RecruitingPhase 3NCT05345327
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Sponsor
The George Institute
Enrollment
994 participants
Start Date
Jan 1, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria4
- 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.
Interventions
DRUGDapagliflozin
SGLT2 inhibitor
DRUGMetformin
Metformin
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05345327
Related Trials
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
NCT0729648446 locations
Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care
NCT071694221 location
Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes
NCT068364791 location
High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes
NCT066884611 location
Exercise and Protein Efficiency in T2D
NCT074770671 location