Type 2 Diabetes Mellitus MedDRA version: 7 Level: low Classification code 10012613
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 30 to 75 years at the time of the screening examination • Type 2 diabetes mellitus patients treated with individual maximal tolerated daily dose of metformin monotherapy (minimal metformin daily dose more or equal than 1.5 g, maximum not higher than recommended in the label) for at least 3 months prior to screening • HbA1c more or equal than 7.0 % and = 10.0 % at screening • FPG > 126 mg/dL (7.0 mmol/L) and = 240 mg/dL (13.3 mmol/L) at screening • BMI = 45 kg/m2 at screening • Patients able and willing to give written informed consent and to comply with the requirements of the study 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
Exclusion criteria
Exclusion criteria: Patients meeting ANY of the following criteria are NOT eligible for this study. 1. Type 1 diabetes mellitus patients 2. Any severe hypoglycemic episodes within the last 3 months (requiring assistance by another person to recover) 3. Frequent (more than 3-4 episodes per week) moderate hypoglycemic episodes 4. History of ketoacidosis or lactic acidosis 5. Treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during the last 3 months 6. Treatment with insulin, except insulin use in emergency situations or during surgery for up to 7 days, but not within 3 months prior to the screening visit 7. Treatment with strong CYP450 3A4 inducers (such as rifampicin), or potent CYP450 3A4 inhibitors (such as atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole) 8. Systemic use of corticosteroids in the last 3 months 9. Contraindications to metformin, i.e. – Congestive heart failure requiring pharmacologic treatment – Respiratory insufficiency 10. Impaired liver function (ALAT, ASAT, total and direct bilirubin or alkaline phosphatase > 2.5x ULN) at screening 11. Severe and moderate renal impairment (creatinine clearance 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of the screening examination Canada only: Uncontrolled hypertension (SBP > 150 mmHg and/or DBP > 90 mmHg, despite treatment) at the time of the screening examination 13. Myocardial infarction or stroke within 6 months prior to the screening examination 14. Known proliferative diabetic retinopathy 15. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator. 16. Pregnant or lactating women 17. Female patients of childbearing potential who, with their partners refuse to use two forms of contraception (including 1 barrier method) from screening and for one month following last study drug intake 18. Participation in an investigational drug study within 90 days (3 months) prior to screening 19. Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination 20. Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the BID dose(s) of RO4389620 administered in combination with metformin, which when compared to placebo (metformin monotherapy) are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes;Secondary Objective: • To compare the effects of RO4389620 and placebo, when both taken in combination with metformin, on additional parameters of glycemic and lipid control • To evaluate the potential PK and/or PD interaction between metformin and RO4389620 and its major metabolites in patients on day 1 and after 4, 8 and 12 weeks. • To investigate, by a population analysis approach, the PK and the exposure-response relationship of RO4389620 in the target population, including the influence of covariates. • To explore whether a QD regimen could be equivalent to a BID regimen in terms of efficacy and safety ;Primary end point(s): HbA1c mean change from baseline at the end of the treatment period compared to placebo | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed