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

What Was Tested

This registered phase 1 trial tested Exenatide.

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.

It had four arms (groups): Roflumilast + alogliptin (experimental), Alogliptin alone (experimental), Roflumilast alone (experimental) and Exenatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Has an historical diagnosis of type 2 diabetes mellitus (T2DM) disease. Has a body mass index (BMI) of ≥23.0 kg/m\^2 and ≤45.0 kg/m\^2, at Screening. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

The full record lists 9 inclusion and 24 exclusion criteria; among the exclusions: has a history of type 1 diabetes; has a history of acute metabolic diabetic complications; has a history of diabetic gastroparesis or history of gastric bypass surgery.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-07 with completion listed for 2012-11.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1.

It also tracked 5 secondary outcomes, for example Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose, Change From Baseline in Postprandial AUC(0-8) of C-peptide, Change From Baseline in Postprandial AUC(0-8) of Insulin, Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation and Change From Baseline to Day 11 in 24-hour Average Plasma Glucose.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 40 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.