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Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00770081
First received: October 8, 2008
Last updated: January 2, 2013
Last verified: May 2012
History of Changes
  Purpose

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Renal Insufficiency
 Drug: vildagliptin
Drug: sitagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
50mg qd vildagliptin
 Drug: vildagliptin
50mg qd
Active Comparator: 2
sitagliptin (25mg qd)
 Drug: sitagliptin
25mg qd

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete the core study and consent for extension

Exclusion Criteria:

  • Patient unable to comply with core study requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770081

  Show 87 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00770081     History of Changes
Other Study ID Numbers: CLAF237A23138E1
Study First Received: October 8, 2008
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Vildagliptin
 Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013