Phase 4 N=107 Randomized Basic Science

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT03331289 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Change in EGP From Baseline to Post-oral Glucose Load. — -0.03; -0.18; 0.14; -0.08 mg/kg.min

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug); Exenatide (Drug); Dapagliflozin (Drug); Exenatide and Dapagliflozin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center at San Antonio
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in EGP From Baseline to Post-oral Glucose Load.	-0.03; -0.18; 0.14; -0.08	—

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 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

Eligibility Criteria

Inclusion Criteria

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 Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03331289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.