Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02981966

Run by

The University of Texas Health Science Center at San Antonio

People needed

32

Starts

2019-05-23

Expected to finish

2023-05-31

Last updated by the study team

2024-03-04

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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