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To study and know the efficiency of the anti- diabetic drug Metformin in patients who develop high blood sugar levels during the treatment phase of acute leukemia or blood cancer since they receive high dose steroids which causes high blood sugar levels.

To study the efficacy of Metformin as an anti-hyperglycemic agent in patients requiring Insulin therapy during the induction phase of Acute Lymphoblastic Leukemia treatment - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060401
Enrollment
50
Registered
2023-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: METFORMIN: Metformin will be given at the dose of 500 mg per Oral twice daily for 1 week followed by 1 g per oral twice daily for next week. Total duration of therapy is 14 days. Contr

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Treatment-naïve, newly diagnosed adults (= 18 years of age) with ALL requiring Insulin therapy for hyperglycemia during first 14 days of Induction chemotherapy, coming to the Department of Hematology after the Ethical approval for the study is granted, and providing informed consent for inclusion in the study, will be included in the study.

Exclusion criteria

Exclusion criteria: Known case or newly diagnosed Diabetic individuals or Already on Metformin therapy or with Contra-Indications to Metformin therapy

Design outcomes

Primary

MeasureTime frame
To study the efficacy of Metformin as the anti-hyperglycemic agent during the Induction therapy in ALL patients by assessing the change/reduction in daily Insulin requirement.Timepoint: End of Induction therapy

Secondary

MeasureTime frame
To know the effect of metformin on End of Induction Measurable residual disease by comparing it with Measurable residual disease of Patients who didn’t receive Metformin.Timepoint: End of Induction therapy

Countries

India

Contacts

Public ContactAniruddha Burli

All India Institute of Medical Sciences

mukulmamc@gmail.com9035572627

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026