Experimental Study to Validate the Modified Glucose Disposal Test

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01152372
First received: June 16, 2010
Last updated: February 22, 2011
Last verified: August 2010
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01152372     History of Changes
Other Study ID Numbers: MB122-003
Study First Received: June 16, 2010
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014