GLPwatch
Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
NCT01664624 · Completed
Last updated 2026-05-28This clinical trial tested whether combining roflumilast and alogliptin affects gut hormone levels in adults with type 2 diabetes.
Status Completed The study has finished.
Phase Phase 1 Checks safety and dosing in a small group.
Type Interventional (clinical trial)
Design Randomized, quadruple-blind treatment study
Participants 40 people
Who can join Ages 18–80 · all sexes
Timeline Started 2012-07 · est. completion 2012-11
Where 2 sites · United States
What this study is testing ClinicalTrials.gov NCT01664624 ↗
Description as written by the study sponsor.
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.
Treatments tested
- Roflumilast also known as Daxas, Daliresp Drug
Roflumilast tablets
- Alogliptin also known as Nesina Drug
Alogliptin tablets
- Exenatide also known as Byetta, Bydureon Drug
Exenatide solution
- Placebo to roflumilast Drug
Placebo-matching roflumilast tablets
- Placebo to alogliptin Drug
Placebo-matching alogliptin tablets
| Main thing measured | Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1 |
|---|---|
| Sponsor | AstraZeneca |
| Conditions studied | Type 2 Diabetes |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01664624 ↗