Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPP-IV inhibitor RO4876904 in patients with type 2 diabetes
- Conditions
- Type 2 diabetesMedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
- Registration Number
- EUCTR2007-001257-25-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
?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
?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 < 6 months before screening
?Uncontrolled hypertension (SBP > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method