The Impact of LY2189265 versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus(AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3) - GBDC
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2009-014841-10-FI
- Lead Sponsor
- Eli Lilly & Company - Indianapolis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 753
Patients diagnosed with type 2 diabetes for =3 months and =5 years, with a screening HbA1c =6.5% to =9.5%, and are
1) treatment naïve
2) not optimally treated with diet and exercise alone, and/or
3) on 1 oral antihyperglycemic medication.
Patients on oral antihyperglycemic medication (OAM) monotherapy must
be on a dose =50% of the recommended maximum daily dose (per the local label) at Visit 1 for =3 months.
See protocol for full details of 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 who have type 1 diabetes; or who have been treated chronically with insulin therapy for the treatment of diabetes at any time in the past.
See protocol for full details of 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