Skip to content

The impact of the SGLT2 inhibitor on cardiovascular risk factors in patients with type 2 diabetes, an explanatory randomized trial

The impact of the SGLT2 inhibitor on cardiovascular risk factors in patients with type 2 diabetes, an explanatory randomized trial - The impact of the SGLT2 inhibitor on cardiovascular risk factors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021669
Enrollment
60
Registered
2016-04-01
Start date
2016-04-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

8 weeks administration of Empagliflozin 10mg q.d. Standard care

Sponsors

Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HbA1c >= 7.0% and HbA1c < 10%

Exclusion criteria

Exclusion criteria: 1. Diagnosed as diabetes within the last 6 months 2. Taking SGLT2 inhibitors 3. Taking diuretics 4. Pituitary dysfunction or adrenal insufficiency 5. Excessive alcohol intake 8. eGFR < 30mL / min / 1.73m2(MDRD) 9. AST >= 165 or ALT >= 210 10. Serum C-peptide < 0.5ng / mL 11. History of severe hypoglycemia within the last 3 months 12. Systolic blood pressure >= 200 mmHg or diastolic blood pressure >=120 mmHg 13. Secondary hypertension 14. Vitreous hemorrhage, unstable proliferative diabetic retinopathy 15. Severe diabetic neuropathy 16. Positive anti-GAD antibody 17. During pregnancy 18. Chronic atrial fibrillation 19. History of pyelonephritis 20. Claustrophobia, pacemaker, the metal in the body, weighing 150 kg or more 21. Unable to hold the breath longer than 20 seconds

Design outcomes

Primary

MeasureTime frame
Intramyocardial lipid deposition measured by magnetic resonance spectroscopy (MRS): Time Frame of 8 weeks

Countries

Japan

Contacts

Public ContactKazuo Hara

Tokyo Medical University Division of Diabetes, Endocrinology and Metabolism

hara@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026