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.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2026/007

Enrollment

Unknown

Registered

2026-03-13

Start date

2026-03-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion-Dependent beta-thalassemia with Diabetes

Interventions

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 recei

Eligibility

Inclusion criteria

Inclusion criteria: - Patients aged >12 years <45 years with confirmed transfusion-dependent beta-thalassemia patients - Diabetes mellitus diagnosed by fasting plasma glucose (FPG) or oral glucose tolerance test (OGTT) criteria - Stable transfusion schedule and iron-chelation regimen for ?8 weeks prior to enrolment - eGFR <30 mL/min/1.73 m² (consider ?45 mL/min/1.73 m² if preferred by clinician)

Exclusion criteria

Exclusion criteria: - History of recent DKA within the preceding 6 months - Recurrent or complicated genitourinary infections - Pregnancy or lactation; planned major surgery or prolonged fasting during the study period. - Decompensated liver disease (Child-Pugh B/C) or active nephrolithiasis - Anticipated modification in transfusion or chelation protocol within the first 12 weeks

Design outcomes

Primary

Measure	Time frame
Change in albumin-corrected fructosamine (FRAc) [Baseline (week 0) and 12 weeks from baseline ]	—

Secondary

Measure	Time frame
albumin-corrected fructosamine (FRAc) and serum albumin levels [weeks 0, 4, 8, 24, and 52] Fasting plasma glucose [ weeks 0,4,8 and 12] Serum Ferritin, CRP and Transfusion data [ week 0,12] Renal out comes with eGFR, ACR, uric acid [ week 0,12,24 and 52] Hepatic outcomes with AST, ALT [ week 0,12,24 and 52] Transient Elastography of the Liver (FibroScan®) [ week 0,24,52] Haemaotological outcomes with full blood count [ week 0, 8,12]	—

Measure

Time frame

albumin-corrected fructosamine (FRAc) and serum albumin levels [weeks 0, 4, 8, 24, and 52] Fasting plasma glucose [ weeks 0,4,8 and 12] Serum Ferritin, CRP and Transfusion data [ week 0,12] Renal out comes with eGFR, ACR, uric acid [ week 0,12,24 and 52] Hepatic outcomes with AST, ALT [ week 0,12,24 and 52] Transient Elastography of the Liver (FibroScan®) [ week 0,24,52] Haemaotological outcomes with full blood count [ week 0, 8,12]

—

Countries

Sri Lanka

Contacts

Public ContactDr. Dulani C Kottahachchi

Senior Lecturer (Grade II), Consultant Endocrinologist

dulanik@kln.ac.lk+94 11 2961000

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026