Home » Trials » SLCTR/2024/030
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes: START Trial
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SLCTR Registration Number
SLCTR/2024/030
Date of Registration
The date of last modification
Nov 11, 2024
Scientific Title of Trial
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes: START Trial
Public Title of Trial
Effect of SGLT2 Inhibitor (Dapagliflozin) versus Metformin on Renal Decline when used as First Line Therapy in People with Type 2 Diabetes
Disease or Health Condition(s) Studied
Type 2 Diabetes
Scientific Acronym
START
Public Acronym
START
Brief title
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Universal Trial Number
UTC: U1111-1306-6040
Any other number(s) assigned to the trial and issuing authority
ClinicalTrials.gov Identifier: NCT05345327
What is the research question being addressed?
Is the SGLT2 inhibitor, dapagliflozin, more effective compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers, Outcome assessors
Control
Active
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 3
Intervention(s) planned
Study sites in Sri Lanka: • The National Hospital of Sri Lanka • Kandy National Hospital • Karapitiya Teaching Hospital • Jaffna Teaching Hospital
Intervention: Single-blind 4-week active run-in period to assess adherence and tolerability of study medication. Following completion of run-in, participants who tolerated and adhered to the run-in medication will be randomized.
Randomization: Participants will be randomly allocated (via a web-based system) in a 1:1 ratio to either metformin XR or dapagliflozin, stratified by site and baseline renal function.
Study arms: 1. Experimental: 10mg Dapagliflozin and Metformin placebo daily for 2 years. 2. Active Comparator: 2000mg Metformin XR and Dapagliflozin placebo daily for 2 years.
Randomized study medication will be provided in identical packaging such that participants and study staff are masked to treatment allocation.
Inclusion criteria
•Diagnosis of T2D (As this is a pragmatic trial, specific diagnostic criteria for type 2 diabetes are not mandated. Participants diagnosed with type 2 diabetes according to standard clinical practice of the participating clinics will be eligible for this trial) •Males and females 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 >= 30 ml/min/1.73m^2;
Exclusion criteria
•Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; •There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor (as outlined in the current versions of the product information) •They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) Clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); •Pregnant or breast-feeding.
Primary outcome(s)
|
1.
Rate of decline in eGFR (The rate of decline in eGFR, defined as change in eGFR from study baseline to 24 months, in ml/min/1.73m2/year) |
[ Ongoing, up to 24 months ] |
Secondary outcome(s)
|
1.
Change in urine albumin creatinine ratio |
[ Ongoing, up to 24 months ] |
|
2.
Change in serum creatinine |
[ Ongoing, up to 24 months ] |
|
3.
HbA1C |
[ Ongoing, up to 24 months ] |
|
4.
Fasting blood glucose |
[ Ongoing, up to 24 months ] |
|
5.
Systolic and diastolic blood pressure |
[ Ongoing, up to 24 months ] |
|
6.
Body weight |
[ Ongoing, up to 24 months ] |
|
7.
Quality of life measured by EQ-5D-5L. |
[ Ongoing, up to 24 months ] |
|
8.
Anxiety and depression symptoms measured by HADS |
[ Ongoing, up to 24 months ] |
Target number/sample size
Global: 994, Sri Lanka: 400
Countries of recruitment
Australia, Sri Lanka
Anticipated start date
2024-09-16
Anticipated end date
2026-09-30
Date of first enrollment
2024-10-31
Date of study completion
Recruitment status
Recruiting
Funding source
National Health and Medical Research Council (NHMRC) 2020 Clinical Trials and Cohort Studies Grant, APP2006893
Regulatory approvals
Approved by National Medicines Regulatory Authority, Sri Lanka
Status
Approved
Date of Approval
2024-04-09
Approval number
P/19/02/2024
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Manilka Sumanatilleke
Consultant Endocrinologist
National Hospital of Sri Lanka
+94777440208
manilkasumana@gmail.com
Contact Person for Public Queries
Dr. Manilka Sumanatilleke
Consultant Endocrinologist
National Hospital of Sri Lanka
+94777440208
manilkasumana@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
N/A
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
