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 - FORTUNA
- Conditions
- Diabetes mellitus type 2MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2005-005702-23-DE
- Lead Sponsor
- ycomed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 190
· Given written informed consent
· Age > 35 and < or = 70 years
· Patients with diagnosis of type 2 diabetes according to ADA criteria (American Diabetic Association) and inadequately controlled on diet and exercise alone.
· HbA1c at baseline: > or = 7.5 – 8.5 %
· BMI between > or = 26 and < or =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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
· Patients diagnosed with type-1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
· Patients diagnosed with a heamoglobinopathies, haemolytic anaemia or other diseases which interfere with HbA1c measurement
· Non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidysm
· Reported gain or loss of more than 5% of body weight within the last 2 month 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)
· Known infection with HIV, active hepatitis and/or active liver disease or unexplained elevations in ALT or AST (greater than 3X above the upper limit of normal for ALT or AST confirmed with repeat testing)
· History of clinically relevant diseases of the liver, kidney (including serum creatinine greater than 2.0 mg/dL) or gastrointestinal systems
· Diagnosis or history of cancer (other than basal cell carcinoma) within 5 years prior to study start
· Clinically significant cardial abnormalities (diagnosed clinically or by x-ray / ECG) that are not related to type 2 diabetes mellitus and that require further evaluation
· Diagnosis or history of stroke, myocardial infarct, chronic stable and unstable angina pectoris, ventricular arrhythmia, symptomatic congestive heart failure [NYHA III or IV) within 5 years prior to study start
· Uncontrolled hypertension, defined as blood pressure > 160/90 mmHg
· Presence or history of psychosis or psychotic disorders
· Suspected hypersensitivity to the study medication
· Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
· Female patients of childbearing potential (< 2 years postmenopausal or not sugically sterile), not using and not willing to continue using one of the following highly effective means of birth control with failure rates of less than 1% per year for > 30 days prior to enrollment, for the duration of the study, and for at least 30 days following the last dose of study medication:
- Combined oral contraceptives
- Approved implantable or injectable contraceptives
- Intrauterine contraceptives
In case none of the above mentioned contraceptive methods complying with the note for guidance CPMP/ICH/286/95 (modification) can be tolerated, the decision on an appropriate contraceptive method should be taken based on the expert advise of an obstetrician/gynecologist.
· Participation in another study (use of investigational product) within 30 days preceding the baseline visit V0 or re-entry of patients already enrolled in this trial.
· Participation in a clinical study with study medication for weight loss or type 2 diabetes
· Suspected inability or unwillingness to comply with study procedures
· History or presence of alcohol or drug dependence within 7 years prior to Screening
· Inability to follow study procedures due to e.g. language problems
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method