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Completed

NCT Number: NCT00351546

A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 2 diabetes at least 3 months prior to screening
  • Blood glucose criteria must be met
  • On stable dose of metformin therapy
  • BMI less than or equal to 39

Exclusion criteria

  • Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
  • Treatment with thiazolidinediones or use of insulin within the previous 3 months
  • Significant illness within 2 weeks prior to dosing
  • High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Effect on insulin sensitivity at 6 weeks

Secondary outcomes

  1. Lipolysis rate after 6 weeks of treatment

  2. Plasma free fatty acid concentration after 6 weeks of treatment

  3. Hepatic glucose production after 6 weeks of treatment

  4. Glucose disposal after 6 weeks of treatment

  5. Gluconeogenesis rate after 6 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jul 13, 2006
Registry last updated
May 7, 2012

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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