CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 505 enrolled
Drug / intervention
exenatide +1 moredrug
Likely dose
Exenatide 5 mcg subcutaneously twice daily for 4 weeks, then 10 mcg twice daily for 48 weeksAI-extracted
Key inclusion· 3
  • ✓Stable dose of metformin ≥1500 mg/day plus optimally effective sulfonylurea dose for ≥3 months before screening
  • ✓HbA1c between 7.0% and 11.0% inclusive
  • ✓Body mass index >25 kg/m² and <40 kg/m²
Key exclusion· 13
  • ✕Prior treatment with exenatide or any GLP-1 analog in any study
  • ✕Greater than three episodes of severe hypoglycemia within 6 months prior to screening
  • ✕Less than 5 years of remission history from any malignancy (except skin/cervical/prostate cancers)
  • ✕NYHA Class III or IV cardiac disease

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

Search/NCT00082407
NCT00082407Phase 3Completed
CompareCT.gov

Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

AstraZeneca·interventional·Posted May 10, 2004·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide and biphasic insulin aspart for Diabetes Mellitus, Type 2. Completed, enrolled 505 participants across 69 sites in 12 countries.

Detailed Summary

This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCroatia, Germany, Greece, Italy, Netherlands, Portugal, Romania, Russia, Slovenia, Spain, Taiwan, United Kingdom
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 10, 2004
Enrollment StartNov 1, 2003
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 22.1 years ago

Interventions

exenatidedrug

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks

biphasic insulin aspartdrug

subcutaneous injection, twice daily; titration to target blood glucose level