Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Tracking Information
Start Date ICMJE | March 2005 |
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Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: July 22, 2009) | To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: March 26, 2008) | To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment |
Change History | Complete list of historical versions of study NCT00646542 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 22, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: March 26, 2008) |
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Descriptive Information
Brief Title ICMJE | Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency |
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Official Title ICMJE | This Study is Not Being Conducted in the United States. A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency |
Brief Summary | This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Condition ICMJE | Diabetes Mellitus, Type 2 |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 300 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. | ||||
Gender | Both | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Argentina, Australia, Canada, Costa Rica, Finland, France, Germany, India, Norway, Russian Federation, Spain, Sweden |
Administrative Information
NCT ID ICMJE | NCT00646542 |
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Responsible Party | External Affairs, Novartis Pharmaceuticals Corporation |
Study ID Numbers ICMJE | CLAF237A23137 |
Study Sponsor ICMJE | Novartis |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Novartis |
Source: http://clinicaltrials.gov/