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Experimental Study to Validate the Modified Glucose Disposal Test

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01152372
Enrollment
36
Registered
2010-06-29
Start date
2010-06-30
Completion date
2010-11-30
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

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

Interventions

PROCEDUREInsulin, glucose and staple isotopes

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretionwithin 24 hours

Secondary

MeasureTime frame
Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellituswithin 24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026