Safety and efficacy of twice-daily exenatide in Taiwanese patients with inadequately controlled type 2 diabetes mellitus
Journal
Journal of the Formosan Medical Association
Journal Volume
112
Journal Issue
3
Pages
144-150
Date Issued
2013
Author(s)
Abstract
Background/Purpose: Exenatide has been predominantly studied in non-Asian populations. The purpose of this study was to investigate the safety and efficacy of twice-daily (BID) exenatide versus placebo in a subpopulation of Taiwanese patients from a larger study on Asian patients. Methods: Patients unable to achieve glycemic control with metformin alone or metformin in combination with sulfonylurea were randomly assigned to self-administer either 5. μg exenatide or placebo BID for 4 weeks, then 10. μg exenatide or placebo BID for an additional 12 weeks, in addition to their regular oral therapy. Results: Fifty patients from Taiwan were enrolled in this study (54.0% male; age: 50.9. ±. 9.4 years; weight: 71.0. ±. 11.6. kg; 8.1. ±. 1.0% hemoglobin A1c (HbA1c)). The exenatide-treated patients demonstrated a statistically significant greater reduction in HbA1c from baseline to the endpoint (least-squares [LS] mean [95% confidence interval (CI)]: -0.8% [-1.4--0.2]; p=. 0.009) compared with patients who received placebo (LS mean [95% CI]: -0.1% [-0.7-0.4]) with an LS mean [95% CI] between-group difference of -0.7% (-1.3--0.1) (. p=. 0.025). A statistically significant higher number of exenatide-treated patients achieved HbA1c targets of ? 7% (. p=. 0.020) and ? 6.5% (. p=. 0.021) by the endpoint compared with patients who received placebo. Exenatide-treated patients experienced a statistically significant reduction in weight from baseline to endpoint (exenatide-placebo adjusted mean difference [95% CI]: -1.6. kg [-2.7--0.6]; p=. 0.004) compared with the placebo group. The symptomatic hypoglycemia rate (mean patient/year. ±. standard deviation) was higher in exenatide-treated patients (4.86 mean patient/year. ±. 7.36) than placebo-treated patients (0.27 mean patient/year. ±. 1.32). Thirteen (50.0%) exenatide-treated patients and nine (37.5%) placebo-treated patients reported one or more treatment-emergent adverse events; nausea was the most frequently reported side effect (exenatide, 4 [15.4%]; placebo, 0 [0.0%]). Conclusion: This subgroup analysis of Taiwanese patients was consistent with the overall study results, which showed that exenatide BID is superior to placebo for improving glycemic control in Asian patients with type 2 diabetes who experienced inadequate glycemic control when using oral antidiabetic therapy. ? 2012 Elsevier Taiwan LLC & Formosan Medical Association.
SDGs
Other Subjects
exendin 4; hemoglobin A1c; metformin; placebo; sulfonylurea; adult; aged; article; body weight; clinical article; constipation; controlled study; coughing; decreased appetite; diarrhea; dizziness; drug dose increase; drug efficacy; drug safety; female; glycemic control; human; hypoglycemia; male; nausea; non insulin dependent diabetes mellitus; randomized controlled trial; Adult; Aged; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Female; Hemoglobin A, Glycosylated; Humans; Hypoglycemic Agents; Male; Middle Aged; Peptides; Venoms
Type
journal article