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Intraclass safety and efficacy comparison among SGLT-2 inhibitors in elderly patients with type 2 diabetes. A pragmatic, phase IV, multicenter, open-label, randomised controlled trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518915-20-00
Acronym
TRS-2019-00002051
Enrollment
1167
Registered
2024-11-13
Start date
2022-02-16
Completion date
2025-10-02
Last updated
2025-09-30

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

Conditions

Type 2 diabetes mellitus

Brief summary

Glucose control without level-3 hypoglycemia

Detailed description

Glucose control without level-2 hypoglycemia, Change in HbA1c glycemic and extraglycemic endpoints, Change in HbA1c, Change in body weight, Change in systolic blood pressure, Change in eGFR, Change in the use of concomitant medications, Change in the dosage of concomitant medications, Change in treatment satisfaction, Safety: - Hospitalization for any cause, - Hospitalization for heart failure, - Hospitalization for cardiovascular causes, - All-cause death - Cardiovascular death - Severe hypoglycemia - Genitourinary tract infections - Dehydration / hypovolemia events - Bone fractures; - Leg/foot amputations - Diabetic ketoacidosis

Interventions

DRUGInvokana 100 mg film-coated tablets
DRUGXigduo 5 mg/850 mg film-coated tablets
DRUGVokanamet 150 mg/850 mg film-coated tablets
DRUGForxiga 10 mg film-coated tablets
DRUGVokanamet 50 mg/1
DRUG000 mg film-coated tablets
DRUGInvokana 300 mg film-coated tablets
DRUGForxiga 5 mg film-coated tablets
DRUGVokanamet 50 mg/850 mg film-coated tablets
DRUGSynjardy 12.5 mg/1
DRUGSynjardy 12.5 mg/850 mg film-coated tablets
DRUGJardiance 25 mg film-coated tablets
DRUGSynjardy 5 mg/1
DRUGXigduo 5 mg/1
DRUGSynjardy 5 mg/850 mg film-coated tablets
DRUGVokanamet 150 mg/1
DRUGJardiance 10 mg film-coated tablets

Sponsors

Center For Outcomes Research And Clinical Epidemiology S.r.l.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Glucose control without level-3 hypoglycemia—

Secondary

MeasureTime frame
Glucose control without level-2 hypoglycemia, Change in HbA1c glycemic and extraglycemic endpoints, Change in HbA1c, Change in body weight, Change in systolic blood pressure, Change in eGFR, Change in the use of concomitant medications, Change in the dosage of concomitant medications, Change in treatment satisfaction, Safety: - Hospitalization for any cause, - Hospitalization for heart failure, - Hospitalization for cardiovascular causes, - All-cause death - Cardiovascular death - Severe hypoglycemia - Genitourinary tract infections - Dehydration / hypovolemia events - Bone fractures; - Leg/foot amputations - Diabetic ketoacidosis—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026