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OpenTrials
Completed

NCT Number: NCT00380380

A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.

Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.

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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

Primary location

Munich, 81377, Germany

Munich, Germany

Who can participate

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

Inclusion criteria

  • Must be able to complete a 1-week wash-out of current anti-diabetic medications
  • Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
  • Blood glucose criteria must be met
  • BMI <40

Exclusion criteria

  • History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Need for insulin within 3 months or patients on thiazolidinediones
  • Significant concommitant disease or complications of diabetes
  • Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
  • Abnormal liver function tests as defined by the protocol
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Evaluate the effects of acute effects of vildagliptin on gastric emptying

Secondary outcomes

  1. Effect on steady state levels of active GLP-1 and GIP

  2. Change in fasting and postprandial glucose levels.

  3. Change in glucagon secretion

  4. Change in postprandial glucose kinetics

  5. Effect on gastric peristalsis

  6. Effect on satiety

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Single-blind, Placebo Controlled, Cross-over Study to Evaluate the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Sep 26, 2006
Registry last updated
Feb 23, 2017

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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