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Metformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy

10 Years
21 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia, Hyperglycemia, Insulin Resistance, Diabetes Mellitus

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Trial Information

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.

Inclusion Criteria:

- ALL patients on induction chemotherapy who develop transient hyperglycemia(definition
of transient hyperglycemia: random blood glucose > 200 mg/dL x 2)

- Adequate renal function (serum Cr < 1.5 mg/dL in males, < 1.2 mg/dL in females)

- Adequate hepatic function (AST and ALT < 2.5x upper limit of normal)

Exclusion Criteria:

- Patients with known diagnosis of diabetes or those that are already on oral
hypoglycemic agents or insulin

- Allergy to metformin or any component of the formulation

- Patients with pancreatitis (lipase level > 300 Units/L)

- Patients with active infection (positive blood culture within 48 hours of study

- Patients with hemodynamic instability (PICU status, need for vasopressors within 48
hours of study entry)

- Elevated hemoglobin A1c (greater than 6.0%)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Length of insulin therapy (days)

Outcome Description:

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.

Outcome Time Frame:

During the 30 days of induction chemotherapy (plus or minus 2 weeks)

Safety Issue:


Principal Investigator

Jamie R Wood, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Los Angeles


United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

June 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Hyperglycemia
  • Insulin Resistance
  • Diabetes Mellitus
  • Induction chemotherapy
  • Transient hyperglycemia
  • Metformin
  • Acute lymphoblastic leukemia
  • Insulin resistance
  • Hyperglycemia
  • Insulin
  • Diabetes Mellitus
  • Hyperglycemia
  • Insulin Resistance
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Children's Hospital Los AngelesLos Angeles, California  90027-0700