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A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00351507
First received: July 11, 2006
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effect on gastric emptying

Secondary Outcome Measures:
  • Effect on gastric volume
  • Effect on satiety
  • Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Enrollment: 10
Study Start Date: May 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least 6 months
  • Blood glucose criteria must be met
  • BMI in the range 22-40

Exclusion Criteria:

  • History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Use of thiazolidinediones or need for insulin within 3 months prior to screening
  • Significant concomitant diseases or complications of diabetes
  • High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351507

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Adrian Vella, MD Mayo Clinic & Foundation
  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: NCT00351507     History of Changes
Other Study ID Numbers: CLAF237A2343
Study First Received: July 11, 2006
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Vildagliptin
Type 2 diabetes

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 May 19, 2013