GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial

Diabetes Mellitus, Type 2 Clinical Trial

— GOLDEN-AGE  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04796428
• Other study ID #: TRS-2019-00002051
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Center for Outcomes Research and Clinical Epidemiology, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Three SGLT2i were commercially available in Italy at the time the trial was designed: canagliflozin, dapagliflozin, and empagliflozin. Preliminary evidence suggests that the higher dose canagliflozin (300 mg/day) might exert a stronger glucose-lowering effect than dapagliflozin or empagliflozin. The clinical relevance of this putative difference is however unknown. On the other side, the use of canagliflozin, but not empagliflozin and dapagliflozin, has been associated with an increased risk of some adverse events, namely bone fractures and lower limb amputations. Currently, the available information on the efficacy and safety of SGLT2i in elderly (70+ years) patients with type 2 diabetes are is very scant. Thus, a compelling need now exists of comparing efficacy and safety of the commercially available SGLT2i in a population of frail patients at high risk of cardiovascular and renal diseases.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1167
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Age 70+ years

• Male or female

• Prevalent cardiovascular disease (symptomatic or asymptomatic) or eGFR <90 ml/min/1.73 m2 and above the lower limit for initiation of SGLT2i according to label (currently eGFR <60 ml/min/1.73 m2)

• HbA1c above individualized target

• Indication to add SGLT2i

Exclusion Criteria:

• Age >90 years

• Estimated life expectancy <1 year

• Very high risk of genitourinary tract infections (>2 events in the last 6 months)

• Recent weight loss (>5% in <6 months)

• Inability to provide informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Canagliflozin
Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.
• Dapagliflozin
Dapagliflozin If the patient is already on metformin, the fixed combination dapagliflozin / metformin can be used. If the patient is already on a DPP-4 inhibitor, the fixed dose combination dapagliflozin / saxagliptin can be used.
• Empagliflozin
If the patient is already on metformin, the fixed combination empagliflozin / metformin can be used. If the patient is already on a DPP-4 inhibitor, the fixed dose combination empagliflozin / linagliptin can be used.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Center for Outcomes Research and Clinical Epidemiology, Italy	Italian Society of Diabetology

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Objectives	Hospitalization for any cause	Up to 24 months
Other	Safety Objectives	Hospitalization for heart failure and/or cardiovascular causes	Up to 24 months
Other	Safety Objectives	All-cause death and Cardiovascular death	Up to 24 months
Other	Safety Objectives	Severe hypoglycemia	Up to 24 months
Other	Safety Objectives	Genitourinary tract infections	Up to 24 months
Other	Safety Objectives	Dehydration / hypovolemia events	Up to 24 months
Other	Safety Objectives	Bone fractures	Up to 24 months
Other	Safety Objectives	Leg/foot amputations	Up to 24 months
Other	Safety Objectives	Diabetic ketoacidosis	Up to 24 months
Primary	Primary Objective	The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-2 hypoglycaemia.	Up to 24 months
Secondary	Secondary Objectives - HbA1c	Change in HbA1c level (as a continuous variable) - %	Up to 24 months
Secondary	Secondary Objectives - body weight	Change in body weight (as a continuous variable) - Kg	Up to 24 months
Secondary	Secondary Objectives - systolic blood pressure	Change in systolic blood pressure (as a continuous variable) - mmHG	Up to 24 months
Secondary	Secondary Objectives - e-GFR	Change in e-GFR (as a continuous variable). The slope of eGFR decline will be calculated over time in the three treated groups - mL/min	Up to 24 months
Secondary	Secondary Objectives - urinary albumin excretion rate	Change in urinary albumin excretion rate (as a continuous variable) - mg/L	Up to 24 months
Secondary	Secondary Objectives - medications	Change concomitant medications and their daily dosages	Up to 24 months
Secondary	Secondary Objectives - treatment satisfaction	Change in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ).	Up to 24 months
Secondary	Secondary Objectives - biomarkers	Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients) with physiological parameter	Up to 24 months