A study to compare a new drug for Type 2 Diabetes to placebo (a placebo looks like the study drug but has no medicine) and to a treatment already available for Type 2 Diabetes.

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 18.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-003552-21-PL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-23
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Men or women aged 18 to 80 years with T2DM. Eligibility criteria include: HbA1c =7.0% and =10.5% at screening and treated with diet and exercise alone or on a stable dose of metformin (=1000 mg/day) for 3 months prior to screening. BMI =23 and =45 kg/m2 at screening.
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 337
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

Patients are excluded from participation if they; are women of child bearing potential; used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months; have used insulin for diabetic control for more than 6 consecutive days within the prior year; and if they have impaired renal function (serum creatinine >124 µmol/L [1.4 mg/dL] in women, >133 µmol/L [1.5 mg/dL] in men).

Study & Design

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