Difference In HbA1c Reduction Research Articles

Clinical Effectiveness of Biphasic Insulin Aspart 30:70 Versus Biphasic Human Insulin 30 in UK General Clinical Practice: A Retrospective Database Study

BackgroundPremixed, or biphasic, insulins containing varying proportions of rapid- and intermediate-acting insulin components have been developed to limit the number of daily injections for patients who require both prandial and basal insulin injections. ObjectivesThis study was conducted to determine whether there were differences in glycosylated hemoglobin (HbA1c), weight change, hypoglycemia occurrence, and treatment discontinuation between patients treated with biphasic insulin aspart 30 (BIAsp-30) or biphasic human insulin 30 (BHI-30) in UK general practice. MethodsData were from >350 general practices from the United Kingdom. Patients were stratified by treatment regimen, diabetes type, and insulin status (naive or experienced). Changes in HbA1c and weight were compared from baseline (the date of the first prescription for either insulin) through 180 days of follow-up using ANCOVA. Hypoglycemia incidence rate ratios were compared, and the adjusted likelihood of hypoglycemia was evaluated by logistic regression. Rates of treatment discontinuation were compared using the Cox proportional hazards model. ResultsThe study included data from 7720 patients, of whom 1333 (17.3%) had type 1 diabetes and 4457 (57.7%) were male. Patients' mean (SD) age was 57.9 (19.8) years, and their mean body mass index was 29.5 (6.2) kg/m2. The difference in HbA1c reduction was significant for BIAsp-30 compared with BHI-30 in insulin-naive patients with type 1 diabetes (0.57%; P = 0.045), insulin-naive patients with type 2 diabetes (–0.17%; P = 0.003), and insulin-experienced patients with type 2 diabetes (–0.23%; P = 0.007). The difference between insulins was not significant in insulin-experienced patients with type 1 diabetes. Five hundred ninety-four patients (7.7%) experienced at least one hypoglycemic event. The incidence rate ratio for reported hypoglycemia was significantly lower with BIAsp-30 compared with BHI-30 in insulin-naive patients with type 2 diabetes (0.74; 95% CI, 0.62–0.89; P = 0.001); the difference between insulins was not significant in the other groups. The adjusted hazard ratio for treatment discontinuation was significant for BIAsp-30 versus BHI-30 in insulin-experienced patients with type 2 diabetes (0.693; 95% CI, 0.543–0.884; P = 0.003), whereas the hazard ratios for the other groups did not reach statistical significance. There were no significant differences in weight change between BIAsp-30 and BHI-30 in any of the groups. ConclusionsIn this analysis, BIAsp-30 was associated with improved glycemic control (HbA1c) compared with BHI-30 in insulin-naive patients with type 1 or type 2 diabetes and insulin-experienced patients with type 2 diabetes. BIAsp-30 was associated with reduced hypoglycemia in insulin-naive patients with type 2 diabetes and lower rates of treatment discontinuation in insulin-experienced patients with type 2 diabetes. Cambridgeshire Research Ethics Committee: REC 08/H0305/47.

Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966–2004)

ABSTRACTObjective: To determine if therapeutic management programs that include self-monitoring of blood glucose result in greater HbA1c reduction in non-insulin-requiring type 2 diabetes patients compared to programs without blood glucose self-monitoring.Research design and methods: Electronic databases including MEDLINE (1966–2004), Cochrane Database of Systematic Reviews, EMBASE (1950–2004), Centre for Reviews and Dissemination (CRD) and the Online Index Journals of the American Diabetes Association (ADA 1978–2004) were searched. Personal collections of investigators were also explored. Randomized controlled trials comparing HbA1c reduction in therapies with and without blood glucose self-monitoring among adult, non-insulin-treated type 2 diabetes patients were selected. Studies on patients who are pregnant, taking insulin, troglitazone or experimental drugs were excluded. Out of 14 potentially useful randomized controlled trials on self-monitoring of blood glucose in non-insulin treated type 2 diabetes patients, eight studies with a total of 1307 subjects were included in the analysis. Two independent reviewers assessed the quality of studies.Main outcome measure: The effect of SMBG was assessed by means of meta-analysis of the difference in HbA1c reduction between self-monitoring and non-self-monitoring groups.Results: Antidiabetic therapies that included blood glucose self-monitoring as part of a multi-component management strategy produced a mean additional HbA1c reduction of –0.39% (95%CI: –0.54%, –0.23%) under the fixed effects model and –0.42% (95%CI: –0.63%, –0.21%) under the random effects model, when compared to therapies that did not. Heterogeneity among studies was not statistically significant.Conclusion: Multi-component diabetes management programs with self-monitoring of blood glucose result in better glycemic control among non-insulin-using type 2 diabetes patients.

Efficacy and safety profile of glimepiride in Mexican American Patients with type 2 diabetes mellitus: A randomized, placebo-controlled study

Background: Mexican Americans, the fastest growing ethnic group in the United States, have a 2- to 3-fold higher prevalence of type 2 diabetes mellitus relative to the non-Hispanic white population. It is estimated that 10% of Mexican Americans ⩾20 years of age have diabetes. Objective: The goal of this study was to evaluate the efficacy and safety of glimepiride, a long-acting sulfonylurea, as an adjunct to diet/exercise in Mexican Americans with type 2 diabetes mellitus. Methods: This was a multicenter, randomized, double-blind, placebo-controlled study. Mexican Americans with uncontrolled type 2 diabetes, defined as a fasting plasma glucose (FPG) level between 120 mg/dL and 225 mg/dL and glycated hemoglobin (HbA 1c) values between 8.0% and 10.5%, after ⩾3 months of diet/exercise were enrolled. Patients were randomized in a 2:1 ratio (using the lowest available treatment assignment number when eligibility was established) to receive 14 weeks of glimepiride or matching placebo once daily with continued diet/exercise. The starting glimepiride dose was 1 mg, with titration to 2 mg and 4 mg for FPG levels >120 mg/dL. The primary efficacy variable was change in HbA 1c from baseline to study end point. Secondary efficacy variables were HbA 1c response (rated as excellent, good, or marginal) and changes in FPG, fasting insulin, fibrinogen, and plasminogen activator inhibitor-1 (PAI-1) levels from baseline to study end point. The tolerability of glimepiride in this study population was determined by evaluating adverse events, hypoglycemic episodes, and physical examination as well as laboratory findings. All analyses were performed on an intent-to-treat basis. A per-protocol analysis also was conducted to support the primary efficacy analysis. Results: Seventy patients were randomized to treatment with glimepiride (n = 48) or placebo ((n = 22). The glimepiride and placebo groups were similar with respect to mean (SE) age (48.4 [11.7] and 50.7 [10.0] years, respectively) and sex (56.3% [27/48] and 50.0% [11/22] were male, respectively). However, the glimepiride group had a higher mean body weight (83.3 [17.0] vs 76.3 [18.5] kg) and a significantly higher mean fasting insulin level (23.8 [17.7] vs 17.8 [19.7] μU/mL; P = 0.031). The mean (SE) HbA 1c values at study end point were 7.8% (0.2%) and 9.9% (0.7%) in patients receiving glimepiride and placebo, respectively. The adjusted mean difference in HbA 1c reduction from baseline to end point was statistically significant in favor of glimepiride (−1.8% [0.4%]; P < 0.001). More pronounced HbA 1c impairment at baseline was associated with greater glimepiride-placebo differences in HbA 1c reduction. Glimepiride-treated patients also achieved a significantly greater improvement in FPG, with an adjusted mean (SE) treatment difference of −46.7 (16.7) mg/dL ( P = 0.007). Glimepiride did not appear to affect fibrinogen and PAI-1 levels but was associated with significantly greater mean increases in fasting insulin (10.2 vs −2.1 μU/mL; P = 0.002) and body weight (2.3 vs 2.1 kg; P < 0.001) compared with placebo. Glimepiride was well tolerated, with an adverse-event profile similar to that of placebo. Conclusions: These results indicate that once-daily glimepiride plus diet/exercise was effective in Mexican Americans with type 2 diabetes whose disease was inadequately controlled with diet/exercise alone. It appeared to be well tolerated in the population studied. More weight gain was seen with glimepiride compared with placebo. Given the high prevalence of type 2 diabetes among Mexican Americans, further clinical studies of glimepiride and other glucose-lowering therapies are needed in this ethnic subset.