Objective: The purpose of this study was to determine the effect of adjuvant premeal pramlintide with postmeal insulin on postprandial hyperglycemia in children with type 1 diabetes mellitus (T1DM).
Methods: Eight adolescents with T1DM on intensive insulin therapy participated in an open-label, non-randomized, crossover study, comparing postprandial glucose excursions in study A (prescribed insulin regimen and given premeal) vs. study B (pramlintide + insulin). Prandial insulin dose for study B was decreased by 20% and given postmeal, while pramlintide was given just before the meal. Blood glucose (BG), glucagon, and pramlintide concentrations were measured basally and at timed intervals during a 300-min study period.
Results: Postprandial incremental BG for the duration of the study was reduced in study B vs. study A with AUC((-60 to 300 min)) (area under the curve) at 6600 +/- 2371 vs. 20 230 +/- 3126 mg/dL/min (367 +/- 132 vs. 1124 +/- 174 mmol/L/min) (p < 0.001). Glucagon concentration was suppressed for approximately 120 min following administration of 30 microg of pramlintide and postmeal insulin (p < 0.003). No severe hypoglycemic episodes were experienced in this study.
Conclusions: Postprandial hyperglycemia is considerably reduced in adolescents with T1DM when treated with fixed-dose premeal pramlintide, and precisely calculated postmeal insulin, without significant side effects.