GLPwatch
A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
NCT01104701 · Completed
Last updated 2026-05-28This clinical trial tested a once-monthly injection of exenatide in adults with type 2 diabetes to see how it affects blood sugar levels over 20 weeks.
Status Completed The study has finished.
Phase Phase 2 Tests whether it works and watches safety in a moderate group.
Type Interventional (clinical trial)
Design Randomized, open-label (no blinding) treatment study
Participants 121 people
Who can join Ages 18+ · all sexes
Timeline Started 2010-05 · est. completion 2010-12
Where 2 sites · United States
What this study is testing ClinicalTrials.gov NCT01104701 ↗
Description as written by the study sponsor.
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.
Treatments tested
- exenatide once weekly Drug
subcutaneous injection, 2 mg, once a week
- exenatide once monthly suspension Drug
subcutaneous injection, low dose, once a month
- exenatide once monthly suspension Drug
subcutaneous injection, medium dose, once a month
- exenatide once monthly suspension Drug
subcutaneous injection, high dose, once a month
| Main thing measured | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population |
|---|---|
| Sponsor | AstraZeneca |
| Conditions studied | Type 2 Diabetes |
| GLP-1 drugs | exenatide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01104701 ↗