Metformin and Transient Hyperglycemia
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
Acute Lymphoblastic Leukemia
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy|
- Length of insulin therapy (days) [ Time Frame: During the 30 days of induction chemotherapy (plus or minus 2 weeks) ] [ Designated as safety issue: No ]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.
- Total daily dose of insulin (unit of insulin per kilogram of subject's weight [ Time Frame: During the 30 days of induction chemotherapy (plus or minus 2 weeks) ] [ Designated as safety issue: No ]
- Number of insulin injections per day [ Time Frame: During the 30 days of induction chemotherapy (plus or minus 2 weeks) ] [ Designated as safety issue: No ]
- Serum fructosamine level [ Time Frame: On day 1 of study (prior to initiation of insulin and metformin therapy) and at 1 month ] [ Designated as safety issue: No ]
- Length of hospital stay (days) [ Time Frame: During the first 30 days of induction chemotherapy ] [ Designated as safety issue: No ]
- Hemoglobin A1c [ Time Frame: On day 1 of study (prior to initiation of insulin and metformin therapy) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Metformin and insulin therapy
Up to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia
All subjects will be started on metformin 500 mg orally twice daily. The dose will be increased by 500 mg weekly as tolerated until subjects' blood glucoses are well controlled or until the patient reaches metformin 1000 mg PO BID.
Other Name: Glucophage, Metformin HCl
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486043
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Principal Investigator:||Jamie R Wood, M.D.||Children's Hospital Los Angeles|