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SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2

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ClinicalTrials.gov Identifier: NCT02592421
Recruitment Status : Completed
First Posted : October 30, 2015
Results First Posted : December 18, 2019
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: Dapagliflozin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 23, 2015
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dapagliflozin
20 subjects will receive dapagliflozin 10mg
Drug: Dapagliflozin
SGLT2 inhibitor (dapagliflozin)
Other Name: Farxiga

Placebo Comparator: Placebo
10 subjects will receive placebo
Drug: Placebo
Placebo Comparator




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592421


Locations
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United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ralph A. DeFronzo, MD The University of Texas Health Science Center at San Antonio
  Study Documents (Full-Text)

Documents provided by The University of Texas Health Science Center at San Antonio:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02592421    
Other Study ID Numbers: HSC20150668H
5R01DK107680-02 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2015    Key Record Dates
Results First Posted: December 18, 2019
Last Update Posted: September 17, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs