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Experimental Study to Validate the Modified Glucose Disposal Test

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152372
First Posted: June 29, 2010
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152372


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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01152372     History of Changes
Other Study ID Numbers: MB122-003
First Submitted: June 16, 2010
First Posted: June 29, 2010
Last Update Posted: February 23, 2011
Last Verified: August 2010

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs