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 (FORTUNA)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT01140542
First received: June 8, 2010
Last updated: May 4, 2012
Last verified: May 2012

June 8, 2010
May 4, 2012
August 2006
November 2007   (final data collection date for primary outcome measure)
Mean change in HbA1c [percent] from baseline to the last study visit (Vlast) [ Time Frame: Baseline to last visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140542 on ClinicalTrials.gov Archive Site
  • Mean change in HbA1c from baseline to each scheduled post-randomization visit [ Designated as safety issue: No ]
  • Mean change from baseline to each scheduled post-randomization visit and Vlast in blood parameters [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Phase IIb, Proof of Concept Clinical Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
Drug: Roflumilast
500µg, once daily
  • Active Comparator: Roflumilast
    500µg, once daily
    Intervention: Drug: Roflumilast
  • Placebo Comparator: Placebo
    Intervention: Drug: Roflumilast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
March 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • given written informed consent
  • patients with diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria and inadequately controlled on diet and exercise alone
  • HbA1c at baseline: ≥7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania)
  • BMI between ≥26 and ≤35 kg/m2
  • willingness of patient to check his/her blood glucose with equipment provided by the sponsor during the treatment phase in case of hypo-/hyperglycemia episodes
  • willingness to adhere to the physician's advise to comply with diet and exercise

Main Exclusion Criteria:

  • patients diagnosed with type 1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
  • patients diagnosed with hemoglobinopathies, hemolytic anemia or other diseases which interfere with HbA1c measurement
  • non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidism
  • reported gain or loss of more than 5 percent of body weight within the last 2 months prior to V0
  • treatment with any diabetes medication prior to V0
  • treatment with any weight-loss medication within 3 months prior to V0
  • treatment with any not allowed medication or nutrition additives
  • clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
  • clinically significant cardiac abnormalities (diagnosed clinically, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation
  • participation in a clinical study with study medication for weight loss or type 2 diabetes

Patients were randomized after 2 weeks of the baseline period, if the following criteria were fulfilled:

  • judged to be clinically stable
  • tablet compliance ≥80 percent and ≤125 percent
  • HbA1c in the range of 7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania) tested at V0 by the central laboratory
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01140542
BY217/M2-401
Not Provided
Nycomed, Clinical Trial Operations
Nycomed
Not Provided
Study Director: Medical Responsible Clincial Trial Operations
Nycomed
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP