Skip to main content
OpenTrials
Completed

NCT Number: NCT01152372

Experimental Study to Validate the Modified Glucose Disposal Test

Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institute For Clinical Research, Inc. (Picr)

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Type 2 diabetes
  • Clinically healthy
  • Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue

Exclusion criteria

  • Type 1 Diabetes
  • History of significant heart disease.
  • Bariatric surgery
  • Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors

Treatment and study plan

Insulin, glucose and staple isotopes

Procedure

Primary outcomes

  1. Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion

    Time frame: within 24 hours

Secondary outcomes

  1. Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus

    Time frame: within 24 hours

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2010
Registry last updated
Feb 23, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.