Type 2 diabetes MedDRA version: 7 Level: low Classification code 10012613
Conditions
Interventions
Product Code: RO0730699
Pharmaceutical Form: Film-coated tablet
Other descriptive name: DPP IV (1)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 -
Pharmaceuti
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Type 2 diabetes diagnosed at least 1 month before screening and either drug naïve or pre-treated with monotherapy or combination therapy (max. two oral antihyperglycemic medications, not on maximum dose) - HbA1c or equal 7.0% and 7.0 mmol/L (126 mg/dL) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Type 1 diabetes - Type 2 diabetes treated with insulin or a PPAR? agonist (e.g. Actos ®, Avandia ®, Avandamet ®) during the 3 months before screening - History of ketoacidosis - Any antihyperglycemic medication not stopped at start of wash-out/placebo run-in period - Use of systemic corticosteroids during the 3 months before screening - History of convulsions and/or epilepsy - CNS disease with potential impact on the blood-brain barrier (e.g. history of stroke, Alzheimer`s disease, cerebrovascular dementia) - Impaired liver function (ALAT, ASAT, total bilirubin or alkaline phosphatase >2.5 x ULN) at screening - Impaired renal function (serum creatinine > or equal 177 micromol/L [> or equal2.0 mg/dL]) at screening - Myocardial infarction 160 mmHg and/or DBP > 100 mmHg despite treatment) at screening - Known proliferative diabetic retinopathy - Serious illness, e.g. active cancer, major active infection, or severe psychiatric disorders at the time of the screening examination - Positive pregnancy test, lactating women or women with childbearing potential unless using reliable 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 compared to placebo, are efficacious, safe and tolerable 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
Estonia, Latvia, Lithuania
Outcome results
None listed