SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2

• Status: Completed
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP following SGLT2 inhibition.

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

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• T2DM subjects

• 18 - 70 yrs old

• BMI = 25-45 kg/m2

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

• HbA1c <10.0%

• Stable body weight (± 3 lbs) over preceding 3 months

• Do not participate in excessively heavy exercise

Exclusion Criteria:

• Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)

• Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg