open access

Vol 4, No 4 (2003): Practical Diabetology
Original articles (submitted)
Published online: 2003-09-18
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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

Elżbieta Kozek, Władysław Grzeszczak, Janusz Gumprecht, Bogna Wierusz-Wysocka, Judyta Schlaffke, Magdalena Trepińska, Teresa Koblik, Katarzyna Cyganek, Barbara Katra, Jacek Sieradzki, Monika Bogiel
Diabetologia Praktyczna 2003;4(4):287-294.

open access

Vol 4, No 4 (2003): Practical Diabetology
Original articles (submitted)
Published online: 2003-09-18

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.

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.
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Keywords

diabetes; insulin therapy; Gensulin

About this article
Title

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

Journal

Clinical Diabetology

Issue

Vol 4, No 4 (2003): Practical Diabetology

Pages

287-294

Published online

2003-09-18

Bibliographic record

Diabetologia Praktyczna 2003;4(4):287-294.

Keywords

diabetes
insulin therapy
Gensulin

Authors

Elżbieta Kozek
Władysław Grzeszczak
Janusz Gumprecht
Bogna Wierusz-Wysocka
Judyta Schlaffke
Magdalena Trepińska
Teresa Koblik
Katarzyna Cyganek
Barbara Katra
Jacek Sieradzki
Monika Bogiel

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