Vol 4, No 4 (2003): Practical Diabetology
Research paper
Published online: 2003-09-18
An open multicentre trial to study the efficacy and safety of human insulin Gensulin in patients with type 1 and 2 diabetes mellitus — assumptions and preliminary results at 28 weeks
Diabetologia Praktyczna 2003;4(4):287-294.
Abstract
INTRODUCTION. Long-term multicentre prospective studies provided evidence
for the value of good diabetes control in the prevention of complications and
inhibition of their progression. Adequate diabetes control can be achieved with
human insulin synthesised by DNA recombination technique. Gensulin is the first
Polish recombinant human insulin.
AIM. 1. To evaluate the efficacy of Gensulin based upon the effect of treatment on diabetes control measured by 24 hr glycemia and HbA1c levels. 2. To evaluate the safety of Gensulin based upon the effect of treatment on the occurrence of hypoglycemia, cardiovascular function, liver and kidney function and insulin immunogenicity. 3. To evaluate the effect of Gensulin on the quality of life based upon a questionnaire.
MATERIAL AND METHODS. It is an open phase IV study designed to recruit 60 patients with DMT1 and DMT2 within 52 weeks. The present preliminary analysis was carried out in 25 patients — 13 with DMT1 and 12 with DMT2, who completed visit 8 i.e. had been receiving Gensulin for 28 weeks. Patients with DMT1 were receiving Gensulin R and N in 4–5 injections (IT), patients with DMT2 were given the IT model or 2 injections of Gensulin R and N.
RESULTS AND CONCLUSIONS. Within the first 28 weeks on Gensulin treatment there were no significant differences in diabetes control measured by HbA1c (visit 1 — 7.6 ± 0.7%/visit 8 — 7.5 ± 0.9% in DMT1 and 6.9 ± 0.8%/7.0 ± 0.8% in DMT2). In both groups daily variations in glycemia measured by standard deviation of the mean glycemia were significantly lower (DMT1: visit 1 — 46.3 ± 20.4 mg/dl/visit 7 — 34.4 ± 12.8 mg/dl and DMT2: visit 1 — 34.9 ± 14.2 mg/dl/visit 8 — 20.3 ± 6.6 mg/dl). In both types of diabetes glycemia control measured by J index was improved. The frequency of hypoglycemia corresponded to that during treatment with other insulin preparations (DMT1 — 1.19/personmonth, DMT2 — 0.13/personmonth). Gensulin has similar clinical properties to other human insulin preparations.
AIM. 1. To evaluate the efficacy of Gensulin based upon the effect of treatment on diabetes control measured by 24 hr glycemia and HbA1c levels. 2. To evaluate the safety of Gensulin based upon the effect of treatment on the occurrence of hypoglycemia, cardiovascular function, liver and kidney function and insulin immunogenicity. 3. To evaluate the effect of Gensulin on the quality of life based upon a questionnaire.
MATERIAL AND METHODS. It is an open phase IV study designed to recruit 60 patients with DMT1 and DMT2 within 52 weeks. The present preliminary analysis was carried out in 25 patients — 13 with DMT1 and 12 with DMT2, who completed visit 8 i.e. had been receiving Gensulin for 28 weeks. Patients with DMT1 were receiving Gensulin R and N in 4–5 injections (IT), patients with DMT2 were given the IT model or 2 injections of Gensulin R and N.
RESULTS AND CONCLUSIONS. Within the first 28 weeks on Gensulin treatment there were no significant differences in diabetes control measured by HbA1c (visit 1 — 7.6 ± 0.7%/visit 8 — 7.5 ± 0.9% in DMT1 and 6.9 ± 0.8%/7.0 ± 0.8% in DMT2). In both groups daily variations in glycemia measured by standard deviation of the mean glycemia were significantly lower (DMT1: visit 1 — 46.3 ± 20.4 mg/dl/visit 7 — 34.4 ± 12.8 mg/dl and DMT2: visit 1 — 34.9 ± 14.2 mg/dl/visit 8 — 20.3 ± 6.6 mg/dl). In both types of diabetes glycemia control measured by J index was improved. The frequency of hypoglycemia corresponded to that during treatment with other insulin preparations (DMT1 — 1.19/personmonth, DMT2 — 0.13/personmonth). Gensulin has similar clinical properties to other human insulin preparations.
Keywords: diabetesinsulin therapyGensulin