CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 494 enrolled
Drug / intervention
exenatide twice daily (BID) +1 moredrug
Likely dose
exenatide twice daily (BID) 5 mcgfrom 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/NCT00434954
NCT00434954Phase 3Completed
CompareCT.gov

Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

AstraZeneca·interventional·Posted Feb 14, 2007·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide twice daily (BID) and premixed insulin aspart twice daily (BID) for Type 2 Diabetes Mellitus. Completed, enrolled 494 participants across 39 sites.

Detailed Summary

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesGermany
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.4 years ago

Interventions

exenatide twice daily (BID)drug

subcutaneous injection (5 mcg or 10 mcg), twice a day

premixed insulin aspart twice daily (BID)drug

subcutaneous injection (titrated appropriately), twice a day