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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

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ClinicalTrials.gov Identifier: NCT00260156
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2005
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vildagliptin Drug: vildagliptin
Placebo Comparator: Placebo Drug: placebo



Primary Outcome Measures :
  1. Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in disposition index at 52 weeks [ Time Frame: 52 weeks ]
  2. Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ]
  3. Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ]
  4. Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks [ Time Frame: 52 weeks ]
  5. Beta-cell function parameter derived from standard meal challenge [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260156


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00260156     History of Changes
Other Study ID Numbers: CLAF237A2381
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Hypoglycemic Agents
Physiological Effects of Drugs