At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Roflumilast +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Randomized, Double-Blind, Active Comparator (Open-Label Exenatide) Controlled Study to Evaluate the Effect of Roflumilast Plus Alogliptin on Postprandial Active GLP-1 Level and 24-hour Glucose Level in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on a Stable Dose of Metformin
In Brief
A Phase 1 clinical trial evaluating Roflumilast, Alogliptin, and 3 other interventions for Type 2 Diabetes. Completed, enrolled 40 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedAug 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedAug 14, 2012
Enrollment StartJul 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.9 years ago
Interventions
Roflumilastdrug
Roflumilast tablets
Alogliptindrug
Alogliptin tablets
Exenatidedrug
Exenatide solution
Placebo to roflumilastdrug
Placebo-matching roflumilast tablets
Placebo to alogliptindrug
Placebo-matching alogliptin tablets