CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 551 enrolled
Drug / intervention
Exenatide (AC2993) +1 moredrug
Likely dose
Exenatide 5 mcg subcutaneously twice daily for 4 weeks, then 10 mcg twice daily for 22 weeksAI-extracted
Key inclusion· 4
  • ✓Stable dose of metformin (1500-2550 mg/day immediate-release or 1500-2000 mg/day extended-release) PLUS optimally effective sulfonylurea dose for at least 3 months before screening, OR fixed-dose sulfonylurea/metformin combination with same dosing requirements
  • ✓HbA1c between 7.0% and 10.0%, inclusive
  • ✓Stable body weight, not varying by more than 10% for at least 3 months before screening
  • ✓Female patients of childbearing potential must not be breastfeeding; use contraception if not surgically sterilized and between menarche and 1-year postmenopause
Key exclusion· 9
  • ✕Prior participation in any study using AC2993 or GLP-1 analogs
  • ✕Greater than three episodes of severe hypoglycemia within 6 months before screening
  • ✕Current or recent malignancy therapy, except basal cell or squamous cell skin cancer
  • ✕New York Heart Association Class III or IV cardiac disease

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

Search/NCT00082381
NCT00082381Phase 3Completed
CompareCT.gov

Effect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

AstraZeneca·interventional·Posted May 11, 2004·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating Exenatide (AC2993) and Insulin glargine for Diabetes Mellitus, Type 2. Completed, enrolled 551 participants across 91 sites in 13 countries.

Detailed Summary

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Belgium, Brazil, Finland, Germany, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Sweden, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2004
Enrollment StartJun 1, 2003
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 22.1 years ago

Interventions

Exenatide (AC2993)drug

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks

Insulin glarginedrug

subcutaneous injection, once daily; forced titration to target blood glucose level