Home » Trials » SLCTR/2026/007
A Randomised Double-Blind, Placebo-Controlled (Superiority) Trial Using an SGLT2 Inhibitor as a Metabolic and Erythropoietin Modulator in Transfusion-Dependent beta-thalassemia Patients with Diabetes
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SLCTR Registration Number
SLCTR/2026/007
Date of Registration
The date of last modification
Mar 13, 2026
Scientific Title of Trial
A Randomised Double-Blind, Placebo-Controlled (Superiority) Trial Using an SGLT2 Inhibitor as a Metabolic and Erythropoietin Modulator in Transfusion-Dependent beta-thalassemia Patients with Diabetes
Public Title of Trial
A Randomised Double-Blind, Placebo-Controlled (Superiority) Trial Using a Sodium-Glucose Co-Transporter 2 Inhibitor as a Metabolic and Erythropoietin Modulator in Transfusion-Dependent Beta-Thalassemia Patients with Diabetes.
Disease or Health Condition(s) Studied
Transfusion-Dependent beta-thalassemia with Diabetes
Scientific Acronym
EMPA-THAL-DM trial
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1332-9198
Any other number(s) assigned to the trial and issuing authority
P/240/11/2025: ERC, FoM, UoK
What is the research question being addressed?
Do sodium-glucose co-transporter 2 inhibitors act as a metabolic and erythropoietin modulator in transfusion-dependent beta-thalassemia with diabetes compared to a placebo?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: Adolescent and Adult Thalassaemia Care Center (University Medical Unit), North Colombo Teaching Hospital,
Randomisation: Participants will be randomly assigned in a 1:1 ratio to receive either: Randomization method: Participants will be randomly assigned using a computer-generated randomization sequence.
Sequence Detail: The sequence will be prepared by an independent statistician using variable block sizes.
Concealment: Allocation will be concealed through the use of sequentially numbered, opaque, sealed envelopes
Intervention Intervention arm: An SGLT2 inhibitor (Empagliflozin) is administered orally at a standard approved dose for diabetes mellitus. Given once daily in addition to standard care for diabetes and transfusion-dependent beta-thalassemia. Duration of intervention is 52 weeks
Comparator arm: Matching placebo containing lactose, administered orally once daily given in addition to standard care for diabetes and transfusion-dependent beta-thalassemia. Duration identical to the intervention arm.
The following parties will be blinded to the treatment assignment: ? Participants ? Investigators ? Clinical staff Note: To maintain this blinding, the intervention (Empagliflozin 10 mg) and the matching placebo are designed with identical packaging and appearance
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in albumin-corrected fructosamine (FRAc) |
[ Baseline (week 0) and 12 weeks from baseline ] |
Secondary outcome(s)
|
1.
albumin-corrected fructosamine (FRAc) and serum albumin levels |
[ weeks 0, 4, 8, 24, and 52 ] |
|
2.
Fasting plasma glucose |
[ weeks 0,4,8 and 12 ] |
|
3.
Serum Ferritin, CRP and Transfusion data |
[ week 0,12 ] |
|
4.
Renal out comes with eGFR, ACR, uric acid |
[ week 0,12,24 and 52 ] |
|
5.
Hepatic outcomes with AST, ALT |
[ week 0,12,24 and 52 ] |
|
6.
Transient Elastography of the Liver (FibroScan®) |
[ week 0,24,52 ] |
|
7.
Haemaotological outcomes with full blood count |
[ week 0, 8,12 ] |
Target number/sample size
70 (35 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2026-03-14
Anticipated end date
2027-03-14
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
NA
Status
Approved
Date of Approval
2026-01-13
Approval number
P/240/11/2025
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: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. Dulani C Kottahachchi
Senior Lecturer (Grade II), Consultant Endocrinologist
Department of Physiology,Faculty of Medicine, University of Kelaniya, Sri Lanka.
+94 11 2961000
0777481632
dulanik@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-dulani-c-kottahachchi.html
Contact Person for Public Queries
Dr. Dulani C Kottahachchi
Senior Lecturer (Grade II), Consultant Endocrinologist
Department of Physiology,Faculty of Medicine, University of Kelaniya, Sri Lanka.
+94 11 2961000
0777481632
dulanik@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-dulani-c-kottahachchi.html
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
version 02, 12/12/2025
Protocol URL
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
