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Completed

NCT Number: NCT00351507

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

This study was designed to directly assess the effects of vildagliptin on gastric emptying 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 Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

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
  • Blood glucose criteria must be met
  • BMI in the range 22-40

Exclusion criteria

  • History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Use of thiazolidinediones or need for insulin within 3 months prior to screening
  • Significant concomitant diseases or complications of diabetes
  • 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 gastric emptying

Secondary outcomes

  1. Effect on gastric volume

  2. Effect on satiety

  3. Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
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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