A randomized, double-blind, placebo-controlled, Phase 2b study of LY2409021 in patients with type 2 diabetes mellitus - ND

• Conditions: MedDRA version: 13.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Type 2 Mellitus Diabetes

• Registration Number: EUCTR2010-023231-42-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-13
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Male or female patients not of child-bearing potential with type 2 diabetes mellitus (T2DM) between 18 and 70
years old, inclusive, treated with diet and exercise alone or in combination with metformin (at least 1000 mg/day
stable and unchanged for at least 3 months prior to screening) are eligible for this study.
Other criteria for inclusion include:
? HbA1c value between 7.0% and 10.5%, inclusive
? body mass index (BMI) between 25 to 45 kg/m2, inclusive
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

Main criteria for exclusion include:
? clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase
[AST] or alanine aminotransferase [ALT]) >2.5 times upper limit of normal (ULN) as determined by the
central laboratory at screening
? current or previous diagnosis of Gilbert’s disease
? previous diagnosis of hepatitis B or a current positive hepatitis B surface antigen, even if LFTs are <2.5
times ULN
? previous diagnosis of hepatitis C or a current positive hepatitis C surface viral antibody, even if LFTs are
<2.5 times ULN

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified