N/A
N=18
Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action
Insulin Sensitivity · Multiple Mitochondrial Dysfunctions Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01439854 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Insulin Sensitivity — 3.18; 3.85; 3.57; 5.22 mg/kg.min per µU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dapagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Sensitivity |
3.18; 3.85; 3.57; 5.22 | — |
| SECONDARY Change in Mitochondrial Function |
1.06; 1.3; 1.0; 1.34 | — |
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].
Eligibility Criteria
Inclusion Criteria
- T2DM
- Drug Naive Or On Oral Therapy
Exclusion Criteria
- Insulin Treatment
- Major Organ Disease
Data sourced from ClinicalTrials.gov (NCT01439854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.