Type 2 diabetes MedDRA version: 7 Level: low Classification code 10012613
Conditions
Interventions
Product Code: RO0730699/F03
Pharmaceutical Form: Film-coated tablet
Other descriptive name: DPP IV (1)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmace
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Type 2 diabetes treated with the maximum tolerated dose of metformin (minimum 1500 mg daily dose, maximum not higher than recommended in the label) for at least 3 months before screening - HbA1c > or equal 7.0% and 126 mg/dL (7.0 mmol/L) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Type 1 diabetes - History of ketoacidosis or lactic acidosis - Any anti-hyperglycemic medication other than metformin during the last 3 months (combination therapy) - Use of systemic corticosteroids during the last 3 months - History of convulsions and/or epilepsy - Central nervous system disease with potential impact on the blood brain barrier, ie. history of stroke, Alzheimer’s disease, cerebrovascular dementia. - Impaired liver function (ALAT, ASAT, total bilirubin or alkaline phosphatase >2.5 x ULN) at screening - Contraindications to metformin, i.e. * Impaired renal function (serum creatinine > 1.5 mg/dL [ > 133 micromol/L] in males and >1.3 mg/dL [>115micromol/L] in females) * Congestive heart failure requiring pharmacologic treatment * Respiratory insufficiency - Myocardial infarction 160 mmHg and/or DBP > 100 mmHg despite treatment) - Known proliferative diabetic retinopathy - Serious illness, such as active cancer, major active infection, severe psychiatric disorders - Pregnant or lactating women or women with childbearing potential not using adequate method of contraception - Participation in a clinical trial with an investigational drug within 3 months prior to the screening examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the doses of RO0730699 which, when added to metformin, are efficacious, safe and tolerable compared to metformin alone in patients with type 2 diabetes ;Secondary Objective: To investigate by a population analysis approach the pharmacokinetics and the exposure-response relationship of RO0730699 in the target population;Primary end point(s): Absolute change in HbA1c from baseline to the end of treatment | — |
Countries
Germany, Italy
Outcome results
None listed