Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action (DAPA MITO)
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ClinicalTrials.gov Identifier: NCT01439854 |
Recruitment Status :
Completed
First Posted : September 23, 2011
Last Update Posted : July 10, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insulin Sensitivity Multiple Mitochondrial Dysfunctions Syndrome | Drug: Dapagliflozin Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | 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 |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | June 30, 2018 |
Actual Study Completion Date : | June 30, 2018 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
this arm is control
|
Drug: Placebo
Patients are treated with placebo |
Experimental: Dapagliflozin
Interventional arm
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Drug: Dapagliflozin
Treatment arm, 10 mg per day for 2 weeks |
- Change in Insulin Sensitivity [ Time Frame: baseline, two weeks ]The change in insulin sensitivity and total glucose disposal measured at two weeks with the insulin clamp compared to baseline.
- Change in Mitochondrial Function [ Time Frame: baseline, two weeks ]The change in mitochondrial function/gene expression at two weeks compared to baseline.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- T2DM
- Drug Naive Or On Oral Therapy
Exclusion Criteria:
- Insulin Treatment
- Major Organ Disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439854
United States, Texas | |
Diabetes Division, UTHSCSA | |
San Antonio, Texas, United States, 78229 |
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 |
Responsible Party: | Ralph DeFronzo, Professor, Medicine -Diabetes, The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT01439854 History of Changes |
Other Study ID Numbers: |
5 R01 DK024092-27/NIH Prot IV R01DK024092 ( U.S. NIH Grant/Contract ) |
First Posted: | September 23, 2011 Key Record Dates |
Last Update Posted: | July 10, 2018 |
Last Verified: | July 2018 |
Keywords provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:
Insulin sensitivity Mitochondrial function Glucose toxicity Glucosuria |
Additional relevant MeSH terms:
Hypersensitivity Insulin Resistance Mitochondrial Diseases Immune System Diseases Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs |