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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004268-21-DE

Enrollment

370

Registered

2005-12-21

Start date

2006-02-17

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Mellitus MedDRA version: 7 Level: low Classification code 10012613

Interventions

Product Code: RO4389620/F07 Pharmaceutical Form: Capsule, soft Current Sponsor code: RO4389620 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Code: RO

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Significant coronary events, e.g., unstable angina, myocardial infarction within the past 3 months 2. Congestive heart failure requiring pharmacologic therapy in patients taking metformin 3. Transient ischemic attacks, or cerebrovascular accident within the past 3 months 4. Significant chronic illness, e.g., respiratory insufficiency, active malignant diseases, major active infection, or unstable mental disorders 5. Uncontrolled hypertension: All countries except Canada: Uncontrolled hypertension (SBP >160 mmHg and/or DBP >100 mmHg, with or without treatment) Canada only: Uncontrolled hypertension (SBP >150 mmHg and/or DBP >90 mmHg, with or without treatment) 6. 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) 7. 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 8. Serum creatinine > 2.0 mg/dl [177 µmol/L] (Patients taking metformin with a creatinine = 1.5 mg/dl [132.6 µmol/L] in man and = 1.4 mg/dl [ 123.76 µmol/L] in woman) at the ET or PW assessment in BM18248 or BM18249 9. Any abnormality in clinical laboratory tests or ECG, which precludes their safe involvement in the study as judged by the investigator 10. Pregnant or lactating women 11. 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 12. Alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the long-term safety and tolerability profile of RO4389620 at a dose, ranging from 25 mg BID to 100 mg BID, administered alone or in combination with metformin during 52-week treatment in patients with type 2 diabetes by monitoring adverse events, hypoglycemic events, physical examination, and selected laboratory variables.;Secondary Objective: - The effect of RO4389620 on long-term glycemic control when administered as either a monotherapy regimen or in combination with metformin will be analyzed descriptively at the end of the study. ;Primary end point(s): SAFETY Safety and tolerability will be assessed on the scope of all data collected from adverse events, hypoglycemic episodes, physical examination, and clinical laboratory during the treatment phase in the safety population: • Incidences of serious adverse events (SAE) • Proportion of patients with adverse events (AE) and the relationship to study drug • Proportion of patients with hypoglycemia, incidence of hypoglycemia and episodes • Physical examination, vital signs • Body weight, BMI, waist to hip ratio • Clinical laboratory variables in hematology, chemistry (ALT, AST, and creatinine), lipid profile, and urinalysis parameters. • 12 leads ECG over the treatment period EFFICACY Effect of long-team diabetic control will be assessed descriptively: • Mean changes from original baseline in HbA1c and FPG. • Categorical assessment of HbA1c response rate • Mean changes from original baseline in lipid profile	—

Measure

Time frame

Main Objective: - To evaluate the long-term safety and tolerability profile of RO4389620 at a dose, ranging from 25 mg BID to 100 mg BID, administered alone or in combination with metformin during 52-week treatment in patients with type 2 diabetes by monitoring adverse events, hypoglycemic events, physical examination, and selected laboratory variables.;Secondary Objective: - The effect of RO4389620 on long-term glycemic control when administered as either a monotherapy regimen or in combination with metformin will be analyzed descriptively at the end of the study. ;Primary end point(s): SAFETY Safety and tolerability will be assessed on the scope of all data collected from adverse events, hypoglycemic episodes, physical examination, and clinical laboratory during the treatment phase in the safety population: • Incidences of serious adverse events (SAE) • Proportion of patients with adverse events (AE) and the relationship to study drug • Proportion of patients with hypoglycemia, incidence of hypoglycemia and episodes • Physical examination, vital signs • Body weight, BMI, waist to hip ratio • Clinical laboratory variables in hematology, chemistry (ALT, AST, and creatinine), lipid profile, and urinalysis parameters. • 12 leads ECG over the treatment period EFFICACY Effect of long-team diabetic control will be assessed descriptively: • Mean changes from original baseline in HbA1c and FPG. • Categorical assessment of HbA1c response rate • Mean changes from original baseline in lipid profile

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Countries

Germany, Hungary, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026