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Experimental Study to Validate the Modified Glucose Disposal Test

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: June 16, 2010
Last updated: February 22, 2011
Last verified: August 2010
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus

Condition Intervention Phase
Procedure: Insulin, glucose and staple isotopes
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus [ Time Frame: within 24 hours ]

Enrollment: 36
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Beta cell function by frequently sampled intravenous glucose tolerance test
Procedure: Insulin, glucose and staple isotopes
Arm 2
Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion
Procedure: Insulin, glucose and staple isotopes
Arm 3
Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp
Procedure: Insulin, glucose and staple isotopes


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01152372

United States, California
Profil Institute For Clinical Research, Inc. (Picr)
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT01152372     History of Changes
Other Study ID Numbers: MB122-003
Study First Received: June 16, 2010
Last Updated: February 22, 2011

Additional relevant MeSH terms:
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 26, 2017