A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients with Type 2 Diabetes on Stable Doses of Metformin and Glimepiride(AWARD-2: Assessment of Weekly AdministRation of LY2189265 in Diabetes-2) - GBDB
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 12.0Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2009-014803-30-HU
- Lead Sponsor
- Eli Lilly & Company - Indianapolis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 837
Men and non-pregnant women aged =18 years with type 2 diabetes mellitus who have been treated with 1 oral antihyperglycemic medication, with a screening HbA1c =7.0% and 11% or patients who have been treated with 2 or 3 oral antihyperglycemic medications with a screening HbA1c =7.0% and 10%.
See protocol for full inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with type 1 diabetes mellitus; with HbA1c =6.5%; patients treated chronically with insulin therapy for the treatment of diabetes at any time in the past.
See protocol for full exclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method