Experimental Study to Validate the Modified Glucose Disposal Test

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Procedure: Insulin, glucose and staple isotopes

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152372

MB122-003

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Arm 1

Other group

Description:

Beta cell function by frequently sampled intravenous glucose tolerance test

Treatment:

Procedure: Insulin, glucose and staple isotopes

Arm 2

Other group

Description:

Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion

Treatment:

Procedure: Insulin, glucose and staple isotopes

Arm 3

Other group

Description:

Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp

Treatment:

Procedure: Insulin, glucose and staple isotopes