Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2)

Autor: Qiu He Ji, Li Ying Du, Ling Li, Yan Li, Jia Ning Hou, Guang Yao Song, Yong De Peng, Shan Dong Ye
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Diabetes Therapy
ISSN: 1869-6961
1869-6953
Popis: Introduction To evaluate efficacy and safety data of dulaglutide in Chinese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with 1–2 oral antihyperglycemic medications (OAMs). Methods This is a subgroup analysis of a phase 3, open-label, randomized, parallel-arm, 52-week study in Chinese patients aged ≥ 18 years with T2DM who had inadequate glycemic control with OAMs (glycated hemoglobin [HbA1c] ≥ 7.0% and ≤ 11.0%). The primary endpoint was assessment of the noninferiority of dulaglutide 1.5 mg as measured by change in HbA1c, compared with insulin glargine (glargine), using a 0.4% noninferiority margin at week 26. Results A total of 607 patients from China were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or once-daily glargine. At week 26, the least squares mean (LSM) change from baseline in HbA1c was greater with dulaglutide 1.5 mg (− 1.67%) and dulaglutide 0.75 mg (− 1.31%) compared with glargine (− 1.11%). The LSM (95% confidence interval) for the difference of dulaglutide 1.5 mg and 0.75 mg vs glargine was − 0.56% (− 0.75 to − 0.37) and − 0.20% (− 0.39 to − 0.01), respectively. Both doses of dulaglutide were noninferior and superior to glargine at 26 weeks and 52 weeks (two-sided P value
Databáze: OpenAIRE
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