Paradoxical Stimulation of Hepatic Glucose Production With Dapagliflozin

• Status: Completed
• Trial end date: 2019-11-16
• Target enrollment: 0
• Participant gender: All

Summary

To determine the role of plasma glucagon and insulin in the rise of endogenous glucose production (EGP) following the SGLT2 inhibition.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• T2DM according to ADA criteria-HbA1C < 8.0%

• BMI = 25-35 kg/m2

• Subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis

• Body weight has been stable (± 3 lbs) over the preceding three months

• Do not participate in an excessively heavy exercise program

• Taking stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea

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