|Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea|
|Gao, Yan2; Yoon, Kun Ho3; Chuang, Lee-Ming4; Mohan, Viswanathan5; Ning, Guang6; Shah, Sanjiv7; Jang, Hak Chul8; Wu, Ta-Jen9; Johns, Don; Northrup, Justin; Brodows, Robert1|
|关键词||Exenatide Type 2 diabetes Asian Ethnic variation|
|刊名||DIABETES RESEARCH AND CLINICAL PRACTICE|
|WOS标题词||Science & Technology|
|类目[WOS]||Endocrinology & Metabolism|
|研究领域[WOS]||Endocrinology & Metabolism|
|关键词[WOS]||BETA-CELL FUNCTION ; INSULIN SENSITIVITY ; GLUCOSE-TOLERANCE ; GLYCEMIC CONTROL ; VISCERAL ADIPOSITY ; TREATED PATIENTS ; EXENDIN-4 ; PHARMACOKINETICS ; SECRETION ; MEN|
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 mu g then 10 mu g 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 +/- 1.1.2 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) <= 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. (C) 2008 Elsevier Ireland Ltd. All rights reserved.
|资助机构||Amylin Pharmaceuticals, Inc., San Diego, CA ; Eli Lilly and Company, Indianapolis, IN|
|作者单位||1.Madras Diabet Res Fdn, Diabet Special Ctr, Madras, Tamil Nadu, India|
2.Medihts Healthcare Pvt Ltd, Bombay, Maharashtra, India
3.Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA
4.Peking Univ, Hosp 1, Dept Endocrinol, Beijing 100871, Peoples R China
5.Catholic Univ Korea, Kangnam St Marys Hosp, Dept Endocrinol & Metab, Seoul, South Korea
6.Natl Taiwan Univ Hosp, Dept Internal Med, Taipei 100, Taiwan
7.Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Endocrinol & Metab, Shanghai 200030, Peoples R China
8.Seoul Natl Univ, Bundang Hosp, Dept Internal Med, Songnam, South Korea
9.Natl Cheng Kung Univ Hosp, Dept Internal Med, Div Endocrinol & Metab, Tainan 70428, Taiwan
|Gao, Yan,Yoon, Kun Ho,Chuang, Lee-Ming,et al. Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea[J]. DIABETES RESEARCH AND CLINICAL PRACTICE,2009,83(1):69-76.|
|APA||Gao, Yan.,Yoon, Kun Ho.,Chuang, Lee-Ming.,Mohan, Viswanathan.,Ning, Guang.,...&Brodows, Robert.(2009).Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea.DIABETES RESEARCH AND CLINICAL PRACTICE,83(1),69-76.|
|MLA||Gao, Yan,et al."Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea".DIABETES RESEARCH AND CLINICAL PRACTICE 83.1(2009):69-76.|
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