NCT02592421

SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2

Protocol 2: Elucidation of Mechanisms Responsible for the Increase in EGP Following SGLT2 Inhibition: Decrease in Plasma Glucose Conc or Change in Islet Hormone (Glucagon/Insulin) Secretion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The inhibition of the renal (kidney) SGLT2 transporter has proven to be an effective therapeutic intervention to reduce plasma glucose levels (amount of glucose found in the liquid part of blood) and HbA1c. In this study, the investigators hope to define the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration. The investigators will examine whether the signal for the increase in EGP (endogenous glucose production) caused by glucosuria (an excess of sugar in the urine, typically associated with diabetes) is mediated via the decrease in plasma glucose and insulin concentrations, or by the increase in plasma glucagon concentration.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Dapagliflozin	SGLT2 inhibitor (dapagliflozin)
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2015-10-23
• Primary completion: 2018-10-01
• Completion: 2019-10-31
• First posted: 2015-10-30
• Last updated: 2020-09-17
• Results posted: 2019-12-18

Locations

1 site across 1 country: United States