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NCT Number: NCT02592421

SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2

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.

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

SGLT2 inhibitor (dapagliflozin)

Other names: Farxiga

Placebo

Drug

Placebo Comparator

Primary outcomes

  1. Change in Plasma Glucose Concentration

    Time frame: Baseline to 240-300 minutes

    Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration

  2. Change in Endogenous Glucose Production (EGP)

    Time frame: Baseline to 240-300 minutes

    The change in endogenous glucose production is measured from baseline until the last hour of the study

Secondary outcomes

  1. Change in Plasma Insulin During Measurement of EGP

    Time frame: Baseline to 240-300 minutes

    Measurement of change in plasma insulin concentration during measurement of of EGP from baseline to last hour of the study

  2. Change in Glucagon During EGP Measurement

    Time frame: Baseline to 240-300 minutes

    Measurement of change in glucagon during EGP measurement from baseline to the last hour of the study

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 30, 2015
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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