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PROGENS-HbA 1c study: safety and effectiveness of premixed recombinant human insulin (Gensulin M30)

View Article: PubMed Central - PubMed

ABSTRACT

Introduction: 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.

Material and 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/m2 and 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.

No MeSH data available.


Study diagram
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Figure 0001: Study diagram

Mentions: After the first visit, there were two follow-up visits, scheduled every 3 months, so that the patients were observed over a total of 6 months. A flow chart is shown in Figure 1. The study was a multicenter one, conducted in 150 diabetological centers in Poland. The insulin dose was modified during the visits according to the HbA1c level (the target HbA1c level was determined individually for each patient). Insulin was administered through the GensuPen automatic injection system. Patients were advised to inject the insulin according to the drug description – 15 min before mealtime.


PROGENS-HbA 1c study: safety and effectiveness of premixed recombinant human insulin (Gensulin M30)
Study diagram
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5016585&req=5

Figure 0001: Study diagram
Mentions: After the first visit, there were two follow-up visits, scheduled every 3 months, so that the patients were observed over a total of 6 months. A flow chart is shown in Figure 1. The study was a multicenter one, conducted in 150 diabetological centers in Poland. The insulin dose was modified during the visits according to the HbA1c level (the target HbA1c level was determined individually for each patient). Insulin was administered through the GensuPen automatic injection system. Patients were advised to inject the insulin according to the drug description – 15 min before mealtime.

View Article: PubMed Central - PubMed

ABSTRACT

Introduction: 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.

Material and 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/m2 and 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.

No MeSH data available.