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Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02981966
Collaborator
AstraZeneca (Industry)
36
Enrollment
1
Location
2
Arms
54.3
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)
Actual Study Start Date :
May 23, 2019
Actual Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Normal Glucose Tolerance (NGT)

Individuals with normal glucose tolerance - dapagliflozin vs placebo

Drug: Dapagliflozin
dapagliflozin, 10mg tablet
Other Names:
  • Farxiga

    • Drug: Placebo
    Placebo for dapagliflozin
    Active Comparator: T2DM individuals

    Individuals with type 2 diabetes mellitus - dapagliflozin vs placebo

    Drug: Dapagliflozin
    dapagliflozin, 10mg tablet
    Other Names:
  • Farxiga

    • Drug: Placebo
    Placebo for dapagliflozin

    Outcome Measures

    Primary Outcome Measures

    1. Endogenous Glucose Production NGT subjects - dapa [3 weeks]

      Endogenous Glucose Production NGT subjects after dapagliflozin administration

    2. Endogenous Glucose Production NGT subjects - placebo [3 weeks]

      Endogenous Glucose Production NGT subjects after placebo administration

    3. Endogenous Glucose Production T2DM subjects - dapa [3 weeks]

      Endogenous Glucose Production T2DM subjects after dapagliflozin administration

    4. Endogenous Glucose Production T2DM subjects - placebo [3 weeks]

      Endogenous Glucose Production T2DM subjects after placebo administration

    Secondary Outcome Measures

    1. Renal Glucose Production NGT subjects - dapa [3 weeks]

      Renal Glucose Production NGT subjects after dapagliflozin administration

    2. Renal Glucose Production NGT subjects - placebo [3 weeks]

      Renal Glucose Production NGT subjects after placebo administration

    3. Renal Glucose Production T2DM subjects - dapa [3 weeks]

      Renal Glucose Production T2DM subjects after dapagliflozin administration

    4. Renal Glucose Production T2DM subjects - placebo [3 weeks]

      Renal Glucose Production T2DM subjects after placebo adminsitration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Health Science Center San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • AstraZeneca

    Investigators

    • Principal Investigator: Eugenio Cersosimo, MD,PhD, The University of Texas Health Science Center at San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eugenio Cersosimo, Associate Professor, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT02981966
    Other Study ID Numbers:
    • HSC20160596H
    First Posted:
    Dec 5, 2016
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Dapagliflozin

    Study Results

    No Results Posted as of Aug 10, 2022