Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPPIV inhibitor RO0730699 in patients with type 2 diabetes - NA
- Conditions
- Type 2 diabetesMedDRA version: 7Level: lowClassification code 10012613
- Registration Number
- EUCTR2004-004528-11-EE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
- 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 10.0% at screening
> or equal 7.0% and < or equal 10.0% at pre-randomization visit
- FPG at pre-randomization visit
> 7.0 mmol/L (126 mg/dL) and
< or equal 13.3 mmol/L (240 mg/dL)
- BMI < or equal 40 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
- 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 < 6 months before screening
- Uncontrolled hypertension (SBP > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method