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OpenTrials
Completed

NCT Number: NCT00351585

A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

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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–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 for at least 6 months
  • Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
  • BMI in the range 22-45
  • Blood glucose criteria must be met

Exclusion criteria

  • Pregnancy or lactation
  • Type 1 diabetes or diabetes resulting from pancreatic injury
  • Cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Change from baseline in maximal insulin secretory capacity at 12 weeks

  2. Durability of this effect after a 2-week washout

Secondary outcomes

  1. Change from baseline in beta-cell sensitivity to glucose at 12 weeks

  2. Durability of this effect after a 2-week washout

  3. Chance from baseline in glucagon secretion at 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2004
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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