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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-06-21

AUTHORS

Yan Li, Ling Li, Yong De Peng, Guang Yao Song, Shan Dong Ye, Li Ying Du, Jia Ning Hou, Qiu He Ji

ABSTRACT

IntroductionTo 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).MethodsThis 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.ResultsA 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 < 0.05). The mean body weight decreased (P < 0.001) and total hypoglycemia rates were lower (P < 0.05) in the dulaglutide groups compared with the glargine group. Gastrointestinal adverse events (AEs) were the most frequently reported AEs in dulaglutide groups.ConclusionBoth doses of dulaglutide are efficacious and tolerable in Chinese patients with T2DM who had inadequate glycemic control on OAMs.Trial RegistrationClinicalTrials.gov identifier, NCT01648582.FundingEli Lilly and Company. More... »

PAGES

1435-1452

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s13300-019-0646-y

DOI

http://dx.doi.org/10.1007/s13300-019-0646-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1117299789

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/31228090


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183 grid-institutes:grid.412478.c schema:alternateName Department of Endocrinology, Shanghai First People’s Hospital, Shanghai, China
184 schema:name Department of Endocrinology, Shanghai First People’s Hospital, Shanghai, China
185 rdf:type schema:Organization
186 grid-institutes:grid.412536.7 schema:alternateName Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
187 schema:name Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
188 rdf:type schema:Organization
189 grid-institutes:grid.417295.c schema:alternateName Xijing Hospital, The Fourth Military Medical University, Xi’an, Shanxi, China
190 schema:name Xijing Hospital, The Fourth Military Medical University, Xi’an, Shanxi, China
191 rdf:type schema:Organization
192 grid-institutes:grid.440208.a schema:alternateName Department of Endocrinology, Hebei General Hospital, Shijiazhuang, Hebei, China
193 schema:name Department of Endocrinology, Hebei General Hospital, Shijiazhuang, Hebei, China
194 rdf:type schema:Organization
 




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