Diabetes mellitus type 2 MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Nycomed GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Given written informed consent · Age > 35 and or = 7.5 – 8.5 % · BMI between > or = 26 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · 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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · To investigate and compare the effect of 500µg roflumilast once daily versus placebo once daily over 12 weeks on HbA1c in patients with diabetes mellitus type 2. ·To investigate and compare the safety and tolerability of roflumilast in patients with diabetes mellitus type 2 ;Secondary Objective: ;Primary end point(s): Efficacy: Primary variable: · mean changes in HbA1c from baseline to endpoint/last value. Secondary variables: · mean changes in HbA1c from baseline to all scheduled post-randomization timepoints. · mean changes in FFA, glycerol, glucose, glucagons, insulin, C-peptide after a fixed meal measured over a time course to be followed over 5 hrs, with measurements each 30 min. · mean changes in body weight, waist and hip measurements data, BMI · onset of action (FPG as relevant parameter) · mean changes in serum lipids (HDL, LDL,TGs), fructosamine, glycerol, free fatty acids and plasma insulin, CRP, IL-6, TNF-a, ICAM-1, E-selectin, PAI-1, adiponectin, leptine, Safety: · Incidence of hypo- and hyperglycemic episodes. · Adverse events, · Changes in laboratory values, · Changes in physical examination findings including electrocardiograms (ECG [PR, QRS, QT intervals], · Changes in vital signs blood pressure (BP) and heart rate (HR) | — |
Countries
Germany
Outcome results
None listed