At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 69 enrolled
Drug / intervention
exenatide +2 moredrug
Likely dose
Exenatide subcutaneous injection, titrated up to maximum 20 mcg three times daily; Insulin glargine subcutaneous injection once daily, titrated as necessaryAI-extracted
Key inclusion· 4
- ✓Type 2 diabetes diagnosis, otherwise healthy
- ✓HbA1c between 6.6% and 9.5%
- ✓BMI 25–40 kg/m²
- ✓On stable metformin dose for ≥2 months before screening
Key exclusion· 3
- ✕Previous participation in exenatide study
- ✕Oral anti-diabetic medications other than metformin within 2 months of screening (or thiazolidinediones within 5 months)
- ✕Insulin treatment within 3 months of screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c
In Brief
A Phase 3 clinical trial evaluating exenatide, Insulin glargine, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 69 participants across 3 sites in 3 countries.
Detailed Summary
This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesFinland, Netherlands, Sweden
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedNov 2004
Primary CompletionDec 2009
TodayJul 2026
First PostedNov 25, 2004
Enrollment StartSep 1, 2004
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 21.6 years ago
Interventions
exenatidedrug
subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
Insulin glarginedrug
subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
Metformindrug
Patients usual dosage