Clinical trial · Interventional
Metformin and Transient Hyperglycemia
Metformin as an Adjunctive Therapy For Transient Hyperglycemia in Patients With Acute Lymphoblastic Leukemia During Induction Chemotherapy
NCT01486043CI-TRIAL-00016735terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The research project was terminated due to lower than projected patient recruitment within the period of time allowed for the study.
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diabetes Mellitus | — | UNRESOLVED | — |
| Hyperglycemia | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin and insulin therapy
- 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
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Length of Insulin Therapy (Days)
- timeFrame
- During the 30 days of induction chemotherapy (plus or minus 2 weeks)
Secondary outcomes (2)
- measure
- Serum Fructosamine Level
- timeFrame
- At 1 month
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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%)
References
Publications (5)
- BACKGROUNDPui 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 6454771
- BACKGROUNDBaillargeon 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 15700246
- BACKGROUNDLowas 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 19260096
- BACKGROUNDHoward 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 12350366
- BACKGROUNDSonabend 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 19394046