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NCT01664624 · ClinicalTrials.gov registry record · Phase 1
Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01664624: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01664624 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01664624, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of roflumilast plus alogliptin on glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.
Primary Outcome
The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.
Interventions
- DRUG Roflumilast
- DRUG Exenatide
- DRUG Alogliptin
- DRUG Placebo to roflumilast
- DRUG Placebo to alogliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01664624 record still lists
NCT01664624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 5 interventions - of which Roflumilast is the first listed.
NCT01664624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01664624 about?
NCT01664624 is a clinical study titled "Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes". The purpose of this study is to assess the effect of roflumilast plus alogliptin on glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.
What is the current status of trial NCT01664624?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01664624?
The interventions under investigation include: Roflumilast (DRUG), Exenatide (DRUG), Alogliptin (DRUG), Placebo to roflumilast (DRUG), Placebo to alogliptin (DRUG).
Who is sponsoring clinical trial NCT01664624?
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 NCT01664624's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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