EUCTR2009-014841-10-CZActive, not recruitingNot Applicable
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) - AWARD-3: Assessment of Weekly Administration of LY2189265 in Diabetes
Eli Lilly & Company0 sites753 target enrollmentStarted: May 25, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 753
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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 753
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A study in patients with Type 2 Diabetes mellitusType 2 Diabetes MellitusEUCTR2009-014841-10-GBEli Lilly & Company - Indianapolis753
Active, not recruiting
Not Applicable
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) - GBDCType 2 Diabetes MellitusEUCTR2009-014841-10-SKEli Lilly & Company - Indianapolis753
Active, not recruiting
Not Applicable
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) - GBDCType 2 Diabetes MellitusEUCTR2009-014841-10-FIEli Lilly & Company - Indianapolis753
Active, not recruiting
Phase 1
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) - GBDCMedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitusType 2 Diabetes MellitusEUCTR2009-014841-10-FREli Lilly & Company - Indianapolis753
Active, not recruiting
Not Applicable
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) - GBDCMedDRA version: 13.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2009-014841-10-DEEli Lilly & Company - Indianapolis753