A Study in Type 2 Diabetes

Conditions: Type 2 Diabetes
MedDRA version: 14.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

Registration Number: EUCTR2011-000842-39-IT

Lead Sponsor: ELI LILLY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1516

Inclusion Criteria

T2DM (per World Health Organization [WHO] Classification of Diabetes not treated with insulin [2] Age 18 years of age or older [3] Duration of diabetes = 1 year
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 379

Exclusion Criteria

Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions, and up to a maximum of 4 continuous weeks. [13] Concomitant medications: Rosiglitazone, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide onceweekly or liraglutide) used concurrently or within 3 months prior to screening. [14] Local OAM restrictions: for patients on OAMs, restrictions for cardiac, renal and hepatic diseases, local product regulations must apply [15] Prescription weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-thecounter medications to promote weight loss. [16] Severe hypoglycemia history

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate that LY2605541 is noninferior to insulin glargine for the change in HbA1c from baseline to 26 weeks of treatment in insulin naive patients with T2DM;Secondary Objective: Gated: 1. Nocturnal hypoglycemia rate during the first 26 weeks of treatment 2. Proportion of patients with HbA1c <7.0% at 26 weeks and no nocturnal hypoglycemia during the first 26 weeks of treatment 3. HbA1c change from baseline after 26 weeks of treatment 4. Proportion of patients with HbA1c <7.0% after 26 weeks of treatment 5. Total hypoglycemia rate during the first 26 weeks of treatment 6. Fasting serum glucose (FSG) by laboratory measurement after 26 weeks of treatment;Primary end point(s): A change of HbA1c from baseline to 26 weeks that is not inferior to glargine.;Timepoint(s) of evaluation of this end point: 26 weeks

Secondary Outcome Measures