Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
 

Tracking Information

Start Date  ICMJESeptember 2008
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)		To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00765830 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 2, 2008)		To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
Official Title  ICMJEA 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Renal Insufficiency
Intervention  ICMJE
  • Drug: vildagliptin
    50mg qd
  • Drug: Placebo
    qd
Study Arms / Comparison Groups
  • 1: Experimental
    50mg qd vildagliptin
    Intervention: Drug: vildagliptin
  • 2: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE292
Estimated Completion DateApril 2010
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Complete the core study

Exclusion Criteria:

  • Did not comply with core study requirements
GenderBoth
Ages18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: External Affairs862-778-8300 (US)
Location Countries  ICMJEArgentina,   Australia,   Canada,   Costa Rica,   Finland,   France,   Germany,   India,   Norway,   Russian Federation,   Spain,   Sweden

Administrative Information

NCT ID  ICMJENCT00765830
Responsible PartyExternal Affairs, Novartis
Study ID Numbers  ICMJECLAF237A23137E1
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByNovartis