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A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00260156
First received: November 29, 2005
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: vildagliptin
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in disposition index at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Beta-cell function parameter derived from standard meal challenge [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: November 2005
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin Drug: vildagliptin
Placebo Comparator: Placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not currently on drug therapy for type 2 diabetes
  • Blood glucose criteria must be met

Exclusion Criteria:

  • History of type 1 diabetes
  • Evidence of significant diabetic complications
  • Serious cardiovascular events within the past 6 months
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260156

Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00260156     History of Changes
Other Study ID Numbers: CLAF237A2381
Study First Received: November 29, 2005
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
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 June 17, 2013