Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action
DAPA MITO
Regulation of Hepatic and Peripheral Glucose Metabolism: Protocol IVA. Effect of Plasma Glucose Reduction by Selective SLGT2 Inhibition on Mitochondrial Dysfunction and Impaired Insulin Signaling/Sensitivity in T2DM
2 other identifiers
interventional
18
1 country
1
Brief Summary
The purpose of this study is to examine the effect of the chronic treatment of type 2 diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and insulin signaling/action and (2) oral glucose tolerance and beta cell function. Dapagliflozin is a potent, highly specific inhibitor of renal glucose transport \[SGLT2\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 3, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedResults Posted
Study results publicly available
October 29, 2019
CompletedJuly 3, 2025
June 1, 2025
7.3 years
August 3, 2011
September 16, 2019
June 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Insulin Sensitivity
The change in insulin sensitivity and total glucose disposal measured at two weeks with the insulin clamp compared to baseline. This is measured using TGD (whole body tissue glucose disposal)/SSPI (steady state plasma insulin concentration) ratio
baseline, two weeks
Secondary Outcomes (1)
Change in Mitochondrial Function
baseline, two weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORthis arm is control
Dapagliflozin
EXPERIMENTALInterventional arm
Interventions
Eligibility Criteria
You may qualify if:
- T2DM
- Drug Naive Or On Oral Therapy
You may not qualify if:
- Insulin Treatment
- Major Organ Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Division, UTHSCSA
San Antonio, Texas, 78229, United States
Related Publications (1)
Daniele G, Xiong J, Solis-Herrera C, Merovci A, Eldor R, Tripathy D, DeFronzo RA, Norton L, Abdul-Ghani M. Dapagliflozin Enhances Fat Oxidation and Ketone Production in Patients With Type 2 Diabetes. Diabetes Care. 2016 Nov;39(11):2036-2041. doi: 10.2337/dc15-2688. Epub 2016 Aug 25.
PMID: 27561923RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Muhammad Abdul-Ghani
- Organization
- University of Texas Health San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph DeFronzo, MD
The University of Texas Health Science Center at San Antonio
- PRINCIPAL INVESTIGATOR
Devjit Tripathy, MD
The University of Texas Health Science Center at San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2011
First Posted
September 23, 2011
Study Start
March 1, 2011
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
July 3, 2025
Results First Posted
October 29, 2019
Record last verified: 2025-06