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Metformin as an Adjunct Therapy in Adolescents With Type 1 Diabetes and Insulin Resistance

A randomized controlled trial

¹ Division of Endocrinology, Hospital for Sick Children, Toronto, Ontario
² Department of Pediatrics, Izaak Walton Killam Health Centre, Halifax, Nova Scotia, Canada
³ School of Kinesiology, Simon Fraser University, Burnaby, British Columbia, Canada

OBJECTIVE—To evaluate whether, in adolescents with type 1 diabetes, the addition of metformin to insulin and standard diabetes management results in 1) higher insulin sensitivity and 2) lower HbA_1c, fasting glucose, insulin dosage (units per kilogram per day) and BMI.

RESEARCH DESIGN AND METHODS—This was a randomized, placebo-controlled 3-month trial of metformin therapy in 27 adolescents with type 1 diabetes, high insulin dosage (>1 unit · kg^-1 · day^-1), and HbA_1c >8%, with measurements of insulin sensitivity (by frequently sampled intravenous glucose tolerance test [FSIGT]), HbA_1c, insulin dosage, and BMI at the onset and end of treatment.

RESULTS—At t = 0, HbA_1c was 9.2 ± 0.9%, insulin dosage was 1.2 ± 0.2 units · kg^-1 · day^-1, fasting glucose was 10.6 ± 2.4 mmol/l, and BMI was 24.2 ± 3.9 kg/m² (means ± SD), with no difference between the metformin and placebo groups. At the end of the study, HbA_1c was 0.6% lower in the metformin group than in the placebo group (P < 0.05). This was achieved at lower daily insulin dosages (metformin group –0.14 ± 0.1 vs. placebo group 0.02 ± 0.2 units · kg^-1 · day^-1; P < 0.05), with no significant change in BMI. Fasting glucose levels improved significantly in the metformin group (P < 0.05). Change in insulin sensitivity, measured by FSIGT, was not significantly different between the two groups at study end. Mild hypoglycemia occurred more frequently in the metformin-treated than in the placebo subjects (1.75 ± 0.8 vs. 0.9 ± 0.4 events · patient^-1 · week^-1; P = 0.03). There were no differences in frequency of severe hypoglycemic episodes or gastrointestinal complaints between the two groups.

CONCLUSIONS—Metformin treatment lowered HbA_1c and decreased insulin dosage with no weight gain in teens with type 1 diabetes in poor metabolic control. Changes in insulin sensitivity were not documented in this study using the FSIGT. Long-term studies will determine whether these improvements are sustained and whether certain subgroups accrue greater benefit from this therapy.

Abbreviations: DCCT, Diabetes Control and Complications Trial • FSIGT, frequently sampled intravenous glucose tolerance test • GH, growth hormone • GHBP, GH binding protein • MINMOD, minimal model • S_I, insulin sensitivity.

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