Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Product Name: DPP-IV Inhibitor
Product Code: RO4876904
Pharmaceutical Form: Capsule*
Concentration unit: mg milligram(s)
Concentration t
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 drug naïve or pre-treated with 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 7.0 – 10.0 % at screening ?BMI 25-45 kg/m2 at screening ?Age 18 to 75 years at screening ?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: ?Type 1 diabetes ?FPG > 13.3 mmol/L (> 240 mg/dL) at screening ?Any anti-hyperglycemic medication other than metformin or weight lowering drug during the last 3 months ?History of diabetic ketoacidosis ?Impaired renal function •For naïve patients: serum creatinine > 2.0 mg/dL [>177 µmol/L] •For metformin treated patients: > 1.5 mg/dL [> 133 µmol/L] in males and > 1.4 mg/dl [> 124 µmol/L] in females ?For patients on metformin only: any other contraindication to metformin as indicated in the label such as congestive heart failure requiring pharmacological treatment and respiratory failure ?Use of systemic corticosteroids during the 3 months before screening ?Triglycerides > 600 mg/dL at screening ?Impaired liver function (ALT, AST, total bilirubin or alkaline phosphatase > 2.5 x ULN) at screening ?Myocardial infarction 160 mmHg and/or DBP > 100 mmHg despite treatment) at screening ?Known proliferative diabetic retinopathy ?Bariatric surgery for obesity (e.g. Roux-en-Y, banding etc) ?Any abnormalities in clinical laboratory tests or ECG which preclude safe involvement in the study as judged by the investigator ?Serious illness, e.g. active cancer, major active infection or severe psychiatric disorders at the time of the screening examination or any condition that may interfere with the study conduct, based on the judgment of the investigator ?Pregnant or lactating women and women with childbearing potential not using adequate method of contraception ?Previous exposure to GLP-1, GLP-1 analogues or exenatide ?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: Absolute change in HbA1c from baseline to end of study;Secondary Objective: To determine additional efficacy parameters, safety and tolerability following RO4876904 compared to palcebo. To investigate by a population analysis approach the pharmacokinetics and the exposure-response relationship of RO4876904 in the target population includingthe influence covariates.;Primary end point(s): ?Absolute change in HbA1c from baseline to the end of treatment | — |
Countries
Spain, United Kingdom
Outcome results
None listed