Study Stopped
The research project was terminated due to lower than projected patient recruitment within the period of time allowed for the study.
Metformin and Transient Hyperglycemia
Metformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy
1 other identifier
interventional
4
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
January 30, 2015
CompletedJanuary 30, 2015
January 1, 2015
1.4 years
November 30, 2011
January 13, 2015
January 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Insulin Therapy (Days)
During the 30 days of induction chemotherapy (plus or minus 2 weeks)
Secondary Outcomes (2)
Serum Fructosamine Level
At 1 month
Hemoglobin A1c
At 1 month
Study Arms (1)
Metformin and insulin therapy
EXPERIMENTALUp to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Related Publications (5)
Pui CH, Burghen GA, Bowman WP, Aur RJ. Risk factors for hyperglycemia in children with leukemia receiving L-asparaginase and prednisone. J Pediatr. 1981 Jul;99(1):46-50. doi: 10.1016/s0022-3476(81)80955-9.
PMID: 6454771BACKGROUNDBaillargeon J, Langevin AM, Mullins J, Ferry RJ Jr, DeAngulo G, Thomas PJ, Estrada J, Pitney A, Pollock BH. Transient hyperglycemia in Hispanic children with acute lymphoblastic leukemia. Pediatr Blood Cancer. 2005 Dec;45(7):960-3. doi: 10.1002/pbc.20320.
PMID: 15700246BACKGROUNDLowas SR, Marks D, Malempati S. Prevalence of transient hyperglycemia during induction chemotherapy for pediatric acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 Jul;52(7):814-8. doi: 10.1002/pbc.21980.
PMID: 19260096BACKGROUNDHoward SC, Pui CH. Endocrine complications in pediatric patients with acute lymphoblastic leukemia. Blood Rev. 2002 Dec;16(4):225-43. doi: 10.1016/s0268-960x(02)00042-5.
PMID: 12350366BACKGROUNDSonabend RY, McKay SV, Okcu MF, Yan J, Haymond MW, Margolin JF. Hyperglycemia during induction therapy is associated with poorer survival in children with acute lymphocytic leukemia. J Pediatr. 2009 Jul;155(1):73-8. doi: 10.1016/j.jpeds.2009.01.072. Epub 2009 Apr 25.
PMID: 19394046BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Dr. Jamie Wood
- Organization
- Children's Hospital Los Angeles
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie R Wood, M.D.
Children's Hospital Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Pediatrics; Director of Clinical Diabetes Programs at Children's Hospital Los Angeles, University of Southern California, Keck School of Medicine
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 6, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
January 30, 2015
Results First Posted
January 30, 2015
Record last verified: 2015-01