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Completed

NCT Number: NCT00312130

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

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.

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Washington

Seattle, Washington, 98108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 7, 2006
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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