Metformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy
ALL is the most common childhood cancer, representing one fourth of all cancers diagnosed
under the age of 15 years. One of the most common side effects of ALL chemotherapy is
transient hyperglycemia. Patients that develop this complication require treatment with
insulin via injections to prevent severe medical complications such as dehydration, weight
loss, ketoacidosis and life-threatening infections. Although insulin therapy is effective,
it adds a lot of physical and psychological burden to patients because multiple daily
insulin injections are required to achieve adequate blood glucose control.
In this pilot study, investigators aim to examine the effectiveness of metformin as an
adjunctive treatment for transient hyperglycemia. Investigators will be comparing two
groups of subjects (up to 40 subjects per group). Patients in the treatment group will be
prospectively recruited, and they will be treated with metformin in addition to insulin
therapy. Investigators will compare the treatment group to a historical control group
acquired via chart review. These patients will have been treated with insulin alone.
Statistical comparison will be made between the two groups in terms of the length of insulin
treatment, the total daily dose of insulin required, number of insulin injections,
hemoglobin A1c level (measure of glycemic control over preceding 8- 12 weeks), and
fructosamine level (measure of glycemic control over preceding 2-3 weeks).
Investigators hypothesize that the use of metformin will result in fewer numbers of insulin
injections and fewer days of insulin therapy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Length of insulin therapy (days)
Total number of days of insulin therapy will vary among subjects with different degee of insulin resistance and insulin need. We will be monitoring lenghth of insulin therapy until subject is weaned off insulin, which typically occurs in 1-2 weeks after completion of induction chemotherapy.
During the 30 days of induction chemotherapy (plus or minus 2 weeks)
Jamie R Wood, M.D.
Children's Hospital Los Angeles
United States: Institutional Review Board
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