Phase 4
Completed N=107
Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria
Source: ClinicalTrials.gov NCT03331289 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Change in EGP From Baseline to Post-oral Glucose Load. — -0.03; -0.18; 0.14; -0.08 mg/kg.min
◆ Published Evidence
Emerging
10citations · ~3 / year
Dapagliflozin Impairs the Suppression of Endogenous Glucose Production in Type 2 Diabetes Following Oral Glucose.
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
Linked Publications
-
Dapagliflozin Impairs the Suppression of Endogenous Glucose Production in Type 2 Diabetes Following Oral Glucose.
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 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03331289) and the linked publication. 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. Informational only — not medical advice.