypoglycemia and minor BI dose changes. Disclosure J. Seufert: Speaker&#39;s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker&#39;s Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker&#39;s Bureau; Self; Eli Lilly and Company, Merck Sharp &amp;amp; Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker&#39;s Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker&#39;s Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH. H. Anderten: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp;amp; Dohme Corp.. Speaker&#39;s Bureau; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp;amp; Dohme Corp., Eli Lilly and Company, Boehringer Ingelheim GmbH, Pfizer Inc., AstraZeneca, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Takeda. K. Pegelow: Employee; Self; Sanofi-Aventis Deutschland GmbH. S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker&#39;s Bureau; Self; Sanofi.

Research paper thumbnail of Effectiveness and tolerability of treatment intensification to basal&ndash;bolus therapy in patients with type 2 diabetes on previous basal insulin-supported oral therapy with insulin glargine or supplementary insulin therapy with insulin glulisine: the PARTNER observational study

Vascular Health and Risk Management, Nov 1, 2015

Background: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatm... more Background: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatment needs to be continuously intensified to avoid long-term complications. In T2DM patients on either basal insulin-supported oral therapy (BOT) or supplementary insulin therapy (SIT) presenting with HbA 1c values above individual targets for 3-6 months, therapy should be intensified. This study investigated effectiveness and tolerability of an intensification of BOT or SIT to a basal-bolus therapy (BBT) regimen in T2DM patients in daily clinical practice. Methods: This noninterventional, 8-month, prospective, multicenter study evaluated parameters of glucose control, occurrence of adverse events (eg, hypoglycemia), and acceptance of devices in daily clinical practice routine after 12 and 24 weeks of intensifying insulin therapy to a BBT regimen starting from either preexisting BOT with insulin glargine (pre-BOT) or preexisting SIT with $3 daily injections of insulin glulisine (pre-SIT). Results: A total of 1,530 patients were documented in 258 German medical practices. A total of 1,301 patients were included in the full analysis set (55% male, 45% female; age median 64 years; body mass index median 30.8 kg/m 2 ; pre-BOT: n=1,072; pre-SIT: n=229), and 1,515 patients were evaluated for safety. After 12 weeks, HbA 1c decreased versus baseline (pre-BOT 8.67%; pre-SIT 8.46%) to 7.73% and 7.66%, respectively (∆ mean-0.94% and-0.80%; P,0.0001). At week 24, HbA 1c was further reduced to 7.38% and 7.30%, respectively (∆ mean-1.29% and-1.15%; P,0.0001), with a mean reduction of fasting blood glucose values in both treatment groups by more than 46 mg/dL. An HbA 1c goal of #6.5% was reached by 17.9% (pre-BOT) and 18.6% (pre-SIT), and an HbA 1c #7.0% by 46.1% (pre-BOT) and 43.0% (pre-SIT) of patients. During 24 weeks, severe as well as serious hypoglycemic events were rare (pre-BOT: n=5; pre-SIT: n=2; pretreated with both insulins: n=1). Conclusion: Intensifying glargine-based BOT or glulisine-based SIT to a BBT regimen in poorly controlled T2DM patients in daily routine care led to marked improvements of glycemic control and was well tolerated.

Research paper thumbnail of Different persistence on initial basal supported oral therapy in Type 2 diabetics is associated with unequal distributions of insulin treatment regimens under real-life conditions in Germany

International Journal of Clinical Pharmacology and Therapeutics, Nov 1, 2010

Results from a representative German database and from two German health services research studie... more Results from a representative German database and from two German health services research studies revealed an unequal distribution between basal supported oral therapy (BOT) and basal-bolus therapy (ICT) regimens in Type 2 diabetics treated with either insulin glargine (GLA) or human insulin (Neutral Protamine Hagedorn; NPH). This study assesses whether this unequal distribution could be caused by a different persistence on the initial BOT regimen. A Markov model was developed simulating the transition from BOT to ICT during a treatment course of 10 years. Data on persistence with BOT were obtained from the IMS® Disease Analyzer database. The model cohort consisted of German statutorily insured Type 2 diabetics starting a BOT either with insulin glargine or NPH insulin at a ratio of 1 : 1. The number of Type 2 diabetics who switched from BOT to ICT differed between the two groups: After 2 years, 53% of glargine-treated patients and 31% of NPH-treated patients continued the BOT. After 6.5 years, all NPH-treated patients had switched to ICT. However, complete transition to ICT of glargine-treated patients occurred 1.75 years later. In the first quarter of Year 3, the model simulation resulted in BOT : ICT ratios comparable to those found in the real-world settings for GLA- and NPH-treated patients. The simulation indicates that the persistence on the initial basal supported oral therapy is associated with the resulting BOT : ICT ratio. Therefore, the unequal distribution between BOT and ICT of Type 2 diabetics treated with either insulin glargine or NPH insulin might be caused by different persistence on the initial BOT regimen.

Research paper thumbnail of Different persistence on initial basal supported oral therapy in Type 2 diabetics is associated with unequal distributions of insulin treatment regimens under real-life conditions in Germany

International Journal of Clinical Pharmacology and Therapeutics, Nov 1, 2010

Results from a representative German database and from two German health services research studie... more Results from a representative German database and from two German health services research studies revealed an unequal distribution between basal supported oral therapy (BOT) and basal-bolus therapy (ICT) regimens in Type 2 diabetics treated with either insulin glargine (GLA) or human insulin (Neutral Protamine Hagedorn; NPH). This study assesses whether this unequal distribution could be caused by a different persistence on the initial BOT regimen. A Markov model was developed simulating the transition from BOT to ICT during a treatment course of 10 years. Data on persistence with BOT were obtained from the IMS® Disease Analyzer database. The model cohort consisted of German statutorily insured Type 2 diabetics starting a BOT either with insulin glargine or NPH insulin at a ratio of 1 : 1. The number of Type 2 diabetics who switched from BOT to ICT differed between the two groups: After 2 years, 53% of glargine-treated patients and 31% of NPH-treated patients continued the BOT. After 6.5 years, all NPH-treated patients had switched to ICT. However, complete transition to ICT of glargine-treated patients occurred 1.75 years later. In the first quarter of Year 3, the model simulation resulted in BOT : ICT ratios comparable to those found in the real-world settings for GLA- and NPH-treated patients. The simulation indicates that the persistence on the initial basal supported oral therapy is associated with the resulting BOT : ICT ratio. Therefore, the unequal distribution between BOT and ICT of Type 2 diabetics treated with either insulin glargine or NPH insulin might be caused by different persistence on the initial BOT regimen.

Research paper thumbnail of Author response for "Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin‐Naïve Patients with Type 2 Diabetes after Failure of Oral Therapy in a Real World Setting

Research paper thumbnail of Four-year evolution of insulin regimens, glycaemic control, hypoglycaemia and body weight after starting insulin therapy in type 2 diabetes across three continents

Europe PMC (PubMed Central), Sep 1, 2013

Research paper thumbnail of Hypothalamic-pituitary activation does not differ during human and porcine insulin-induced hypoglycemia in insulin-dependent diabetes mellitus

The Clinical investigator, Dec 1, 1993

Research paper thumbnail of Effectiveness and Safety of Switching Rapid-Acting Insulins to Insulin Glulisine in Patients with Diabetes: The Observational IGLU-S Study

Diabetes Therapy, 2021

The IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insul... more The IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insulin/other rapid-acting insulin analogues in patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in a real-world setting in Germany. Open-label, prospective, multicentre, non-interventional study in Germany. The primary outcome was proportion of patients reaching pre-defined glycosylated haemoglobin A1c (HbA1c) goal at 3, 6, 9 and 12 months. Secondary outcomes included absolute changes in HbA1c, rate of hypoglycaemia and 7-point blood glucose profiles. Overall, 432 (55 T1DM, 377 T2DM) patients were enrolled. Baseline HbA1c was 8.2% (T1DM) and 8.3% (T2DM); individual HbA1c targets were 6.8% and 6.9%, respectively. After insulin glulisine introduction, the proportion of patients achieving their individual HbA1c increased to 43.6% (T1DM) and 39.6% (T2DM) of patients at 12 months. At 12 months, mean HbA1c was reduced by 0.86 ± 1.03% (p < 0.0001) in T1DM and 1.01 ± 1.02 (p < 0...

Research paper thumbnail of Author response for "Switching the Basal Insulin to Insulin Glargine 300 U/ mL in People with Type 2 Diabetes under Basal Insulin Supported Oral Therapy – Observational Trial on Effectiveness and Safety

Research paper thumbnail of Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety

Diabetes, Obesity and Metabolism, 2021

AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI... more AimsThis study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI‐supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla‐300) in adults with inadequately controlled type 2 diabetes (T2D).Materials and methodsThis was a non‐interventional, multicentre, prospective 12‐month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non‐Gla‐300 BOT regimen, after the physician had decided to switch the BI to Gla‐300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target.ResultsIn total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla‐300 treatment (FAS‐M12). The main previous BI was insulin glargine 100 U/ml (Gla‐100; 47.2%). Twelve months after switching to Gla‐300, 27.0% of FAS‐M12 participants achieved the FPG target and ...

Research paper thumbnail of Author response for "Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin‐Naïve Patients with Type 2 Diabetes after Failure of Oral Therapy in a Real World Setting

Research paper thumbnail of Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

Diabetes, Obesity and Metabolism, 2020

AimTo evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (B... more AimTo evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla‐300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs).Materials and MethodsThis non‐interventional, multi‐centre, prospective 52‐week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla‐300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target.ResultsOf 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla‐300 treatment. Twelve months after starting Gla‐300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by −1.22% ± 1.05% ...

