insulin-glulisine and Body-Weight

Glucose fluctuation often remains to be corrected under basal-supported oral therapy. We investigated the efficacy of adding once-daily rapid-acting insulin in Japanese diabetes patients treated with basal-supported oral therapy.. In this 8-week, parallel-group, randomized, open-label trial, 62 Japanese adults with type 2 diabetes treated with insulin glargine and 50 mg of sitagliptin were randomized into the following two arms: the single-bolus group, in which once-daily insulin glulisine was initiated at a main meal at a fifth (i.e., 20%) the dose of insulin glargine, and the control group, in which the dose of sitagliptin was maximized to 100 mg. The primary end point was the change of glycemic fluctuation assessed with the M-value.. Baseline hemoglobin A1c levels, mean blood glucose profiles, and M-value were 7.2 ± 0.6%, 9.3 ± 1.7 mmol/L, and 21 ± 13 units, respectively. At the end of the study, the single-bolus group had a greater reduction of M-value than the control group (P=0.02); the difference was 6.5 units (95% confidence interval, 1.1-11.9 units). The single-bolus group also had a greater reduction of mean blood glucose levels (P=0.01). There were no significant differences in the incidence of hypoglycemia or the weight change between the two groups (P>0.05).. Adding once-daily insulin glulisine was more effective in controlling the glycemic fluctuation in Japanese type 2 diabetes patients treated with insulin glargine together with sitagliptin.

Topics: Adult; Asian People; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Japan; Male; Middle Aged; Pyrazines; Sitagliptin Phosphate; Time Factors; Treatment Outcome; Triazoles

In patients with diabetes, intraday glucose variability might predict health outcomes independently from glycosylated hemoglobin (HbA1c).. Our objective was to evaluate patient satisfaction (PS), quality of life (QoL), glycemic control, and variability during insulin intensification to HbA1c below 7.0%.. Eighty-two type 1 and 306 insulin-treated type 2 diabetes patients (47% male; age 54±11 yr; HbA1c=7.8±0.7%) participated in this multicenter, randomized, crossover trial at 52 U.S. centers.. Interventions included insulin glargine plus premeal glulisine (n=192) vs. twice-daily premix 75/25 or 70/30 analog insulin (n=196) for 12 wk and crossed to the alternate arm for 12 wk.. Main outcome measures included PS and QoL questionnaires, 3-d continuous glucose monitoring (CGM), and HbA1c every 4-8 wk.. Mean±se HbA1c change was -0.39±0.09% for glargine-glulisine and -0.05±0.09% for premix (P<0.0001). The PS net benefit scale (0-100) improved from 51.1 to 60.5±1.2 for glargine-glulisine and worsened to 45.4±1.2 for premix (P<0.0001). The PS regimen acceptance scale was comparable (P=0.33). Overall QoL favored glargine-glulisine (P<0.001), as did perceived health (P<0.0001), symptom distress (P<0.0001), general health perceptions (P<0.01), and psychosocial (P<0.02). CGM daily glucose mean, daily glucose sd (glycemic variability), and percent time over 140 mg/dl were lower for glargine-glulisine by 13.1±2.7 mg/dl, 5.9±1.4 mg/dl, and 7.3±1.6%, respectively (all P<0.0001), with no difference in CGM percent time below 70 mg/dl (P=0.09). Symptomatic hypoglycemia rates were comparable. HbA1c, mean CGM daily glucose, and glycemic variability were independent predictors of PS net benefit.. Patient satisfaction was impacted more positively by improved QoL, reduced glucose variability, and better glycemic control with a basal-bolus regimen than negatively by the burden of additional injections, thereby facilitating insulin intensification and the ability to achieve HbA1c below 7.0%.

Topics: Adult; Aged; Blood Glucose; Body Weight; Cross-Over Studies; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Male; Middle Aged; Patient Satisfaction; Quality of Life; Surveys and Questionnaires

Several studies suggest benefits of insulin analogues detemir or glulisine in overweight and obese patients with type 2 diabetes. The present multicentre study therefore examines, whether these insulin analogues are used more frequently in patients with increased body mass index.. Data of 38 560 adult type 2 diabetic patients using insulin analogues, from 150 centres in Germany, registered in a standardized, prospective, computer-based documentation program (DPV), were included. Patients were classified into body mass index categories according to World Health Organization. Analysis was stratified by 3 time periods. To adjust for confounding effects, multivariable logistic regression models were created.. Detemir was preferentially used in overweight (OR 1.36, 95%-CI 1.20-1.53) and obese patients (OR 2.06, 95%-CI 1.84-2.31) compared to normal-weight patients. These effects remained significant after adjusting for sex, age, new/old federal state of Germany, size of centre, treatment in university clinic and clinic/specialized private practice. Models were additionally adjusted for time period and interaction of BMI category with age or sex. For glulisine, a minor effect was present when comparing obese to normal-weight patients (OR 1.26, 95%-CI 1.06-1.50). After adjustment, this finding was no longer significant. Stratified by obesity grade, class III obese patients more frequently used detemir or glulisine compared to class I obese patients. Comparing time periods, odds ratios did not differ, neither for detemir nor for glulisine..  Detemir is used more often in overweight and obese patients compared to normal-weight patients. For glulisine, the relationship is less pronounced.

Topics: Aged; Body Weight; Databases, Factual; Diabetes Mellitus, Type 2; Drug Prescriptions; Female; Germany; Humans; Hypoglycemic Agents; Insulin; Insulin Detemir; Insulin, Long-Acting; Male; Middle Aged; Obesity; Overweight; Practice Patterns, Physicians'; Registries

Premixed insulin regimens are commonly used for type 2 diabetes mellitus (T2DM) patients. However, there is limited information regarding next-step therapy options in cases where premixed insulin does not provide adequate glycaemic control. This 12-week observational study of everyday clinical practice evaluated the efficacy and safety of insulin glargine (glargine) plus oral antidiabetic drugs (OADs) in T2DM patients previously treated with premixed insulin.. Type 2 diabetes mellitus patients taking premixed insulin were identified from German clinics and were eligible to switch to glargine plus OADs at the physicians' and patients' discretion, as part of routine clinical practice. The study design and conduct was in accordance with German regulations. Fasting blood glucose (FBG), 2-h postprandial blood glucose (PPBG) and glycosylated haemoglobin (HbA(1c)) were measured at the start and after a 12-week observation period.. A total of 5045 patients were followed-up and received glargine plus OADs. FBG [start to end-point: 9.9 +/- 2.7 to 6.9 +/- 1.5 mmol/l (178 +/- 48 to 124 +/- 26 mg/dl); p < or = 0.001], 2-h PPBG [10.8 +/- 2.8 to 7.8 +/- 1.5 mmol/l (195 +/- 50 to 140 +/- 27 mg/dl)] and HbA(1c) (8.3 +/- 1.2 to 7.2 +/- 0.8%; p < or = 0.001) improved significantly from start to end-point, respectively. A total of 48.9%, 38.4% and 73.9% of patients had FBG < 6.7 mmol/l (< 120 mg/dl), 2-h PPBG < 7.2 mmol/l (< 130 mg/dl) or HbA(1c) < 7.5%, respectively, after 12 weeks. Significant reductions in body weight were observed between the start and end of the observation period. A total of 71 adverse events were reported by 38 patients. Hypoglycaemia was the most common event (n = 16).. This observational study shows that, in T2DM patients inadequately controlled with premixed insulin, switching therapy to glargine plus OADs is associated with significant improvements in FBG and HbA(1c), and is well tolerated in everyday clinical practice. Further intensification of insulin therapy, perhaps by adding one or more injections of prandial insulin, would help provide further improvements in glycaemic control in these patients.

Topics: Administration, Oral; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Humans; Hyperglycemia; Hypoglycemic Agents; Insulin; Male; Middle Aged; Treatment Outcome