An interventional study of Metformin in Acute Lymphoblastic Leukemia, Hyperglycemia and Insulin Resistance, sponsored by Children's Hospital Los Angeles. Terminated at 1 site in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2015-01-30.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Up to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia
Drug: Metformin
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.
Also known as: Glucophage, Metformin HCl
Length of Insulin Therapy (Days)
Time frame: During the 30 days of induction chemotherapy (plus or minus 2 weeks)
Serum Fructosamine Level
Time frame: At 1 month
Hemoglobin A1c
Time frame: At 1 month
| Milestone | Metformin and Insulin Therapy |
|---|---|
| Started | 4 |
| Completed | 2 |
| Not completed | 2 |
| days | Metformin and Insulin Therapy |
|---|---|
| Length of Insulin Therapy (Days) | 7.5 (0 to 15) |
| uM | Metformin and Insulin Therapy |
|---|---|
| Serum Fructosamine Level | 190 (182 to 198) |
| percent of hemoglobin | Metformin and Insulin Therapy |
|---|---|
| Hemoglobin A1c | 4.8 (4.3 to 5.3) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin and Insulin Therapy | — | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Metformin and Insulin Therapy |
|---|---|
| Mean | 13.5 (12 to 15) |
| Sex: Female, Male(Participants) | Metformin and Insulin Therapy |
|---|---|
| Female | 0 |
| Male | 2 |
| Region of Enrollment(participants) | Metformin and Insulin Therapy |
|---|---|
| United States | 2 |
| Hemoglobin A1C(%) | Metformin and Insulin Therapy |
|---|---|
| Mean | 5.8 (5.5 to 6) |
| Fructosamine(uM) | Metformin and Insulin Therapy |
|---|---|
| Mean | 193 (178 to 207) |
| # of Day of Induction at Onset of Hyperglycemia(days) | Metformin and Insulin Therapy |
|---|---|
| Mean | 2 (2 to 2) |
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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