Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5438
Source ID: NCT01140542
Associated Drug: Roflumilast
Title: 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
Acronym: FORTUNA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Roflumilast
Outcome Measures: Primary: Mean change in HbA1c [percent] from baseline to the last study visit (Vlast), Baseline to last visit | Secondary: Mean change in HbA1c from baseline to each scheduled post-randomization visit|Mean change from baseline to each scheduled post-randomization visit and Vlast in blood parameters, blood parameters: serum lipids (high-density-lipoprotein-cholesterol \[HDL\], low-density-lipoprotein-cholesterol \[LDL\], and triglycerides \[TG\]), fasting plasma glucose (FPG), fructosamine, glycerol, free fatty acids \[FFA\], plasma insulin, fasting pro-insulin, cholesterol, c-reactive protein (CRP), interleukin-6 (IL-6), TNF-α, intercellular adhesion molecule 1 (ICAM-1), E-selectin, plasminogen activator inhibitor 1 (PAI-1), adiponectin, and leptin|Mean change from baseline to each scheduled post-randomization visit and Vlast based on a 5-hour period post meal area under the curve (AUC) for FFA, glycerol, glucose, glucagons, insulin, and C-peptide|Mean change in body weight, waist and hip circumference, waist to hip ratio, and body mass index (BMI) from baseline to each scheduled post-randomization visit and Vlast|Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 487
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-08
Completion Date: 2008-03
Results First Posted:
Last Update Posted: 2016-10-26
Locations:
URL: https://clinicaltrials.gov/show/NCT01140542