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NCT01652729 · ClinicalTrials.gov registry record · Phase 3
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study of Diabetes Type 2, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
- 20
- Study locations
NCT01652729: Completed Phase 3 study of Diabetes Type 2, sponsored by AstraZeneca.
NCT01652729 is a Phase 3 study of Diabetes Type 2 that has completed, run by AstraZeneca. The registered enrollment target is 365 participants, below the 652-participant average among 24 other Diabetes Type 2 trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652729, a Phase 3 study of Diabetes Type 2, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.
Primary Outcome
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sitagliptin
- DRUG Exenatide once weekly suspension
Study Locations (20)
California
- Research Site - Beverly Hills
- Research Site - Buena Park
- Research Site - Chino
- Research Site - Chula Vista
- Research Site - Encinitas
- Research Site - Greenbrae
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - North Hollywood
- Research Site - Walnut Creek
- Research Site - West Hills
Florida
- Research Site - Boca Raton
- Research Site - Hialeah
- Research Site - Miami
- Research Site - Miami
- Research Site - Miami
Alabama
- Research Site - Birmingham
- Research Site - Huntsville
Arizona
- Research Site - Phoenix
- Research Site - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01652729 record still lists
NCT01652729 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 24 other Diabetes Type 2 trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Diabetes Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01652729 names 20 study sites across 4 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01652729 about?
NCT01652729 is a clinical study titled "Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus". To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.
What is the current status of trial NCT01652729?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2013-02. Estimated completion is 2014-04.
What conditions does trial NCT01652729 study?
This clinical trial studies the following conditions: Diabetes Type 2.
What interventions are being tested in trial NCT01652729?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG), Exenatide once weekly suspension (DRUG).
Who is sponsoring clinical trial NCT01652729?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01652729 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01652729's enrollment target sits among peer trials
365 9th of 24 higher than 16 of 24 other Diabetes Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Type 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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