A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus

NCT01027871 Phase 2 COMPLETED Results posted

Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	COMPLETED
Enrolment	289
Start date	2010-01
Completion	2011-01

Conditions

• Diabetes Mellitus, Type 2

Interventions

• LY2605541
• insulin glargine

Primary outcomes

• Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles — Week 12
  8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c \[HbA1c\] group); visit; visit and treatment interaction; random effect for participant.

Countries

United States, Australia, Hungary, Poland, Puerto Rico, Romania, Russia, Spain