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
  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:


Further study details as provided by Nycomed:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Nycomed
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:
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 October 19, 2014