A multi-center, double-blind, randomized, placebo-controlled dose-ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of RO4389620 in patients with type 2 diabetes mellitus treated with a stable dose of metformi

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 7Level: lowClassification code 10012613

• Registration Number: EUCTR2005-002908-42-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-30
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Age 30 to 75 years at the time of the screening examination
• Type 2 diabetes mellitus patients treated with individual maximal tolerated daily dose of metformin monotherapy (minimal metformin daily dose more or equal than 1.5 g, maximum not higher than recommended in the label) for at least 3 months prior to screening
• HbA1c more or equal than 7.0 % and = 10.0 % at screening
• FPG > 126 mg/dL (7.0 mmol/L) and = 240 mg/dL (13.3 mmol/L) at screening
• 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

Exclusion Criteria

Patients meeting ANY of the following criteria are NOT eligible for this study.
1.Type 1 diabetes mellitus patients
2.Any severe hypoglycemic episodes within the last 3 months (requiring assistance by another person to recover)
3.Frequent (more than 3-4 episodes per week) moderate hypoglycemic episodes
4.History of ketoacidosis or lactic acidosis
5.Treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during the last 3 months
6.Treatment with insulin, except insulin use in emergency situations or during surgery for up to 7 days, but not within 3 months prior to the screening visit
7.Treatment 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)
8.Systemic use of corticosteroids in the last 3 months
9.Contraindications to metformin, i.e.
–Congestive heart failure requiring pharmacologic treatment
–Respiratory insufficiency
10.Impaired liver function (ALAT, ASAT, total and direct bilirubin or alkaline phosphatase > 2.5x ULN) at screening
11.Severe and moderate renal impairment (creatinine clearance < 50 mL/min/1.73m2) at screening
12.Uncontrolled hypertension
All countries except Canada:
Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of the screening examination
Canada only:
Uncontrolled hypertension (SBP > 150 mmHg and/or DBP > 90 mmHg, despite treatment) at the time of the screening examination
13.Myocardial infarction or stroke within 6 months prior to the screening examination
14.Known proliferative diabetic retinopathy
15.Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator.
16.Pregnant or lactating women
17.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 last study drug intake
18.Participation in an investigational drug study within 90 days (3 months) prior to screening
19.Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination
20.Alcohol or drug abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified