Experimental Study to Validate the Modified Glucose Disposal Test

Phase 1

Completed

• Conditions: Diabetes

• Registration Number: NCT01152372
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2010-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion	within 24 hours

Secondary Outcome Measures

Name	Time	Method
Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus	within 24 hours

Trial Locations

Locations (1)

Profil Institute For Clinical Research, Inc. (Picr); 🇺🇸 Chula Vista, California, United States