A multi-center phase 2 randomized, double-blind, placebo-controlled dose-ranging study to determine the efficacy, safety, tolerability and pharmacokinetics of RO4389620 in patients with type 2 diabetes mellitus
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 7Level: lowClassification code 10012613
- Registration Number
- EUCTR2005-002907-18-HU
- 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
- Age 30 to 75 years at the time of the screening examination
- A medical history of type 2 diabetes mellitus as defined by World Health Organization for longer than 3 months prior to screening
- Male and female patients either treatment naïve inadequately controlled despite diet and exercise or inadequately controlled patients on monotherapy or on combination therapy (max. 2 oral antihyperglycemic medications)
- HbA1c = 10.0 % at screening and HbA1c more or equal than 7.0 % and = 10.0 % at pre-randomization visit
- FPG > 126 mg/dL (7.0 mmol/L) and = 240 mg/dL (13.3 mmol/L) at pre-randomization visit
- BMI = 45 kg/m2 at screening
- Patients 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 mellitus patients
- Any severe hypoglycemic episode within the last 3 months (requiring assistance by another person to recover)
- Frequent (more than 3-4 episodes per week) moderate hypoglycemic episodes
- History of ketoacidosis
- Type 2 diabetes mellitus patients treated with insulin or PPAR? (e.g. Actos®, Avandia®, Avandamet®) during the last 3 months
- Any antidiabetic drug not stopped at start of wash-out/placebo run-in period
- Treatement with strong CYP450 3A4 inducers (such as rifampicin), or potent CYP450 3A4 inhibitors (such as atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole)
- Systemic use of corticosteroids in the last 3 months
- Impaired liver function (ALAT, ASAT, total and direct bilirubin or alkaline phosphatase > 2.5x ULN) at screening or pre-randomization examination
- Severely impaired kidney function (creatinine clearance < 30 mL/min/1.73 m2) at screening or pre-randomization examination
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of the screening examination
- Myocardial infarction or stroke within 6 months prior to the screening examination
- Known proliferative diabetic retinopathy
- Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the investigator.
- Body weight change between screening and pre-randomization more or equal than +/- 10 %
- Pregnant or lactating women
- Female patients of childbearing potential who with their partners refuse to use two forms of contraception (including 1 barrier method) from screening and for one month following the last study drug intake
- Participation in an investigational drug study within 90 days (3 months) prior to screening
- Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination
- Alcohol or drug abuse
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 BID dose(s) of RO4389620, which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes;Secondary Objective: - To investigate the effects of RO4389620 on additional parameters of glycemic and lipid control<br><br>- To investigate, by a population analysis approach, the pharmacokinetics and the exposure-response relationship of RO4389620 in the target population, including the influence of covariates<br><br>- To explore the efficacy and safety of 100 mg QD regimen of RO4389620 <br>;Primary end point(s): HbA1c mean change from baseline at the end of the treatment period compared to placebo
- Secondary Outcome Measures
Name Time Method