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OpenTrials
Completed

NCT Number: NCT00260156

A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Not currently on drug therapy for type 2 diabetes
  • Blood glucose criteria must be met

Exclusion criteria

  • History of type 1 diabetes
  • Evidence of significant diabetic complications
  • Serious cardiovascular events within the past 6 months
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks

    Time frame: 52 weeks

Secondary outcomes

  1. Change from baseline in disposition index at 52 weeks

    Time frame: 52 weeks

  2. Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks

    Time frame: 52 weeks

  3. Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks

    Time frame: 52 weeks

  4. Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks

    Time frame: 52 weeks

  5. Beta-cell function parameter derived from standard meal challenge

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 1, 2005
Registry last updated
Dec 17, 2020

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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