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Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 25-35 kg/m^2
  • Normal Glucose Tolerance subjects (24)
  • Type 2 Diabetic Subjects (24)
  • Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
  • Diabetic subjects must have HbA1c <8.0%
  • Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
  • Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

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.

Sites / Locations

  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

T2DM individuals on Dapagliflozin

T2DM individuals on Placebo

Normal Glucose Tolerance (NGT) on Dapagliflozin

Normal Glucose Tolerance (NGT) Placebo

Arm Description

Individuals with type 2 diabetes mellitus - dapagliflozin

Individuals with type 2 diabetes mellitus on placebo

Individuals with normal glucose tolerance - dapagliflozin

Individuals with normal glucose tolerance - on placebo

Outcomes

Primary Outcome Measures

Endogenous Glucose Production Measurement
Endogenous Glucose Production NGT subjects after dapagliflozin administration. Measured as free plasma glucose

Secondary Outcome Measures

Renal Glucose Production Measurement of Change
Renal Glucose Production in T2DM and NGT subjects after dapagliflozin/placebo administration

Full Information

First Posted
November 30, 2016
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02981966
Brief Title
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
Official Title
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
Detailed Description
Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T2DM individuals on Dapagliflozin
Arm Type
Active Comparator
Arm Description
Individuals with type 2 diabetes mellitus - dapagliflozin
Arm Title
T2DM individuals on Placebo
Arm Type
Placebo Comparator
Arm Description
Individuals with type 2 diabetes mellitus on placebo
Arm Title
Normal Glucose Tolerance (NGT) on Dapagliflozin
Arm Type
Active Comparator
Arm Description
Individuals with normal glucose tolerance - dapagliflozin
Arm Title
Normal Glucose Tolerance (NGT) Placebo
Arm Type
Placebo Comparator
Arm Description
Individuals with normal glucose tolerance - on placebo
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
Farxiga
Intervention Description
dapagliflozin, 10mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for dapagliflozin
Primary Outcome Measure Information:
Title
Endogenous Glucose Production Measurement
Description
Endogenous Glucose Production NGT subjects after dapagliflozin administration. Measured as free plasma glucose
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Renal Glucose Production Measurement of Change
Description
Renal Glucose Production in T2DM and NGT subjects after dapagliflozin/placebo administration
Time Frame
Baseline to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 25-35 kg/m^2 Normal Glucose Tolerance subjects (24) Type 2 Diabetic Subjects (24) Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea Diabetic subjects must have HbA1c <8.0% Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis. Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenio Cersosimo, MD,PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

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