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OpenTrials
Completed

NCT Number: NCT00396071

Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin

This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.

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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–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Diabetes Zentrum Bad Lauterberg, Bad Lauterberg im Harz, Germany

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Who can participate

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

Inclusion criteria

  • Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
  • Agreement to maintain the same dose of metformin throughout the study
  • Body mass index (BMI) in the range of 22-35 kg/m2
  • HbA1c in the range of 7.0 to 9.0%
  • FPG <200 mg/dl (11.1 mmol/L)
  • Agreement to maintain prior diet and exercise habits during the full course of the study
  • Ability to comply with all study requirements and signed informed consent to participate in the study

Exclusion criteria

  • A history of type 1 diabetes
  • A history of acute metabolic diabetic complications
  • Evidence of significant diabetic complications
  • Insulin treatment for longer than 10 days within the past 6 months
  • Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

vildagliptin 100 mg

Other names: Galvus

Placebo

Drug

matching placebo

Primary outcomes

  1. Change in C-peptide IAUC (0-4hr)

    Time frame: 2 weeks after treatment

Secondary outcomes

  1. Change in insulin secretion rate (ISR) relative to glucose (0-2hr)

    Time frame: after 2 weeks of treatment

  2. Change in postprandial C-peptide

    Time frame: after two weeks of treatment

  3. Change in postprandial insulin

    Time frame: after two weeks of treatment

  4. Change in postprandial glucagon

    Time frame: after two weeks of treatment

  5. Change in postprandial GLP-1

    Time frame: after 2 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin

Important dates

Study start
2006
Primary completion
2007
First posted
Nov 6, 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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