GOAL study: clinical and non-clinical predictive factors for achieving glycemic control in people with type 2 diabetes in real clinical practice (original) (raw)
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Diabetes/Metabolism Research and Reviews, 2016
Background This study used data from different sources to identify the extent of the unmet need for postprandial glycemic control in patients with type 2 diabetes mellitus (T2DM) after the initiation of basal insulin therapy in Europe, Asia Pacific, the United States, and Latin America. Methods Different levels of evidence were used as available for each country/region, with data extracted from seven randomized controlled trials (RCTs), three clinical trial registries (CTRs), and three electronic medical record (EMR) databases. Glycemic status was categorized as "well controlled" (glycated hemoglobin [HbA 1c ] at target [<7%]), "residual hyperglycemia" (fasting plasma glucose [FPG] but not HbA 1c at target [FPG <7.2/7.8 mmol/L, <130/140 mg/ dL, depending on country-specific recommendations]), or "uncontrolled" (both FPG and HbA 1c above target). Predictor factors were identified from the RCT data set using logistic regression analysis. Results RCT data showed that 16.9% to 28.0%, 42.7% to 54.4%, and 16.9% to 38.1% of patients with T2DM had well-controlled glycemia, residual hyperglycemia, and uncontrolled hyperglycemia, respectively. In CTRs, respective ranges were 21.8% to 33.6%, 31.5% to 35.6%, and 30.7% to 46.8%, and in EMR databases were 4.4% to 21.0%, 23.9% to 31.8%, and 53.6% to 63.8%. Significant predictor factors of residual hyperglycemia identified from RCT data included high baseline HbA 1c (all countries/regions except Brazil), high baseline FPG (United Kingdom/Japan), longer duration of diabetes (Brazil), and female sex (Europe/ Latin America). Conclusions Irrespective of intrinsic differences between data sources, 24% to 54% of patients with T2DM globally had residual hyperglycemia with HbA 1c not at target, despite achieving FPG control, indicating a significant unmet need for postprandial glycemic control. KEYWORDS fasting plasma glucose, glycemic control, insulin therapy, postprandial glucose, residual hyperglycemia, type 2 diabetes mellitus This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
Type 2 diabetes mellitus (T2DM) is prevalent in the Middle East and North Africa as a consequence of increasing aging populations, rapid urbanization, lack of physical exercise, and obesity. Our study objective is to explore glycemic outcomes in people with T2DM patients who initiated basal insulin treatment or who received a further adjustment of existing insulin treatment. Multinational, multicenter, non-interventional study was conducted in the Gulf region. The primary objective was to assess HbA1c reduction from baseline, to three and six months following treatment with insulin-based regimens. Secondary outcomes included the percentage of patients achieving the HbA1c target of <7.0% at 6 months, change in fasting, and postprandial blood glucose, insulin dose, body weight, the incidence of hypoglycemia, and patient characteristics associated with the success of glycemic control. Overall, 1196 patients from 102 centers were recruited and 1083 received a basal insulin-based therapy for six-months. Mean (SD) baseline characteristics were: age 56.2 ? 12 years, weight 82.7 ? 14.9 kg, BMI 29.8 ? 5.2 kg/m?, diabetes duration 11 ? 6.9 years, and 55% were male. Initiation or adjustment of basal insulin reduced mean HbA1c from 9.8% ? 1.6% to 7.6% ? 1% and mean FBG from 208.1 ? 70 mg/dl to 128.6 ? 32.3 mg/dl. At 6 months, 25.9% of patients achieved target HbA1c <7.0%. Predictors of glycemic control (HbA1c <7%) included age (OR = 1.01; p = 0.043), baseline HbA1c (OR = 0.68; p < 0.001), BMI (OR = 0.96; p = 0.012), and exercise (OR = 1.5; p = 0.036). Incidence of hypoglycemia was 5.3%, and no significant change in body weight was observed (p = 0.074). In conclusion, Basal insulin treatment with or without addition of prandial insulin is an efficacious and well tolerated regimen for T2DM patients from the Gulf regions inadequately controlled with oral antidiabetic drugs.
