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: MedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitus
Type 2 Diabetes Mellitus

Registration Number: EUCTR2009-014841-10-SK

Lead Sponsor: Eli Lilly & Company - Indianapolis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 753

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
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The following key secondary objectives will compare glycemic control (as measured by change in HbA1c from baseline) between LY2189265 (1.5 mg and 0.75 mg) and metformin:<br>• To demonstrate that LY2189265 1.5 mg is superior to metformin at 26 weeks.<br>• To demonstrate that LY2189265 0.75 mg is noninferior to metformin at 26 weeks.<br>• To demonstrate that LY2189265 0.75 mg is superior to metformin at 26 weeks.<br><br>See protocol for list of additional secondary objectives.;Main Objective: The primary objective is to demonstrate that once-weekly LY2189265 (1.5 mg) injected subcutaneously, is non-inferior to metformin on HbA1c change from baseline at 6 months in patients with type 2 diabetes mellitus.;Primary end point(s): The endpoint for the primary analysis is defined as the change from baseline in HbA1c at 26 weeks.

Secondary Outcome Measures