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A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: July 11, 2006
Last updated: May 4, 2012
Last verified: May 2012
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in maximal insulin secretory capacity at 12 weeks
  • Durability of this effect after a 2-week washout

Secondary Outcome Measures:
  • Change from baseline in beta-cell sensitivity to glucose at 12 weeks
  • Durability of this effect after a 2-week washout
  • Chance from baseline in glucagon secretion at 12 weeks

Enrollment: 39
Study Start Date: July 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least 6 months
  • Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
  • BMI in the range 22-45
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes or diabetes resulting from pancreatic injury
  • Cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its identifier: NCT00351585

Sponsors and Collaborators
Principal Investigator: David D'Alessio, MD University of Cincinnati
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00351585     History of Changes
Other Study ID Numbers: CLAF237A2344
Study First Received: July 11, 2006
Last Updated: May 4, 2012

Keywords provided by Novartis:
Type 2 diabetes
Insulin secretion
Beta cell

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017