Research paper thumbnail of Initiating Basal Insulin Supported Oral Therapy (BOT) with Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control in Patients (Pts) with Type 2 Diabetes (T2DM) without Increasing Hypoglycemia Risk

Diabetes, 2018

Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-... more Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-300 in insulin-naïve pts with T2DM in Germany (n=1,680) and Switzerland, insufficiently controlled (A1c 7.5-10%) on oral antidiabetic drugs (OADs) in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving individualized A1c targets after 6 and 12 months, respectively. Secondary EPs include changes in A1c, fasting plasma glucose (FPG), body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=674). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main OAD treatments were metformin ± DPP-4 inhibitors (49.4%). Twelve months after initiating Gla-300 therapy, proportions of pts at target were 48.4% (A1c at individual target), 30.5% (FPG ≤110 mg/dL), and 60.3% (A1c or FPG at target), respectively. Hypoglycemia rates were low (≤0.eve...

Research paper thumbnail of Switching to Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control and Reduces Nocturnal Hypoglycemia in Patients (Pts) with Type 2 Diabetes (T2DM) on Basal Insulin Supported Oral Therapy (BOT)

Diabetes, 2018

The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in ... more The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in Germany (n=1,662), Austria and Switzerland, who are uncontrolled (A1c 7.5-10%) on BOT with other basal insulins (BI) to Gla-300 in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving fasting plasma glucose (FPG) of ≤110 mg/dL after 6 and 12 months, respectively. Secondary EPs include changes in A1c, FPG, body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=679). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main previous BI was insulin glargine 100 U/mL (Gla-100; 49.2%), most common oral therapy was metformin ± DPP-4 inhibitors (46.4%). At 12 months, proportions of pts at their FPG and A1c targets were 27.0% and 43.2%, respectively. Percentage of pts at FPG and A1c target was max in previous Gla-100 pts (29.3%) and ...

Research paper thumbnail of Efficacy and safety of using insulin glargine in patients with type 2 diabetes on non-insulin antidiabetic therapy failing to achieve control of blood sugar: the Toujeo-1 trial

Research paper thumbnail of Titration and optimization trial for the initiation of insulin glargine 100 U/mL in patients with inadequately controlled type 2 diabetes on oral antidiabetic drugs

Diabetes, Obesity and Metabolism, 2018

For patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, addition of b... more For patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, addition of basal insulin is recommended, but titration and optimization of basal insulin therapy in primary care is not well understood. We conducted an observational trial in 2470 patients with T2DM who initiated insulin glargine 100 U/L (Gla-100) on top of oral antidiabetic drugs. Physicians were free to choose either a "Davies," "Fritsche" or "individual" titration algorithm. We found that fasting blood glucose (FBG) and glycated haemoglobin (HbA1c) levels were effectively reduced by Gla-100; 65.9% of patients achieved the primary endpoint (FBG ≤6.1 mmol/L (110 mg/dL) or an individual HbA1c target). There were no significant differences in efficacy and safety between the algorithms used. The mean FBG decreased by 3.2 mmol/L (59 mg/dL) over 12 months, while the mean HbA1c decreased by 15.3 mmol/mol (1.4%)%. From a starting dose of 11.7 U/d, the Gla-100 dosage was 22.8 U/d at 12 months, with similar values in each group. Rates of hypoglycaemia were low and did not differ by titration algorithm. We conclude that Gla-100 was effective at reducing FBG and HbA1c, independent of the titration algorithm, but observed that algorithms were inconsistently applied in clinical practice. K E Y W O R D S basal, basal insulin-supported oral therapy, hypoglycaemia, insulin glargine, titration algorithm 1 | INTRODUCTION In type 2 diabetes mellitus (T2DM), oral antidiabetic drugs (OADs) provide effective blood glucose-lowering in the early stages of the condition, but treatment intensification with insulin is frequently required over time. 1 An initial dose of 10 U/d or 0.1 to 0.2 U/kg/d basal insulin is advocated in guidelines. 2 Titration is guided by fasting blood glucose (FBG) measurements until a stable level of 5.0 to 7.2 mmol/L ([70]90-130 mg/dL) is achieved. At present, no specific starting dose or titration algorithm for insulin initiation in patients with T2DM is advocated in German guidelines. 3 The joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes provides recommendations for the starting dose, but the proposed titration approach lacks detail. 2,4 An observational trial was therefore established to analyse which algorithms were most commonly used for titrating insulin glargine in patients with T2DM and inadequate glycaemic

Research paper thumbnail of Patienten mit unzureichend kontrolliertem Typ-2 Diabetes mellitus unter oralen Antidiabetika: Einfluss des Alters auf die Insulin Glargin U100-Titration in der hausärztlichen Praxis

Diabetologie und Stoffwechsel, 2017