Vol 4, No 4 (2003): Practical Diabetology
Research paper
Published online: 2003-09-18
A randomized, crossover, controlled study evaluating efficiency and safety of a new biosynthetic human insulin preparation — Gensulin versus commercially available human insulin in patients with type 1 diabetes on intensified insulin therapy
Diabetologia Praktyczna 2003;4(4):279-286.
Abstract
INTRODUCTION. To compare the efficiency and safety of Gensulin with that
of the original human insulin preparation in patients with type 1 diabetes on
intensified insulin therapy, during short-term hospitalization.
MATERIAL AND METHODS. Prospective, one-centre, randomised, double-blind, crossover comparative trial, including 20 patients (17 men and 3 women), with type 1 diabetes and with good or not satisfactory metabolic control, all on multiply (4) daily doses of insulin, using soluble insulin before meals and isophane insulin at night. Following a 1–3 day runin period, each patient received 7-day treatment with Gensulin and 7-day treatment with commercially available insulin, in random order. The main outcome measures were: 8-point glucose profiles, insulin dose, frequency of hypoglycaemic episodes, amount of carbohydrates in patients’ diet and adverse events monitoring. Efficiency evaluation was based on such mathematics indicators of glycaemia control as mean daily blood glucose level (MBG), daily fluctuations of glycaemia (SD), and J index — (connecting both of them), and on the analysis of mean daily doses of insulin. Safety evaluation was established by the number of hypoglycaemia episodes and the number of adverse events and serious adverse events.
RESULTS. Study results were statistically analyzed. No statistically significant difference between diet in week I and II of the study was found. (P = 0.020324; P > 0.05). No statistically significant differences in safety index defined as registered hypoglycemic events of both insulin preparations were found (P > 0.05), however safety index defined as total hypoglycemic events number in the study for Gensulin and reference insulin preparations was statistically significantly different (P < 0.05). Better results were related to Gensulin. Bioton and reference insulin preparations treatment efficiency evaluation were performed based on effective dose and revealed no differences between the preparations.
MATERIAL AND METHODS. Prospective, one-centre, randomised, double-blind, crossover comparative trial, including 20 patients (17 men and 3 women), with type 1 diabetes and with good or not satisfactory metabolic control, all on multiply (4) daily doses of insulin, using soluble insulin before meals and isophane insulin at night. Following a 1–3 day runin period, each patient received 7-day treatment with Gensulin and 7-day treatment with commercially available insulin, in random order. The main outcome measures were: 8-point glucose profiles, insulin dose, frequency of hypoglycaemic episodes, amount of carbohydrates in patients’ diet and adverse events monitoring. Efficiency evaluation was based on such mathematics indicators of glycaemia control as mean daily blood glucose level (MBG), daily fluctuations of glycaemia (SD), and J index — (connecting both of them), and on the analysis of mean daily doses of insulin. Safety evaluation was established by the number of hypoglycaemia episodes and the number of adverse events and serious adverse events.
RESULTS. Study results were statistically analyzed. No statistically significant difference between diet in week I and II of the study was found. (P = 0.020324; P > 0.05). No statistically significant differences in safety index defined as registered hypoglycemic events of both insulin preparations were found (P > 0.05), however safety index defined as total hypoglycemic events number in the study for Gensulin and reference insulin preparations was statistically significantly different (P < 0.05). Better results were related to Gensulin. Bioton and reference insulin preparations treatment efficiency evaluation were performed based on effective dose and revealed no differences between the preparations.
Keywords: type 1 diabetesbiosynthetic human insulinefficiencysafety