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NCT01104701 · ClinicalTrials.gov registry record · Phase 2
A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
NCT01104701: Completed Phase 2 study, sponsored by AstraZeneca.
NCT01104701 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01104701, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
Study 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.
Primary Outcome
HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Interventions
- DRUG exenatide once weekly
- DRUG exenatide once monthly suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT01104701 record still lists
NCT01104701 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which exenatide once weekly is the first listed.
NCT01104701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01104701 about?
NCT01104701 is a clinical study titled "A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension". 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.
What is the current status of trial NCT01104701?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2010-05. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01104701?
The interventions under investigation include: exenatide once weekly (DRUG), exenatide once monthly suspension (DRUG).
Who is sponsoring clinical trial NCT01104701?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01104701's enrollment target sits among peer trials
121 567th of 2000 higher than 1,432 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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