Treatment of high blood sugars in children on treatment for blood cancer- Insulin vs Insulin plus metformin ( Both ae medicines used to treat high blood sugar)

Drug induced Diabetes Mellitus management in children with Acute Lymphoblastic Leukemia (ALL) â?? A Phase-2 Open-Label Randomized Control Trial (RCT) comparing two treatment arms (Insulin alone Vs Insulin plus Metformin

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036889

Enrollment

Registered

2021-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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: Insulin: Initial Insulin administration will depend on the pattern of hyperglycemia. As potent steroids (prednisolone and dexamethasone) are given in divided doses as per institutiona

Eligibility

Inclusion criteria

Inclusion criteria: All children ( <18 years) with Acute Lymphoblastic leukemia (ALL) treated under the Division of Paediatric Hematology and Oncology, Manipal Comprehensive Cancer Care Centre, Kasturba Medical College, Manipal.

Exclusion criteria

Exclusion criteria: 1.Children with ALL developing Diabetic Ketoacidosis (DKA) 2.Children with underlying Diabetes Mellitus/Impaired Glucose Tolerance/kidney or liver failure 4. Children with acute/chronic pancreatitis. 5. Children on drugs which interact with metformin. 6.Those children /parents refusing consent.

Design outcomes

Primary

Measure	Time frame
The median days to achieve euglycemia after the initiation of Drug induced Diabetes Mellitus directed treatment.Timepoint: Up to 35 days after randomization	—

Secondary

Measure	Time frame
1. Compare treatment charges incurred during induction phase of chemotherapy between the treatment arms. 2.Incidence of febrile neutropenia episodes during the first 1-month of ALL therapy, 3.The proportion of patients developing fungal and other infections during the first 1-month of ALL therapy 4. The proportions of patients achieving complete remission (CR) with bone marrow minimal residual disease (MRD) negativity post-induction phase. 5. Incidence of early mortality ( 2 months from diagnosis)Timepoint: 1. Up to 35 days after randomization 2.Up to 35 days after randomization 3.Up to 35 days after randomization 4.Up to 35 days after randomizationUp to 35 days after randomization	—

Measure

Time frame

1. Compare treatment charges incurred during induction phase of chemotherapy between the treatment arms. 2.Incidence of febrile neutropenia episodes during the first 1-month of ALL therapy, 3.The proportion of patients developing fungal and other infections during the first 1-month of ALL therapy 4. The proportions of patients achieving complete remission (CR) with bone marrow minimal residual disease (MRD) negativity post-induction phase. 5. Incidence of early mortality ( 2 months from diagnosis)Timepoint: 1. Up to 35 days after randomization 2.Up to 35 days after randomization 3.Up to 35 days after randomization 4.Up to 35 days after randomizationUp to 35 days after randomization

—

Countries

India

Contacts

Public ContactKoushik H

Kasturba Medical College, Manipal

koushik.h@manipal.edu9242308804

Outcome results

None listed

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