CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,036 enrolled
Drug / intervention
exenatide +3 moredrug
Likely dose
exenatide 5mcgfrom 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/NCT00960661
NCT00960661Phase 3Completed
CompareCT.gov

A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

AstraZeneca·interventional·Posted Aug 18, 2009·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide, insulin lispro, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,036 participants across 95 sites in 18 countries.

Detailed Summary

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Belgium, Estonia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, United Kingdom
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.9 years ago

Interventions

exenatidedrug

subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day

insulin lisprodrug

titrated based on pre-meal glucose level; three times a day

Metformindrug

Insulin/ Glarginedrug