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

Part of paid clinical trials in Chula Vista, California.

Sponsor
AstraZeneca
Study ID
NCT01664624
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast tablets
  • Alogliptin — DRUG
    Alogliptin tablets
  • Exenatide — DRUG
    Exenatide solution
  • Placebo to roflumilast — DRUG
    Placebo-matching roflumilast tablets
  • Placebo to alogliptin — DRUG
    Placebo-matching alogliptin tablets

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Sep 2016
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast + alogliptin
    Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
  • Experimental: Alogliptin alone
    Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
  • Experimental: Roflumilast alone
    Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
  • Active Comparator: Exenatide
    Exenatide 5 μg subcutaneous injection twice a day for 11 days.

Primary Outcome Measure

Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1 [ Time Frame: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal). ]

Locations (2)

FacilityCityStateZIPSite coordinators
-Chula VistaCalifornia--
-OrlandoFlorida--

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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