A multicenter, open label, extension study to evaluate the long-term safety and tolerability of RO4389620 in type 2 diabetic patients from studies BM18248 or BM18249.

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

• Registration Number: EUCTR2005-004268-21-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Type 2 diabetic patients who have completed phase 2 studies BM18248 or BM18249; OR who have discontinued participation due to hypoglycemia as per protocols

• Patients able and willing to give written informed consent and to comply with the requirements of the present protocol

• Patients considered by the investigator as suitable for long term treatment with RO4389620 with regards to compliance and risk assessment

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

- Significant coronary events, e.g., unstable angina, myocardial infarction within the past 3 months
- Congestive heart failure requiring pharmacologic therapy in patients taking metformin
- Transient ischemic attacks, or cerebrovascular accident within the past 3 months
- Significant chronic illness, e.g., respiratory insufficiency, active malignant diseases, major active infection, or unstable mental disorders
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, with or without treatment)
- Concomitant use of systemic treatment with strong CYP450 3A4 inducers (such as rifampicin), or potent CYP450 3A4 inhibitors (such as atanazavir, indinavir, nelfinavir, ritonavir, saquinavir, itraconazole, ketoconazole, voriconazole nefazodone, telithromycin or clarithromycin)
- Impaired liver function (ALT, AST, total and direct bilirubin or Alk. phosphatase > 2.5 x ULN) at the end-of-treatment (ET) or premature withdrawal (PW) assessment in BM18248 or BM18249
- Serum creatinine > 2.0 mg/dl [177 µmol/L] (Patients taking metformin with a creatinine equal or more than 1.5 mg/dl in man and equal or morel than 1.4 mg/dl in woman) at the ET or PW assessment in BM18248 or BM18249
- Any abnormality in clinical laboratory tests or ECG, which precludes their safe involvement in the study as judged by the investigator
- Pregnant or lactating women
- Women of child bearing potential who, with their partners refuse to use two forms of contraception (including one barrier method) during the treatment and follow-up periods
- Alcohol or drug abuse

Study & Design

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