Effectiveness and Safety of Insulin Glulisine When Initiating Supplementary Prandial Insulin Treatment (SIT) in Insulin-Naïve Patients with Type 2 Diabetes: The Observational IGLU-SIT Study (original) (raw)
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Diabetes, Obesity and Metabolism, 2011
Stepwise intensification of insulin treatment to match the progressive decline of endogenous insulin secretion has been shown to be an effective management strategy in type 2 diabetes mellitus (T2DM). The efficacy of initiating and titrating a single bolus dose of insulin glulisine to baseline insulin glargine plus oral hypoglycaemic agents (OHAs) was investigated. Methods: This was a 6-month, parallel-group, randomized, open-label, Phase IV study conducted in the US, UK and Russia. People with T2DM (HbA 1c 7.5-9.5%) using any basal insulin underwent a 3-month run-in period on insulin glargine titrated to optimize fasting blood glucose (BG) control. Those with HbA 1c >7.0% were randomized to either continue prior therapy (n = 57) or to add a single dose of insulin glulisine (n = 49) immediately prior to the main meal for a further 3 months. Two different titration algorithms were employed for the bolus dose, targeting 2-h postprandial BG ≤135 mg/dL (≤7.5 mmol/l; Russia and UK) or pre-meal/bedtime BG 100-120 mg/dl (5.5-6.7 mmol/l; US). Results: HbA 1c and fasting plasma glucose levels decreased during the run-in period. In the 3 months after randomization, more participants in the basal-plus-bolus group reached HbA 1c <7.0% than the basal-only control group (22.4 vs. 8.8%; p < 0.05), with significantly greater reduction of HbA 1c (−0.37 vs. −0.11%; p = 0.0290). Rates of hypoglycaemia and mean weight change were comparable between the treatment groups. Conclusions: In people with T2DM inadequately controlled on basal insulin plus OHAs, adding a single injection of insulin glulisine prior to the main meal significantly improves glucose control without undesired side effects.
Vascular Health and Risk Management, 2015
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.
Insulin Therapy in Patients with Type 2 Diabetes Mellitus
Disease Management and Health Outcomes, 2001
Objective: To support policy-making for patients with diabetes mellitus we compared the costs and effectiveness of initiation of insulin therapy in patients with type 2 diabetes mellitus in 2 settings in The Netherlands. Design: Retrospective cohort study. Setting: A shared-care setting and an outpatient care setting of a university hospital. Both settings are located in Amsterdam, The Netherlands. Patients: All patients with type 2 diabetes mellitus above 40 years of age who were transferred to insulin therapy in 1993 in both settings. Intervention: Initiation and monitoring of insulin therapy in patients with type 2 diabetes mellitus. Study perspective: healthcare sector. Main outcome measures: Baseline and 12 months glycosylated hemoglobin (HbA1c) values and fasting blood glucose levels, and direct healthcare costs of insulin therapy. Costs were expressed in 1996 Dutch guilders (NLG) [NLG1 = 0.5 US dollars ($US)]. Results: In the shared-care setting (n = 57) the per patient healthcare costs during 1 year of follow-up averaged NLG2467. In the secondary care setting (n = 45) healthcare costs averaged NLG2740. A sensitivity analysis demonstrated that healthcare costs per patient were in the same range in both settings, ranging from NLG2000 to about NLG3400 ($US1000 to $US1700). Mean HbA1c values fell from 9.1 to 7.9% (shared-care setting; p < 0.05) and from 10.2 to 8.2% (secondary care setting; p < 0.05). The percentage of patients with poor glycemic control (HbA1c >8.5%) decreased from 56 to 30% (shared-care setting) and from 76 to 36% (secondary care setting). The percentage of patients with good glycemic
Diabetes Therapy, 2021
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...
Vascular Health and Risk Management, 2015
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.
Diabetes, Obesity and Metabolism
Funding information This study and underlying studies were funded by Sanofi. Aims: To identify factors associated with achievement of glycated haemoglobin A1c (HbA1c) target at 24 weeks after commencing basal insulin therapy in individuals with type 2 diabetes mellitus (T2DM). Materials and methods: Post-hoc pooled analysis of 16 randomized, treat-to-target trials involving individuals with T2DM inadequately controlled with oral anti-hyperglycaemic drugs (n = 3415) initiated on once-daily insulin glargine 100 U/mL (Gla-100). Clinical outcomes were assessed by HbA1c response at 24 weeks and individuals were classified as "good responders" with HbA1c <7.0% (<53 mmol/mol) or as "poor responders" with HbA1c ≥7.0% (≥53 mmol/ mol). Univariable and multivariable stepwise logistic regression analyses were performed to identify predictive factors for attaining HbA1c <7.0%. Results: Lower levels of baseline HbA1c, fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG), higher body mass index (BMI), shorter diabetes duration and male sex were associated with a good glycaemic response, but not age or baseline C-peptide levels. Gla-100 dose (U/kg) was highest in the poor-responder group, which had the fewest hypoglycaemia episodes. Univariable analysis for achievement of HbA1c <7.0% confirmed these observations. Multivariable analysis retained baseline HbA1c, body weight, BMI, sex, 2-hours PPG and diabetes duration as predictors of a good response. Continued use of sulfonylureas, hypoglycaemia and change in body weight were indicative of poor response. Conclusions: Baseline HbA1c was the strongest determinant for achieving target HbA1c <7.0% by supplementary Gla-100 therapy, while sex and BMI were also useful indicators. However, age and C-peptide levels at baseline did not predict glycaemic response to the introduction of basal insulin.
