Status:
COMPLETED
Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 measur...
Detailed Description
Eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03331289
Start Date
February 28 2018
End Date
November 4 2022
Last Update
July 24 2023
Active Locations (1)
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1
University Health System Texas Diabetic Institute
San Antonio, Texas, United States, 78207