Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study

Sponsor
AstraZeneca
Study ID
NCT01140542
Phase
PHASE2
Status
Completed

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
35 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a proof of concept study to confirm in a standardized manner the therapeutic efficacy of roflumilast in type 2 diabetes mellitus patients.

Key Dates

Start date
Aug 31, 2006
Status verified
Sep 2016
Primary completion
Nov 30, 2007
Completion
Mar 31, 2008

Study Design

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

Arms

  • Active Comparator: Roflumilast
    500µg, once daily
  • Placebo Comparator: Placebo

Primary Outcome Measure

Mean change in HbA1c [percent] from baseline to the last study visit (Vlast) [ Time Frame: Baseline to last visit ]

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