Diabetes/Metabolism Research and Reviews, 2016
Background This study used data from different sources to identify the extent of the unmet need for postprandial glycemic control in patients with type 2 diabetes mellitus (T2DM) after the initiation of basal insulin therapy in Europe, Asia Pacific, the United States, and Latin America. Methods Different levels of evidence were used as available for each country/region, with data extracted from seven randomized controlled trials (RCTs), three clinical trial registries (CTRs), and three electronic medical record (EMR) databases. Glycemic status was categorized as "well controlled" (glycated hemoglobin [HbA 1c ] at target [<7%]), "residual hyperglycemia" (fasting plasma glucose [FPG] but not HbA 1c at target [FPG <7.2/7.8 mmol/L, <130/140 mg/ dL, depending on country-specific recommendations]), or "uncontrolled" (both FPG and HbA 1c above target). Predictor factors were identified from the RCT data set using logistic regression analysis. Results RCT data showed that 16.9% to 28.0%, 42.7% to 54.4%, and 16.9% to 38.1% of patients with T2DM had well-controlled glycemia, residual hyperglycemia, and uncontrolled hyperglycemia, respectively. In CTRs, respective ranges were 21.8% to 33.6%, 31.5% to 35.6%, and 30.7% to 46.8%, and in EMR databases were 4.4% to 21.0%, 23.9% to 31.8%, and 53.6% to 63.8%. Significant predictor factors of residual hyperglycemia identified from RCT data included high baseline HbA 1c (all countries/regions except Brazil), high baseline FPG (United Kingdom/Japan), longer duration of diabetes (Brazil), and female sex (Europe/ Latin America). Conclusions Irrespective of intrinsic differences between data sources, 24% to 54% of patients with T2DM globally had residual hyperglycemia with HbA 1c not at target, despite achieving FPG control, indicating a significant unmet need for postprandial glycemic control. KEYWORDS fasting plasma glucose, glycemic control, insulin therapy, postprandial glucose, residual hyperglycemia, type 2 diabetes mellitus This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
Diabetes, metabolic syndrome and obesity : targets and therapy, 2015
When target glycated hemoglobin (HbA1c) levels are not reached, basal insulin therapy should be considered in type 2 diabetes. The objective of this report was to describe the predictors of glycemic control (strict criterion: HbA1c ≤6.5%) during the first year after initiating basal insulin therapy in primary care. The study applied a retrospective approach using a nationwide database in Germany (Disease Analyzer, IMS Health, January 2008 to December 2011, including 1,024 general and internal medicine practices). Potential predictors of glycemic control considered were age, sex, duration of diabetes, type of basal insulin, comedication with short-acting insulin, baseline HbA1c, previous oral antidiabetic drugs, diabetologist care, private health insurance, macrovascular and microvascular comorbidity, and concomitant medication. Multivariable logistic regression models were fitted with glycemic control as the dependent variable. A total of 4,062 type 2 diabetes patients started basal...
Diabetes Therapy, 2019
Introduction: This retrospective, observational cohort study evaluated the effect of therapy intensification on change in glycated hemoglobin (HbA1c) at 6 and 12 months post intensification in patients with type 2 diabetes (T2D) suboptimally controlled on basal insulin (BI) (i.e., HbA1c C 7.5% [C 58 mmol/mol]). Methods: Patients with T2D with suboptimal glycemic control using BI were identified from The Health Improvement Network (THIN) database. Patients who underwent therapy intensification (intensifiers) within 12 months of index 1 Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.8685155.
Diabetologia, 2020
Aims/hypothesis We evaluated the secular trend of glycaemic control in individuals with type 2 diabetes in developing countries, where data are limited. Methods The International Diabetes Management Practices Study provides real-world evidence of patient profiles and diabetes care practices in developing countries in seven cross-sectional waves (2005–2017). At each wave, each physician collected data from ten consecutive participants with type 2 diabetes during a 2 week period. The primary objective of this analysis was to evaluate trends of glycaemic control over time. Results A total of 66,088 individuals with type 2 diabetes were recruited by 6099 physicians from 49 countries. The proportion of participants with HbA1c <53 mmol/mol (<7%) decreased from 36% in wave 1 (2005) to 30.1% in wave 7 (2017) (p < 0.0001). Compared with wave 1, the adjusted ORs of attaining HbA1c ≤64 mmol/mol (≤8%) decreased significantly in waves 2, 5, 6 and 7 (p < 0.05). Over 80% of participant...
Saudi Journal of Internal Medicine, 2013
Background /Objective: The aim was to assess the glycemic control in patients with type 2 diabetes mellitus using American Diabetes Association HbA1c definition of good control of ≤ 7.0%. Methods: This retrospective study conducted in internal medicine outpatient clinics at King Abdulaziz Medical City in Riyadh, Kingdom of Saudi Arabia. All patients with type 2 diabetes mellitus attending the clinic from August 2005 to January 2006 were evaluated. Patients with HbA1c measured regularly and under anti-diabetic therapy were included in the study. Last measured HbA1c was used to evaluate diabetic control. Results: Data for 968 (81.5%) patients out of 1188 were available for analysis. Only 211 (21.8%) patients had their HbA1c within the American Diabetes Association recommended target of HbA1c ≤ 7%. Mean HbA1c was 8.98%. Patients were stratified into groups of good (HbA1c £ 7%), average (HbA1c 7.1% - 9.9%) and poor diabetic control (HbA1c ≥ 10%) included 21.8%, 46.2% and 32.0% of ...
Journal of Endocrinology and Metabolism
Background: Type 2 diabetes mellitus (T2DM) is often characterized by insulin resistance and progressive β-cell deterioration. With longer duration of T2DM most patients treated with oral antihyperglycemic drugs (OADs), in monotherapy or in combination, will ultimately require basal insulin therapy and even further prandial intensification later on. The basal-plus regimen is one of the proposed approaches for treatment intensification by adding one injection of prandial rapid-acting insulin to basal insulin. The CONBA+ study aimed to collect real-world data of glycemic control of T2DM patients uncontrolled on insulin/OAD therapy using the basal-plus approach in Morocco. Methods: CONBA+ study was a national, prospective, non-interventional, multicenter study involving 50 endocrinologists from Morocco. The study, conducted between June 2015 and June 2017, enrolled T2DM patients uncontrolled on their previous regimen (hemoglobin A1c (HbA1c) ≥ 7.5% on two OADs, glargine 100 U/ mL and OADs or once daily premixed insulin). Patients continued or newly initiated once-daily insulin glargine 100 U/mL (Gla-100) and also received one injection of insulin glulisine (Glu) at the main meal in replacing any previous treatment. Demographics, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), postprandial glucose (PPG), insulin doses and the frequency of hypoglycemia were assessed at baseline and at 12 and 24 weeks after study entry. Results: Overall, 854 people (46.8% men) fulfilled the inclusion criteria. At baseline, mean age was 59.0 ± 9.4 years, mean duration of diabetes 10.8 ± 6.7 years (range: 1-45 years), mean body mass index (BMI) 27.4 ± 4.0 kg/m 2 and mean HbA1c 9.50±1.51%. After 24 weeks, 33.0% of patients achieved target HbA1c < 7.0% (primary endpoint). In addition, mean FPG and postprandial blood glucose (PPBG) improved significantly at week 24 (change from baseline:-88 mg/dL and-108 mg/dL respectively; P < 0.001) while the number of reported severe hypoglycemia was low. Conclusions: The use of a basal-plus regimen consisting of insulin glargine 100 U/mL and insulin glulisine injected at the main meal resulted in significant improvements of glycemic parameters. In addition, the basal-plus approach showed a good safety profile with a low risk of hypoglycemia.