A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

Summary

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.

Timeline

Start

2012-07

Primary completion

2014-08

Completion

2014-08

Outcome

Met primary endpoint

registry analysis (unspecified test); 1.5 mg Dulaglutide vs Glimepiride; p <0.001; Mean Difference (Net) -0.58 (95% CI -0.76 to -0.39); Mixed Models Analysis NCT01644500 ↗

registry analysis (unspecified test); 0.75 mg Dulaglutide vs Glimepiride; p <0.001; Mean Difference (Net) -0.32 (95% CI -0.50 to -0.13); Mixed Models Analysis NCT01644500 ↗

Publications

• Kuang J, Zhu J, Liu S, Li Q. Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies. Diabetes Ther. 2020 Oct;11(10):2329-2339. doi: 10.1007/s13300-020-00910-1. Epub 2020 Aug 28.
• Guo L, Zhang B, Hou J, Zhou Z. Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials. Diabetes Ther. 2020 Aug;11(8):1821-1833. doi: 10.1007/s13300-020-00869-z. Epub 2020 Jul 4.
• Yu M, Yuan GY, Zhang B, Wu HY, Lv XF. Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis. Diabetes Ther. 2020 May;11(5):1147-1159. doi: 10.1007/s13300-020-00804-2. Epub 2020 Apr 10.
• Li YM, Zhang LH, Li XJ, Zhang B, Hou JN, Tong NW. Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naive Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1. Diabetes Ther. 2020 May;11(5):1077-1090. doi: 10.1007/s13300-020-00799-w. Epub 2020 Mar 26.
• Li H, Xu X, Wang J, Kong X, Chen M, Jing T, Zhang Z, Yin G, Liu X, Hu Y, Ye L, Su X, Ma J. A Randomized Study to Compare the Effects of Once-Weekly Dulaglutide Injection and Once-Daily Glimepiride on Glucose Fluctuation of Type 2 Diabetes Mellitus Patients: A 26-Week Follow-Up. J Diabetes Res. 2019 Apr 30;2019:6423987. doi: 10.1155/2019/6423987. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dulaglutide	Peptide	0.75 mg	Subcutaneous
Subject	Dulaglutide	Peptide	1.5 mg	Subcutaneous
Comparator	Glimepiride	Small molecule	—	Oral

Indications