CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 58 enrolled
Drug / intervention
Dulaglutide +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/NCT01667900
NCT01667900Phase 1Completed
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Pharmacokinetics of a Single Dulaglutide Dose in Healthy Chinese Subjects and of Multiple Dulaglutide Doses in Chinese Patients With T2DM

Eli Lilly and Company·interventional·Posted Aug 17, 2012·Updated Mar 7, 2016

In Brief

A Phase 1 clinical trial evaluating Dulaglutide and Placebo for Diabetes Mellitus, Type 2 and Healthy Volunteers. Completed, enrolled 58 participants across 1 site.

Detailed Summary

This is a study of dulaglutide in Chinese participants. The purpose of the study is to determine how the body processes dulaglutide and how dulaglutide affects the body. This study has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of 3 study periods. There is a minimum 28-day washout between periods. Part A will last approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks. Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Healthy Volunteers
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

Dulaglutidedrug

Placebodrug

Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.