Metformin and Transient Hyperglycemia

Overview[ - collapse ][ - ]

Purpose 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
ConditionAcute Lymphoblastic Leukemia
Hyperglycemia
Insulin Resistance
Diabetes Mellitus
InterventionDrug: Metformin
PhaseN/A
SponsorChildren's Hospital Los Angeles
Responsible PartyChildren's Hospital Los Angeles
ClinicalTrials.gov IdentifierNCT01486043
First ReceivedNovember 30, 2011
Last UpdatedDecember 2, 2011
Last verifiedDecember 2011

Tracking Information[ + expand ][ + ]

First Received DateNovember 30, 2011
Last Updated DateDecember 2, 2011
Start DateDecember 2011
Estimated Primary Completion DateJune 2013
Current Primary Outcome MeasuresLength 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.
Current Secondary Outcome Measures
  • 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]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin and Transient Hyperglycemia
Official TitleMetformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy
Brief Summary
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
Detailed 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.
Study TypeInterventional
Study PhaseN/A
Study DesignEndpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Acute Lymphoblastic Leukemia
  • Hyperglycemia
  • Insulin Resistance
  • Diabetes Mellitus
InterventionDrug: 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.
Other Names:
Glucophage, Metformin HCl
Study Arm (s)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

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment40
Estimated Completion DateJune 2013
Estimated Primary Completion DateJune 2013
Eligibility Criteria
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
registration)

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

- Elevated hemoglobin A1c (greater than 6.0%)
GenderBoth
Ages10 Years
Accepts Healthy VolunteersNo
ContactsContact: Jamie R Wood, M.D.
323-361-7388
jawood@chla.usc.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01486043
Other Study ID NumbersCCI-11-00295
Has Data Monitoring CommitteeYes
Information Provided ByChildren's Hospital Los Angeles
Study SponsorChildren's Hospital Los Angeles
CollaboratorsNot Provided
Investigators Principal Investigator: Jamie R Wood, M.D. Children's Hospital Los Angeles
Verification DateDecember 2011

Locations[ + expand ][ + ]

Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Principal Investigator: Jamie R. Wood, M.D.
Recruiting