Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea.
OBJECTIVE
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 microg then 10 microg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA(1c) change.


RESULTS
466 patients (age 54+/-9 years, weight 68.7+/-11.2 kg, BMI 26.3+/-3.3 kg/m(2), and HbA(1c) 8.3+/-1.1%; mean+/-S.D.) were enrolled in the full analysis set. Endpoint HbA(1c) 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 HbA(1c) <or=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.


CONCLUSIONS
Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients.
Gao
Yan
Y
Department of Endocrinology, Peking University First Hospital, Beijing, China.
Yoon
Kun Ho
KH
Chuang
Lee-Ming
LM
Mohan
Viswanathan
V
Ning
Guang
G
Shah
Sanjiv
S
Jang
Hak Chul
HC
Wu
Ta-Jen
TJ
Johns
Don
D
Northrup
Justin
J
Brodows
Robert
R
D044466:Asian People; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000208:ethnology; D000077270:Exenatide; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D014688:Venoms / Q000627:therapeutic use*
D007004:Hypoglycemic Agents; D010455:Peptides; D013453:Sulfonylurea Compounds; D014688:Venoms; D008687:Metformin; D000077270:Exenatide