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)
- Conditions
- MedDRA version: 9.1Level: PTClassification code 10012607Type II Diabetes Mellitus
- Registration Number
- EUCTR2009-014803-30-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 837
Type 2 diabetes (based on the World Health Organization s [WHO] diagnostic criteria, Protocol Attachment GBDB.3) not optimally controlled with 1, 2, or 3 OAMs (at least 1 of which must be metformin or a sulfonylurea); [a] Visit 1 HbA1c ≥7% and ≤11%, if on OAM monotherapy for 3 months before screening; these patients must also be on the minimal required dose or higher at Visit 1 (metformin 1500 mg; glimepiride 4 mg; for other sulfonylureas, the minimal required dose must be 50% of the recommended maximum daily dose (Table 9.2, Section 9.7.1) (Mudaliar et al 2003); OR [b] Visit 1 HbA1c ≥7 and ≤10%, if on 2 or 3 antihyperglycemic medications for 3 months before screening; other allowed OAMs are DPP-IV inhibitors, thiazolidinediones, glinides and alpha-glucosidase inhibitors;
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
[10] Type 1 diabetes mellitus; [11] Visit 4 HbA1c ≤6.5%; [12] Treated chronically with insulin therapy for the treatment of diabetes at any time in the past (patients who have been treated with insulin for the short-term management of acute conditions that occurred more than 3 months prior to Visit 1 are allowed to participate), or have received therapy with any marketed glucagon-like peptide 1 (GLP-1) receptor agonists (for example, exenatide or liraglutide) in the last 3 months prior to Visit 1;
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