drugset / Trial / NCT01664624

Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

NCT01664624 ↗

Phase 1 Completed 40 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-07
Primary completion
2012-11
Completion
2012-11

Outcome

Missed primary endpoint

registry Roflumilast + Alogliptin vs Alogliptin Alone; p = 0.388; LS Mean Difference -5.1 (95% CI -16.9 to 6.7); ANCOVA NCT01664624 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Alogliptin Unknown 25 mg Oral
Comparator Exenatide Peptide 5 ug Subcutaneous
Subject Roflumilast Small molecule 500 ug Oral