The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus (AWARD-CHN1)

NCT01644500 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	COMPLETED
Enrolment	737
Start date	2012-07
Completion	2014-08

Conditions

• Type 2 Diabetes Mellitus

Interventions

• Dulaglutide
• Glimepiride
• Placebo as Capsules
• Placebo as SC Injection

Primary outcomes

• Change From Baseline in 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 Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.

Countries

China, South Korea, Taiwan