Trial Outcomes & Findings for Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action (NCT NCT01439854)

Last Updated: 2025-07-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

baseline, two weeks

Results posted on

2025-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo this arm is control Placebo: Patients are treated with placebo	Dapagliflozin Interventional arm Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks
Overall Study STARTED	8	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants this arm is control Placebo: Patients are treated with placebo	Dapagliflozin n=10 Participants Interventional arm Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks	Total n=18 Participants Total of all reporting groups
Age, Continuous	55.4 Years STANDARD_DEVIATION 2.1 • n=5 Participants	51.9 Years STANDARD_DEVIATION 2.3 • n=7 Participants	53.6 Years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants
Body Mass Index (BMI)	32.6 kg/m^2 STANDARD_DEVIATION 1.5 • n=5 Participants	30.9 kg/m^2 STANDARD_DEVIATION 1.8 • n=7 Participants	31.8 kg/m^2 STANDARD_DEVIATION 1.7 • n=5 Participants
A1C (average blood glucose level over 3 months	8.7 percentage STANDARD_DEVIATION 0.4 • n=5 Participants	8.5 percentage STANDARD_DEVIATION 0.4 • n=7 Participants	8.6 percentage STANDARD_DEVIATION 0.4 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, two weeks

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants this arm is control Placebo: Patients are treated with placebo	Dapagliflozin n=10 Participants Interventional arm Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks
Change in Insulin Sensitivity Baseline Measurement	3.18 mg/kg.min per µU/ml Standard Deviation 0.51	3.85 mg/kg.min per µU/ml Standard Deviation 0.71
Change in Insulin Sensitivity 2 weeks	3.57 mg/kg.min per µU/ml Standard Deviation 0.51	5.22 mg/kg.min per µU/ml Standard Deviation 0.56

SECONDARY outcome

Timeframe: baseline, two weeks

The change in mitochondrial function/gene expression at two weeks compared to baseline. This was measured by energy expenditure.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants this arm is control Placebo: Patients are treated with placebo	Dapagliflozin n=10 Participants Interventional arm Dapagliflozin: Treatment arm, 10 mg per day for 2 weeks
Change in Mitochondrial Function Baseline Measurement	1.06 cal/min.kg Standard Deviation 0.1	1.3 cal/min.kg Standard Deviation 0.1
Change in Mitochondrial Function Measurement at 2 weeks	1.0 cal/min.kg Standard Deviation 0.1	1.34 cal/min.kg Standard Deviation 0.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dapagliflozin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Muhammad Abdul-Ghani

University of Texas Health San Antonio

Phone: 210-557-1157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place