NCT04401904: SGLT2i

SGLT2 Inhibition in Older Obese Adults With Pre-diabetes

Completed Phase 1, PHASE2 Results posted Last updated 5 January 2024

What this trial tests

Phase 1, PHASE2 trial testing Dapagliflozin 10 mg in Aging in 20 participants. Completed in 14 September 2022.

Timeline

25 June 2020

Primary endpoint
14 September 2022

14 September 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	25 June 2020
Primary completion	14 September 2022
Estimated completion	14 September 2022
Sites	2 locations across United States

Drugs / interventions tested

• Dapagliflozin 10 mg — full drug profile →
• Nutritional counseling

Conditions studied

• Aging — all drugs for Aging →

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

60 and older, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

AGE-RAGE Measurement in Plasma Primary · Baseline to 12 weeks

Change in AGE-RAGE measured by enzyme-linked immunosorbent assay (ELISA).

Group	Value	95% CI
Dapagliflozin	-172	± 121
Nutritional Counseling	-86	± 112

Grip Strength Secondary · Baseline to 12 weeks

Change in grip strength measured using a hand-held dynamometer in Newton meters (Nm)

Group	Value	95% CI
Dapagliflozin	-2	± 1.3
Nutritional Counseling	-1	± 1.2

6 Minute Walking Distance Secondary · Baseline to 12 weeks

Change in walking distance in the 6 minute walking test.

Group	Value	95% CI
Dapagliflozin	6.6	± 7.6
Nutritional Counseling	9.1	± 11.8

Sponsor's own description

Inhibitors of the sodium-glucose co-transporter (SGLT2) are FDA-approved for the treatment of type 2 diabetes (T2DM). Their mechanism of action involves lowering of blood glucose concentration secondary to increased glucose excretion of glucose by the kidney. These drugs also improve body weight, blood pressure, and cardiac function. Based on these pleiotropic effects, including its calorie restriction-mimetic properties, the study team hypothesize that SGLT2 drugs will impact several basic aging-related processes, including reductions in oxidative damage to DNA and proteins, advanced glycation end products (AGE) and receptor for AGE (RAGE), cellular senescence, and mitochondrial function.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Role of mitochondria in physiological activities, diseases, and therapy.
   Wang L, Zhou X, Lu T. · · 2025 · cited 23× · PMID 40536597 · DOI 10.1186/s43556-025-00284-5