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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00646542
First received: March 24, 2008
Last updated: January 3, 2013
Last verified: January 2013

March 24, 2008
January 3, 2013
March 2005
October 2010   (final data collection date for primary outcome measure)
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 ]
To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment
Complete list of historical versions of study NCT00646542 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Vildagliptin
    Other Name: Galvus
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: Vildagliptin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
525
Not Provided
October 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Costa Rica,   Finland,   France,   Germany,   India,   Norway,   Russian Federation,   Spain,   Sweden
 
NCT00646542
CLAF237A23137
Yes
Novartis
Novartis
Not Provided
Not Provided
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP