Last reviewed · How we verify
A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 1 Diabetes Mellitus
Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 138 |
| Start date | 2010-01 |
| Completion | 2011-01 |
Conditions
- Diabetes Mellitus, Type 1
Interventions
- LY2605541
- Insulin glargine
Primary outcomes
- Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles — Week 8 of each treatment period
It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday \& evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin \[HbA1c\] group); visit; visit and treatment interaction; a random effect for participant.
Countries
United States, Israel