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)

October 24, 2016 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

487

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Roflumilast
500µg, once daily
Active Comparator: Roflumilast
500µg, once daily
Drug: Roflumilast
500µg, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)
Time Frame: Baseline to last visit
Baseline to last visit

Secondary Outcome Measures

Outcome Measure
Measure Description
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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