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NCT Number: NCT01140542

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roflumilast

Drug

500µg, once daily

Primary outcomes

  1. Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)

    Time frame: Baseline to last visit

Secondary outcomes

  1. Mean change in HbA1c from baseline to each scheduled post-randomization visit

  2. 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

  3. 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

  4. 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

  5. Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: FORTUNA

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 9, 2010
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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