CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 247 enrolled
Drug / intervention
LY2428757 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00804986
NCT00804986Phase 2Completed

A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company·interventional·Posted Dec 9, 2008·Updated Jul 14, 2011

In Brief

A Phase 2 clinical trial evaluating LY2428757 and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 247 participants across 60 sites in 11 countries.

Detailed Summary

A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, India, Mexico, Puerto Rico, Romania, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2008
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.6 years ago

Interventions

LY2428757drug

Once weekly for 12 weeks as a subcutaneous injection.

Placebodrug

1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.