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Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

NCT02981966

CompletedPhase 4

Sponsor: The University of Texas Health Science Center at San Antonio

Conditions: Diabetes Mellitus, Type 2

Interventions: Dapagliflozin, Placebo

Countries: United States

Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 25-35 kg/m\^2
* Normal Glucose Tolerance subjects (24)
* Type 2 Diabetic Subjects (24)
* Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
* Diabetic subjects must have HbA1c \<8.0%
* Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
* Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

Exclusion Criteria:

* Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males, or 24-hour urine albumin excretion \> 300 mg will be excluded.

Locations (1)

San Antonio, Texas, United States