2019
Type 2 Diabetes Mellitus (T2DM) has emerged as a major global health problem and is one of the most common chronic diseases worldwide. The prevalence of T2DM in Kingdom of Saudi Arabia (KSA) population is high (23%) and has increased by 10% in just one decade. Usually addition of basal insulin is considered as the simplest way to start insulin therapy in patients uncontrolled on oral antidiabetic agents (OADs). In KSA, the majority of patients(60%) recommended to use insulin are treated with premixed insulin.Currently there is limited availability of local (KSA) data documenting the switch from premixed insulin to a basal insulin (Plus/Bolus) regimen. To monitor the effectiveness and tolerability of basal (Plus/Bolus) using Insulin glargine and Insuline glulisine in T2DM patients switched from premixed insulin for achieving the glycemic goal (Glycatedhaemoglobin-HbA1c) as targeted by the treating physician. Multicenter, non-interventional prospective product registry was conducted nationwide across KSA. Males and females aged ≥ 21 years, with type 2 diabetes mellitus, uncontrolled on premixed insulin with HbA1C>7 % and Fasting Blood Sugar >120 mg/dL were selected for this study. Changes in HbA1C from baseline to the end of 6 months and the mean number of hypoglycemic episodes experienced by each patient were measured. Out of 619 enrolled patients, 543 patients completed all study visits. There was statistically significant mean change in HbA1c (2.02%) at visit 3 as compared to baseline. Forty-three percent reduction in hypoglycemia incidence (number of patients experiencing at least one hypoglycemic event) and a 30% reduction in event rate from base line till end of 6 months was also seen in this study. In everyday clinical practice, patients with type 2 diabetes inadequately controlled on premixed insulins experienced significant improvements in glycemic control over 24 weeks after switching to a glargine-based insulin regimen. There was also a significantly lower risk of hypoglycemia and a favorable tolerability profile with this regimen. These findings support the use of a basal-bolus glarginebased regimen in T2DM patients poorly controlled on premixed insulins in KSA.
Considerations on blood glucose management in Type 2 diabetes mellitus
Diabetes/Metabolism Research and Reviews, 2002
In recent years the benefits of more intensive management in preventing or delaying the development and progression of diabetic complications have been well documented. What is not as well documented is how to motivate the person with diabetes to manage the condition, how to set, assess and quantify glucose goals, and the glucose variables that should be routinely measured. This review discusses the importance of setting targets and communicating them in a way that the patient understands. When aiming for a glycaemia target, balance is required (1) between achieving reduction of complications and causing an increased degree of hypoglycaemia, and (2) between what is achievable and what degree of benefit is gained. Target values given in guidelines should be adapted by the clinician to take into account the patient's susceptibility to hypoglycaemia, stage and type of complications, age and life expectancy, co-morbidity, social environment, understanding of the steps required and level of commitment to the treatment. Several suggestions are given regarding possible improvements and amendments to existing guidelines for diabetes management in treating to glucose goal. For example, attention should be drawn to the need to individualise goals and to consider education, long-term support, patient needs and treatment outcome when formulating diabetes management plans. The relative properties of the different glucose variables-fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated haemoglobin A 1c (HbA 1c), and glycated protein-in terms of their convenience of measurement, usefulness and relevance to the physician and patient are also evaluated. When prioritising the variables to be measured it is suggested that where feasible, HbA 1c should be the standard measurement by which to gauge risk and treatment efficacy. Serial measurements should be made and, where possible, the use of blood glucose meters encouraged, in order to obtain a blood glucose profile for the patient.
We aimed to compare the effectiveness of Glargine plus Glulisine to premixed insulin analogue, as measured by HbA1c ≤ 7.0% in insulin naive Type 2 Diabetes (T2D) patients with elevated fasting and/or postprandial plasma glucose. Methods: Insulin-naive T2D patients (116 men, 84 women) on ≥ 2 oral hypoglycemic agents with inadequate glycemic control were randomized either to group 1 (insulin Glargine plus Glulisine, n = 101) or group 2 (Premixed Insulin analogue, n = 99). Results: In the intention to treat analysis, at week 24, percentage of patients with good glycaemic control (HbA1c ≤ 7.0%) was similar between the two groups (16.8% in Group 1 vs. 13.1% in Group 2, χ2-0.535, p = 0.47). Significant reductions in fasting and postprandial levels were observed in groups 1 and 2 at both post-baseline time points (Week 12 and 24). In group 1, reduction in HbA1c from baseline to week 12 was 0.6 ± 0.1 and 0.7 ± 0.2 at week 24, p < 0.0001 for all. In group 2, no significant change in HbA1c was observed. In group 1, 83.2% required an additional dose of glulisine and in group 2, 88.9% required an additional dose of premixed insulin. Hypoglycemic events were similar in both groups (0.12 events per person-year in group 1 and 0.13 events per person-year in group 2). Weight gain was non-significant in both groups. Conclusions: Glargine plus Glulisine, though in higher dose was effective as premixed insulin in lowering HbA1c. Hypoglycemic events per person-year were similar in both groups.