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Clinical Trials/EUCTR2005-004268-21-DE
EUCTR2005-004268-21-DEActive, not recruitingNot Applicable

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.

F. Hoffmann-La Roche Ltd0 sites370 target enrollmentStarted: December 21, 2005Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
370
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

  • •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
  • •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
  • •12. Alcohol or drug abuse

Investigators

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