Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea
Journal
Diabetes Research and Clinical Practice
Journal Volume
83
Journal Issue
1
Pages
69-76
Date Issued
2009
Author(s)
Gao Y.
Yoon K.H.
Mohan V.
Ning G.
Shah S.
Jang H.C.
Wu T.-J.
Johns D.
Northrup J.
Brodows R.
Abstract
Aims: To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents. Methods: Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 μg then 10 μg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA1c change. Results: 466 patients (age 54 ± 9 years, weight 68.7 ± 11.2 kg, BMI 26.3 ± 3.3 kg/m2, and HbA1c 8.3 ± 1.1%; mean ± S.D.) were enrolled in the full analysis set. Endpoint HbA1c reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 [-1.3, -1.1]% vs. -0.4 [-0.5, -0.2]%, p < 0.001). More exenatide- than placebo-treated patients achieved HbA1c ?7% (48% vs. 17%, p < 0.001). At endpoint, weight reduction was greater with exenatide (-1.2 [-1.5, -0.9] kg) than placebo (-0.1 [-0.3, 0.2] kg), p < 0.001. Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo). The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p < 0.001). Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively. Conclusion: Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients. ? 2008 Elsevier Ireland Ltd. All rights reserved.
SDGs
Other Subjects
exendin 4; hemoglobin A1c; metformin; placebo; sulfonylurea; abdominal distension; adult; aged; anorexia; arthralgia; article; Asian; body mass; chronic cholecystitis; clinical trial; controlled clinical trial; controlled study; cyst; diabetic patient; diarrhea; dizziness; double blind procedure; drug dose reduction; drug efficacy; drug safety; drug withdrawal; dyspepsia; female; fever; glycemic control; headache; human; hypoglycemia; major clinical study; male; nausea; non insulin dependent diabetes mellitus; randomized controlled trial; rhinopharyngitis; upper respiratory tract infection; vomiting; weight; weight reduction; Asian Continental Ancestry Group; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; Male; Metformin; Middle Aged; Peptides; Sulfonylurea Compounds; Venoms
Type
journal article