CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
exenatide +1 moredrug
Likely dose
exenatide 5mcgfrom 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/NCT00667732
NCT00667732Phase 4Completed

Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes

Oregon Health and Science University·interventional·Posted Apr 28, 2008·Updated Feb 6, 2013

In Brief

A Phase 4 clinical trial evaluating exenatide and placebo for Type 2 Diabetes. Completed, enrolled 41 participants across 3 sites.

Detailed Summary

This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics. The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen. There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2008
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.2 years ago

Interventions

exenatidedrug

5mcg twice a day, increasing to 10mcg twice a day for 24 weeks

placebodrug

5mcg twice a day, increased to 10mcg twice a day for 24 weeks