The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea (AWARD-CHN2)

NCT01648582 Phase 3 COMPLETED Results posted

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	COMPLETED
Enrolment	774
Start date	2012-07
Completion	2014-12

Conditions

• Type 2 Diabetes Mellitus

Interventions

• Dulaglutide
• Insulin glargine
• Metformin
• Sulfonylureas

Primary outcomes

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks — Baseline, 26 Weeks
  HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.

Countries

China, Mexico, Russia, South Korea