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Glucose Control In Severely Burned Patients Using Metformin- An Interim Safety And Efficacy Analysis Of A Phase Ii Rct
Marc G Jeschke, Marjorie Burnett*, Abdikarim Abdullahi*, Sarah Rehou*, Mile Stanojocic*
University of Toronto, Toronto, ON, Canada

Objective: Insulin administration improves clinical outcomes after burn, but also causes a 4-5 fold increase in hypoglycemia, which is associated with a 9-fold increase in mortality. We hypothesized that metformin can achieve glucose control no worse than insulin (non-inferiority) without the danger of hypoglycemia (superiority), plus has effects on lipolysis and inflammation that will enhance burn recovery (superiority).
Methods: Burned adult patients with burns over 20% TBSA burn were prospectively randomized in this Phase II clinical trial to either metformin or insulin (standard of care) treatment. Primary outcome was glucose levels and incidence of hypoglycemia. Secondary outcomes included glucose and fat metabolism, and clinical outcomes.
Results: Thirty-one patients were enrolled in this trial, 14 metformin and 17 insulin patients. Demographics, injury characteristics, and mortality were comparable between both groups. Metformin controlled blood glucose as equally as insulin with no difference between the two treatment groups, P>0.05. While there was a 16% incidence of hypoglycemia in the insulin group, there was only one hypoglycemic episode (2%) in the metformin group, P<0.05. Oral glucose tolerance tests at discharge revealed that metformin significantly improved insulin sensitivity, P<0.05. Metformin furthermore had a strong anti-inflammatory and anti-lipolytic effect after burn injury when compared to insulin, P<0.05 associated with significantly reduced hypermetabolism, P<0.05.
Conclusions: Metformin decreases glucose as equally effective as insulin without causing hypoglycemia, while metformin further improves insulin resistance when compared to insulin. These results strongly support the use of metformin in severely burned patients for post-burn control of hyperglycemia and insulin resistance.


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