Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312130
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.

Condition or disease Intervention/treatment Phase
Pre-diabetes Drug: Vildagliptin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Single-blind, Single-treatment Study to Evaluate the Effects of Vildagliptin on Response to an Intravenous Glucose Load in Pre-diabetic Subjects With Impaired Fasting Glucose
Study Start Date : April 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes




Primary Outcome Measures :
  1. Change from baseline in acute insulin response to an iv glucose load at 6 weeks

Secondary Outcome Measures :
  1. Change from baseline in glucose disappearance rate at 6 weeks
  2. Change from baseline in glucose disappearance rate at 8 weeks
  3. Change from baseline in insulin sensitivity at 6 weeks
  4. Change from baseline in insulin sensitivity at 8 weeks
  5. Change from baseline in acute insulin response to an iv glucose load at 8 weeks


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI in the range 22-45 and with a stable weight for the last 6 months
  • Blood glucose criteria must be met
  • Written informed consent

Exclusion Criteria:

  • Pregnancy or lactation
  • Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents
  • Type 1 diabetes
  • Evidence of cardiovascular complications as defined by the protocol
  • Evidence of diabetic complications as defined by the protocol

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): NCT00312130


Locations
Layout table for location information
United States, Washington
University of Washington
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Novartis
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00312130     History of Changes
Other Study ID Numbers: CLAF237A2345
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Vildaglptin
Pre-diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action