Comparison among SGLT-2 inhibitors in elderly patients with type 2 diabetes.

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. - GOLDEN-AGE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001167-24-IT

Enrollment

1167

Registered

2021-08-17

Start date

2021-11-04

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Type 2 diabetes mellitus MedDRA version: 21.1 Level: LLT Classification code 10045252 Term: Type II diabetes mellitus without mention of complication System Organ Class: 100000004861

Interventions

Product Name: Dapagliflozin Product Code: [Dapagliflozin] Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DAPAGLIFLOZIN Current Sponsor code: Dapagliflozin Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Type 2 diabetes - Age =70 years - Men or women - Established cardiovascular disease (symptomatic or asymptomatic) or eGFR =65 years) yes F.1.3.1 Number of subjects for this age range 1167

Exclusion criteria

Exclusion criteria: - Age> 90 years - Estimated life expectancy 5% in <6 months) - Participation in another interventional drug trial - Inability to give written informed consent - Intolerance to lactose and any other contraindication to the study drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-3 hypoglycaemia at the end of the study at 24 months0;Secondary Objective: The primary secondary objective will be to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-2 hypoglycemia at any time during the observation. Other secondary objectives include the intra-class comparison of several study endpoints: Change in HbA1c level, in body weight, in systolic blood pressure, in e-GFR, in urinary albumin excretion rate in concomitant medications and their daily dosages, in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ), Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients), including BNP, beta-crosslaps, acid phosphatase, alkaline phosphatase, serum calcium, serum phosphorus, osteocalcin.;Primary end point(s): Glucose control without level-3 hypoglycemia;Timepoint(s) of evaluation of this end point: At any time during observation	—

Measure

Time frame

Main Objective: The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-3 hypoglycaemia at the end of the study at 24 months0;Secondary Objective: The primary secondary objective will be to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-2 hypoglycemia at any time during the observation. Other secondary objectives include the intra-class comparison of several study endpoints: Change in HbA1c level, in body weight, in systolic blood pressure, in e-GFR, in urinary albumin excretion rate in concomitant medications and their daily dosages, in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ), Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients), including BNP, beta-crosslaps, acid phosphatase, alkaline phosphatase, serum calcium, serum phosphorus, osteocalcin.;Primary end point(s): Glucose control without level-3 hypoglycemia;Timepoint(s) of evaluation of this end point: At any time during observation

—

Secondary

Measure	Time frame
Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: At any time during observation; Mean least square difference at 24 months; Mean least square difference at 24 months; Mean least square difference at 24 months; Mean least square difference at 24 months; Mean least square difference at the end of observation; At 24 months; Mean least square difference at 24 months; Mean least square difference at 24 months; At 24 months	—

Measure

Time frame

Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: At any time during observation; Mean least square difference at 24 months; Mean least square difference at 24 months; Mean least square difference at 24 months; Mean least square difference at 24 months; Mean least square difference at the end of observation; At 24 months; Mean least square difference at 24 months; Mean least square difference at 24 months; At 24 months

—

Countries

Italy

Contacts

Public ContactSegreteria

SID

a.russo@siditalia.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026