Metformin and Transient Hyperglycemia

Children's Hospital Los Angeles

Status: Terminated

Conditions: Hyperglycemia; Diabetes Mellitus; Insulin Resistance; Acute Lymphoblastic Leukemia

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01486043

CCI-11-00295

Details and patient eligibility

About

The purpose of this study is to determine whether metformin is an effective adjunctive treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL) undergoing induction chemotherapy

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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 < 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 registration)
• Patients with hemodynamic instability (PICU status, need for vasopressors within 48 hours of study entry)
• Elevated hemoglobin A1c (greater than 6.0%)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Metformin and insulin therapy

Experimental group

Description:

Up to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia

Treatment:

Drug: Metformin