Conditions: Type 2 Diabetes
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:
This is a study to evaluate the antiglycemic efficacy and safety of roflumilast + alogliptin compared to alogliptin alone and roflumilast alone; it will also include an open-label exenatide treatment arm as a control. The antiglycemic efficacy of the combination will be evaluated through the measurement of postprandial active GLP-1 level, ß cell secretion activity (via the measurement of C-peptide and insulin levels), appetite sensations (as assessed by VAS) and glycemic control as assessed by a continuous glucose monitoring system (CGMS).

Arms:
arm 1: Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days. arm 2: Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days. arm 3: Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days. arm 4: Exenatide 5 μg subcutaneous injection twice a day for 11 days.

Interventions: intervention 1: Roflumilast intervention 2: Alogliptin intervention 3: Exenatide intervention 4: Placebo to roflumilast intervention 5: Placebo to alogliptin
Intervention descriptions: intervention 1: Roflumilast tablets intervention 2: Alogliptin tablets intervention 3: Exenatide solution intervention 4: Placebo-matching roflumilast tablets intervention 5: Placebo-matching alogliptin tablets

Protocol document: