At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
exenatide once weekly +3 moredrug
Likely dose
exenatide once weekly 2 mgfrom 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.
A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.
In Brief
A Phase 2 clinical trial evaluating exenatide once weekly and exenatide once monthly suspension for Type 2 Diabetes. Completed, enrolled 121 participants across 2 sites.
Detailed Summary
The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
CollaboratorsEli Lilly and Company
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionDec 2010
TodayJul 2026
First PostedApr 15, 2010
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.2 years ago
Interventions
exenatide once weeklydrug
subcutaneous injection, 2 mg, once a week
exenatide once monthly suspensiondrug
subcutaneous injection, low dose, once a month
exenatide once monthly suspensiondrug
subcutaneous injection, medium dose, once a month
exenatide once monthly suspensiondrug
subcutaneous injection, high dose, once a month