Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency


Tracking Information

Start Date  ICMJEMarch 2005
Estimated Primary Completion DateSeptember 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 HistoryComplete list of historical versions of study NCT00646542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 22, 2009)
  • To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: March 26, 2008)
  • To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.
  • To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.

Descriptive Information

Brief Title  ICMJESafety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Official Title  ICMJEThis 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Vildagliptin
    Other Name: Galvus
  • Drug: Placebo
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: Vildagliptin
  • 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE300
Completion Date 
Estimated Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History T2DM
  • Moderate or Severe Renal Impairment

Exclusion Criteria:

  • Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

GenderBoth
Ages18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Customer Information Center(862) 778-8300
Location Countries  ICMJEArgentina,   Australia,   Canada,   Costa Rica,   Finland,   France,   Germany,   India,   Norway,   Russian Federation,   Spain,   Sweden

Administrative Information

NCT ID  ICMJENCT00646542
Responsible PartyExternal Affairs, Novartis Pharmaceuticals Corporation
Study ID Numbers  ICMJECLAF237A23137
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByNovartis