NCT02981966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started May 2019

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
6 days until next milestone

Results Posted

Study results publicly available

June 6, 2023

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

November 30, 2016

Results QC Date

May 10, 2023

Last Update Submit

February 28, 2024

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Endogenous Glucose Production Measurement

    Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.

    3 weeks

Secondary Outcomes (1)

  • Renal Glucose Production Measurement of Change

    Baseline to 3 weeks

Study Arms (4)

T2DM individuals on Dapagliflozin

ACTIVE COMPARATOR

Individuals with type 2 diabetes mellitus - dapagliflozin

Drug: Dapagliflozin

T2DM individuals on Placebo

PLACEBO COMPARATOR

Individuals with type 2 diabetes mellitus on placebo

Drug: Placebo

Normal Glucose Tolerance (NGT) on Dapagliflozin

ACTIVE COMPARATOR

Individuals with normal glucose tolerance - dapagliflozin

Drug: Dapagliflozin

Normal Glucose Tolerance (NGT) Placebo

PLACEBO COMPARATOR

Individuals with normal glucose tolerance - on placebo

Drug: Placebo

Interventions

DapagliflozinDRUG

dapagliflozin, 10mg tablet

Also known as: Farxiga
Normal Glucose Tolerance (NGT) on DapagliflozinT2DM individuals on Dapagliflozin
PlaceboDRUG

Placebo for dapagliflozin

Normal Glucose Tolerance (NGT) PlaceboT2DM individuals on Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Ralph DeFronzo, MD
Organization
UTexas_SanAntonio
defronzo@uthscsa.edu
210-567-6691

Study Officials

  • Eugenio Cersosimo, MD,PhD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

May 23, 2019

Primary Completion

April 30, 2022

Study Completion

May 31, 2023

Last Updated

March 4, 2024

Results First Posted

June 6, 2023

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)