A study in Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, type 2
MedDRA version: 14.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2010-019223-55-SE

Lead Sponsor: Eli Lilly & Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 837

Inclusion Criteria

See protocol for details.
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 837
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

See protocol for details.

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 1.5 mg LY2189265, to that of insulin glargine (treated-to-target) on HbA1c at 26 weeks (change from baseline) in patients with type 2 diabetes who are treated in combination with prandial insulin lispro, using a non-inferiority analysis.;Secondary Objective: The following key secondary objectives will compare glycemic control (change from baseline) between LY2189265 (1.5 mg and 0.75 mg) and insulin glargine:<br>• To demonstrate that 0.75 mg LY2189265 is noninferior to insulin glargine<br>at 26 weeks.<br>• To demonstrate that 1.5 mg LY2189265 is superior to insulin glargine at<br>26 weeks.<br>• To demonstrate that 0.75 mg LY2189265 is superior to insulin glargine at<br>26 weeks.<br><br>See protocol for additional secondary objectives.;Primary end point(s): The primary efficacy measurement in this study is HbA1c change from baseline at<br>26 weeks.;Timepoint(s) of evaluation of this end point: 26 weeks

Secondary Outcome Measures