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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: A Takeda Company
ClinicalTrials.gov Identifier:
NCT01140542
First received: June 8, 2010
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
 Drug: Roflumilast
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Roflumilast
U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

Primary Outcome Measures:
  • Mean change in HbA1c [percent] from baseline to the last study visit (Vlast) [ Time Frame: Baseline to last visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 487
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roflumilast
500µg, once daily
 Drug: Roflumilast
500µg, once daily
Placebo Comparator: Placebo Drug: Roflumilast
500µg, once daily

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140542

Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Director: Medical Responsible Clincial Trial Operations
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT01140542     History of Changes
Other Study ID Numbers: BY217/M2-401
Study First Received: June 8, 2010
Last Updated: May 4, 2012
Health Authority: Mexico: Federal Commission for Protection Against Health Risks
Romania: National Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Ukraine: State Pharmacological Center - Ministry of Health
Chile: Ministerio de Salud Instituto de Salud Pública de Chile (ISPCH)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Nycomed: A Takeda Company:
Diabetes Mellitus Type 2
Roflumilast

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013