Clinical trial NCT05345327: SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Official title: SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes
Renal decline
Metformin
Sodium Glucose Co-Transporter 2 inhibitor
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: The University of New South Wales
name: Monash University
name: University of Sydney
First posted: 2022-04-25
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.

Detailed description: This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2D;
* Aged ≥18 years;
* Body mass index \> 18.5 kg/m2;
* Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;
* eGFR ≥45 ml/min/1,73m2; and
* Signed informed consent.

Exclusion Criteria:

* Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
* There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or
* They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or
* Pregnant or breast-feeding.

Primary outcomes:
measure: Rate of decline in eGFR
timeFrame: 24 months
Secondary outcomes:
measure: Urine albumin creatinine ratio
timeFrame: 24 months
measure: Serum creatinine
timeFrame: 24 months
measure: HbA1C
timeFrame: 24 months
measure: Fasting blood glucose
timeFrame: 24 months
measure: Systolic and diastolic blood pressure
timeFrame: 24 months
measure: Body weight
timeFrame: 24 months
measure: Quality of life measured by EQ-5D-5L
timeFrame: 24 months
measure: Anxiety and depression symptoms measured by HADS
timeFrame: 24 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The George Institute for Global Health
state: New South Wales
city: Brisbane
country: Australia
facility: The George Institute for Global Health
state: Queensland
city: Melbourne
country: Australia
facility: Monash University
state: Victoria
city: Galle
country: Sri Lanka
facility: National Hospital - Galle
state: Southern Province
city: Colombo 10
country: Sri Lanka
facility: National Hospital of Sri Lanka 1
city: Colombo
country: Sri Lanka
facility: National Hospital of Sri Lanka 2
city: Jaffna
country: Sri Lanka
facility: Jaffna Teaching Hospital
city: Kandy
country: Sri Lanka
facility: Kandy National Hospital
Study officials:
affiliation: The George Institute for Global Health (Sydney, Australia)
name: Bruce Neal
role: STUDY_CHAIR
affiliation: The George Institute for Global Health (Sydney, Australia)
name: Clare Arnott
role: STUDY_CHAIR
References: