NCT02592421

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Typical duration for phase_3

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

October 14, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

October 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 18, 2019

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

October 14, 2015

Results QC Date

November 13, 2019

Last Update Submit

September 15, 2020

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change in Plasma Glucose Concentration

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

    Baseline to 240-300 minutes

  • Change in Endogenous Glucose Production (EGP)

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

    Baseline to 240-300 minutes

Secondary Outcomes (2)

  • Change in Plasma Insulin During Measurement of EGP

    Baseline to 240-300 minutes

  • Change in Glucagon During EGP Measurement

    Baseline to 240-300 minutes

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

20 subjects will receive dapagliflozin 10mg

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

10 subjects will receive placebo

Drug: Placebo

Interventions

DapagliflozinDRUG

SGLT2 inhibitor (dapagliflozin)

Also known as: Farxiga
Dapagliflozin
PlaceboDRUG

Placebo Comparator

Placebo

Eligibility Criteria

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

You may qualify if:

  • T2DM subjects
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Alatrach M, Laichuthai N, Martinez R, Agyin C, Ali AM, Al-Jobori H, Lavynenko O, Adams J, Triplitt C, DeFronzo R, Cersosimo E, Abdul-Ghani M. Evidence Against an Important Role of Plasma Insulin and Glucagon Concentrations in the Increase in EGP Caused by SGLT2 Inhibitors. Diabetes. 2020 Apr;69(4):681-688. doi: 10.2337/db19-0770. Epub 2020 Jan 8.

    PMID: 31915153DERIVED

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
Organization
University of Texas Health San Antonio
defronzo@uthscsa.edu
210-567-6691

Study Officials

  • Ralph A. DeFronzo, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 30, 2015

Study Start

October 23, 2015

Primary Completion

October 1, 2018

Study Completion

October 31, 2019

Last Updated

September 17, 2020

Results First Posted

December 18, 2019

Record last verified: 2020-09

Locations

US(1)