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

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 12.0Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2009-014803-30-FR
• Lead Sponsor: Eli Lilly & Company - Indianapolis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-14
• Study Completion: 2012-11-23
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 837

Inclusion Criteria

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

Exclusion Criteria

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
Main Objective: To compare the effect of once-weekly LY2189265 1.5 mg, injected subcutaneously, to that of insulin glargine (titrated-to-target) on HbA1c at 52 weeks (change from baseline) in patients with type 2 diabetes mellitus who are taking metformin and glimepiride.;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 insulin glargine:<br>- To demonstrate that LY2189265 0.75 mg is noninferior to insulin glargine at 52 weeks.<br>- To demonstrate that LY2189265 1.5 mg is superior to insulin glargine at 52 weeks.<br>- To demonstrate that LY2189265 0.75 mg is superior to insulin glargine at 52 weeks.<br><br>For additional secondary objectives, see protocol.;Primary end point(s): The primary efficacy measurement in this study is change in HbA1c from baseline to 52 weeks