PROGENS-HbA1cstudy: safety and effectiveness of premixed recombinant human insulin (Gensulin M30).
BACKGROUND
Insulin analogues have gained widespread popularity. However, in many countries the use of these drugs is limited by their relatively high cost, so there is still a need for more cost-effective human insulin therapies. The aim of the study was to assess the effectiveness and safety of the premixed recombinant human insulin (rhuI) Gensulin M30 in a real-life setting.


METHODS
The study group consisted of 4257 patients (2196 female, 2061 male) with type 2 diabetes, aged 63.7 ±9.4, with body mass index (BMI) 30.3 ±4.5 kg/m2and diabetes duration 9 ±5.5 years. All patients were treated with premixed rhuI Gensulin M30. In 91.7% of patients, insulin was used in combination with metformin. In 3.7% of patients, it was used with sulphonylureas. The patients were observed for a period of 6 months.


RESULTS
The total insulin dose on visit 1 was 36.1 ±18.7 U (0.42 ±0.22 U/kg), and by the end of the study it reached 40.3 ±18.9 U (0.48 ±0.22 U/kg). A significant, continuous decrease of the levels of glycated hemoglobin (HbA1c), along with fasting and postprandial plasma glucose, was observed during the study period. The frequency of hypoglycemia increased slightly during the study, although these figures remained low, especially with regard to severe hypoglycemic episodes (0.02 episodes/patient/year). The lowest number of hypoglycemic episodes occurred in patients treated with insulin and metformin, while the highest number of episodes was observed in patients treated with insulin alone. No weight changes were noted in the patients during the study.


CONCLUSIONS
This study shows rhuI Gensulin M30 to be effective and safe in a real-life setting.
Department of Internal Diseases, Endocrinology and Diabetology, MSW Central Clinical Hospital, Warsaw, Poland.
Magdalena
M
Walicka
Department of Public Health, Czestochowa University of Technology, Czestochowa, Poland; Silesian Analytical Laboratories, Katowice, Poland.
Jacek
J
Jóźwiak
Clinical Department of Internal Diseases and Diabetology, 10th Military Hospital, Bydgoszcz, Poland.
Jacek
J
Rzeszotarski
Diabetology and Endocrinology Centre, Bydgoszcz, Poland.
Grażyna
G
Zarzycka-Lindner
ZA Medical Institute, Higher School of Computer Science and Business Administration, Lomza, Poland.
Anna
A
Zonenberg
PB Private Practice, Warsaw, Poland.
Paweł
P
Bijoś
Bioton SA, Warsaw, Poland.
Małgorzata
M
Masierek
Department of Internal Diseases, Endocrinology and Diabetology, MSW Central Clinical Hospital, Warsaw, Poland; Department of Human Epigenetics, Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
Edward
E
Franek
glycated hemoglobin; hypoglycemic episodes; type 2 diabetes
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