Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea

Yan Gao; Kun Ho Yoon; Lee Ming Chuang; Viswanathan Mohan; Guang Ning; Sanjiv Shah; Hak Chul Jang; Ta Jen Wu; Don Johns; Justin Northrup; Robert Brodows

doi:10.1016/j.diabres.2008.09.037

Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea

Yan Gao, Kun Ho Yoon, Lee Ming Chuang, Viswanathan Mohan, Guang Ning, Sanjiv Shah, Hak Chul Jang, Ta Jen Wu, Don Johns, Justin Northrup, Robert Brodows

Division of Endocrinology & Metabolism

Research output: Contribution to journal › Article › peer-review

76 Scopus citations

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 HbA_1c change. Results: 466 patients (age 54 ± 9 years, weight 68.7 ± 11.2 kg, BMI 26.3 ± 3.3 kg/m², 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.

Original language	English
Pages (from-to)	69-76
Number of pages	8
Journal	Diabetes Research and Clinical Practice
Volume	83
Issue number	1
DOIs	https://doi.org/10.1016/j.diabres.2008.09.037
State	Published - Jan 2009

Bibliographical note

Funding Information:
This study was funded by Amylin Pharmaceuticals, Inc., San Diego, CA and Eli Lilly and Company, Indianapolis, IN. Three of the named authors (DJ, JN, RB) are employees of Eli Lilly and Company. All of the contributing authors would like to thank Zoe Zuk Kuen Lee, Anna Shen, Yi Fang Hsiao, Min Kyung Kang, Ya Hua Huang, and Maria C. Jimenez for their assistance with preparing this manuscript for publication. The authors also wish to thank the following investigators and their staffs for participating in the study: Guangwei Li, Beijing, China; Xiaohui Guo, Beijing, China; Zhimin Liu, Shanghai, China; Jianhua Ma, Nanjing, China; Chao Liu, Nanjing, China; Haoming Tian, Chengdu, China; Weiping Jia, Shanghai, China; Bong Soo Cha, Seoul, Korea; Moon Kyu Lee, Seoul, Korea; Kwan-Woo Lee, Kyunggi-Do, Korea; Sung-Rae Kim, Gyeonggi-Do, Korea; Vijay Viswanathan, Chennai, India; Shreerang Godbole, Pune, India; Wayne H-H Sheu, Taichung, Taiwan; Chieh-Hsiang Lu, Chiayi, Taiwan; Kuang-Chung Shih, Taipei, Taiwan.

Keywords

Asian
Ethnic variation
Exenatide
Type 2 diabetes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.diabres.2008.09.037

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Gao, Y., Yoon, K. H., Chuang, L. M., Mohan, V., Ning, G., Shah, S., Jang, H. C., Wu, T. J., Johns, D., Northrup, J., & Brodows, R. (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. https://doi.org/10.1016/j.diabres.2008.09.037

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title = "Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea",

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.",

keywords = "Asian, Ethnic variation, Exenatide, Type 2 diabetes",

author = "Yan Gao and Yoon, {Kun Ho} and Chuang, {Lee Ming} and Viswanathan Mohan and Guang Ning and Sanjiv Shah and Jang, {Hak Chul} and Wu, {Ta Jen} and Don Johns and Justin Northrup and Robert Brodows",

note = "Funding Information: This study was funded by Amylin Pharmaceuticals, Inc., San Diego, CA and Eli Lilly and Company, Indianapolis, IN. Three of the named authors (DJ, JN, RB) are employees of Eli Lilly and Company. All of the contributing authors would like to thank Zoe Zuk Kuen Lee, Anna Shen, Yi Fang Hsiao, Min Kyung Kang, Ya Hua Huang, and Maria C. Jimenez for their assistance with preparing this manuscript for publication. The authors also wish to thank the following investigators and their staffs for participating in the study: Guangwei Li, Beijing, China; Xiaohui Guo, Beijing, China; Zhimin Liu, Shanghai, China; Jianhua Ma, Nanjing, China; Chao Liu, Nanjing, China; Haoming Tian, Chengdu, China; Weiping Jia, Shanghai, China; Bong Soo Cha, Seoul, Korea; Moon Kyu Lee, Seoul, Korea; Kwan-Woo Lee, Kyunggi-Do, Korea; Sung-Rae Kim, Gyeonggi-Do, Korea; Vijay Viswanathan, Chennai, India; Shreerang Godbole, Pune, India; Wayne H-H Sheu, Taichung, Taiwan; Chieh-Hsiang Lu, Chiayi, Taiwan; Kuang-Chung Shih, Taipei, Taiwan. ",

year = "2009",

month = jan,

doi = "10.1016/j.diabres.2008.09.037",

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Gao, Y, Yoon, KH, Chuang, LM, Mohan, V, Ning, G, Shah, S, Jang, HC, Wu, TJ, Johns, D, Northrup, J & Brodows, R 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, vol. 83, no. 1, pp. 69-76. https://doi.org/10.1016/j.diabres.2008.09.037

TY - JOUR

T1 - Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea

AU - Gao, Yan

AU - Yoon, Kun Ho

AU - Chuang, Lee Ming

AU - Mohan, Viswanathan

AU - Ning, Guang

AU - Shah, Sanjiv

AU - Jang, Hak Chul

AU - Wu, Ta Jen

AU - Johns, Don

AU - Northrup, Justin

AU - Brodows, Robert

N1 - Funding Information: This study was funded by Amylin Pharmaceuticals, Inc., San Diego, CA and Eli Lilly and Company, Indianapolis, IN. Three of the named authors (DJ, JN, RB) are employees of Eli Lilly and Company. All of the contributing authors would like to thank Zoe Zuk Kuen Lee, Anna Shen, Yi Fang Hsiao, Min Kyung Kang, Ya Hua Huang, and Maria C. Jimenez for their assistance with preparing this manuscript for publication. The authors also wish to thank the following investigators and their staffs for participating in the study: Guangwei Li, Beijing, China; Xiaohui Guo, Beijing, China; Zhimin Liu, Shanghai, China; Jianhua Ma, Nanjing, China; Chao Liu, Nanjing, China; Haoming Tian, Chengdu, China; Weiping Jia, Shanghai, China; Bong Soo Cha, Seoul, Korea; Moon Kyu Lee, Seoul, Korea; Kwan-Woo Lee, Kyunggi-Do, Korea; Sung-Rae Kim, Gyeonggi-Do, Korea; Vijay Viswanathan, Chennai, India; Shreerang Godbole, Pune, India; Wayne H-H Sheu, Taichung, Taiwan; Chieh-Hsiang Lu, Chiayi, Taiwan; Kuang-Chung Shih, Taipei, Taiwan.

PY - 2009/1

Y1 - 2009/1

N2 - 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.

AB - 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.

KW - Asian

KW - Ethnic variation

KW - Exenatide

KW - Type 2 diabetes

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U2 - 10.1016/j.diabres.2008.09.037

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M3 - Article

C2 - 19019476

AN - SCOPUS:57949096314

SN - 0168-8227

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SP - 69

EP - 76

JO - Diabetes Research and Clinical Practice

JF - Diabetes Research and Clinical Practice

IS - 1

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Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea

Abstract

Bibliographical note

Keywords

UN SDGs

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