CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 137 enrolled
Drug / intervention
exenatide +1 moredrug
Likely dose
Exenatide 5 mcg or 10 mcg subcutaneously twice daily; rosiglitazone 2 mg or 4 mg orally twice dailyAI-extracted
Key inclusion· 2
  • ✓HbA1c between 6.8% and 10.0%
  • ✓BMI between 25 and 40 kg/m²
Key exclusion· 8
  • ✕Prior exenatide, pramlintide, GLP-1 analogs, or DPP-IV inhibitors
  • ✕Thiazolidinedione use within 5 months of screening
  • ✕Sulfonylurea within 3 months of screening
  • ✕Insulin for more than 1 week within 3 months prior to screening

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

Search/NCT00135330
NCT00135330Phase 3Completed
CompareCT.gov

An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

AstraZeneca·interventional·Posted Aug 26, 2005·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide and rosiglitazone for Diabetes Mellitus, Type 2. Completed, enrolled 137 participants across 19 sites.

Detailed Summary

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2005
Enrollment StartOct 1, 2005
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

exenatidedrug

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

rosiglitazonedrug

oral tablet, 2mg or 4mg, twice a day