Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

Research Design/Plan: After screening, each subject will receive 1 measurements of Endogenous Glucose Production \[EGP\] with prime-continuous Infusion of 3-3H-glucose. After completing the EGP measurement each subject will receive a Double Tracer Oral Glucose Tolerance Test \[OGTT\]. Methods: Visit 1: Screening. Medical history will be obtained, physical exam performed, and pregnancy test performed. Visit 2: Endogenous Glucose Production Measurement: The rate of EGP will be measured with 3-3H-glucose. Visit 3: Double Tracer OGTT

Key facts

Study ID: NCT03331289
Run by: The University of Texas Health Science Center at San Antonio
People needed: 107
Starts: 2018-02-28
Expected to finish: 2022-11-04
Last updated by the study team: 2023-07-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in good general health as determined by physical exam, medical history, blood chemistry-CBC, TSH, T4, EKG and urinalysis)
BMI: 21-45kg/m
HbA1C>7.0% and <10.5%
Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more than 3 months)

You may not qualify if…

Health Status: Type 1 Diabetics
Proliferative diabetic retinopathy
Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males, or 24 hour urine albumin excretion greater than 300mg/dL
Medication: Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)

Where it is running

University Health System Texas Diabetic Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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