Experimental Study to Validate the Modified Glucose Disposal Test

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152372
• Other study ID #: MB122-003
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2010
• Last updated: February 22, 2011
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• Insulin, glucose and staple isotopes

Locations

Country	Name	City	State
United States	Profil Institute For Clinical Research, Inc. (Picr)	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion		within 24 hours	No
Secondary	Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus		within 24 hours	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form