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

Abstract

IntroductionInsulin 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 methodsThe 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.ResultsThe 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.ConclusionsThis study shows rhuI Gensulin M30 to be effective and safe in a real-life setting.

Efficacy, Safety, and Quality of Treatment Satisfaction of Premixed Human and Analogue Insulin Regimens in a Large Cohort of Type 2 Diabetic Patients: PROGENS BENEFIT Observational Study

“…In fact, body mass was reduced significantly in both studied groups which may be explained simply by participation in the study and willingness to obtain better results. Maintaining, however, not reducing BMI is in accordance with other observational study performed among Polish cohort of patients treated with biphasic human insulin [ 26 ]. Besides insulin therapy, patients were given support related to behavioral treatment of the disease, which is of extreme importance since it was proven in another large cohort of Polish patients with type 2 diabetes that their diet-related knowledge is insufficient and their physical activities are very low [ 27 ].…”

Outcomes of transition from premixed and intensive insulin therapies to insulin aspart/degludec co-formulation in type 2 diabetes mellitus: a real-world experience

“…The frequency of hypoglycaemia in response to changing insulin therapy may vary significantly among patients [ 2 , 32 ]. Although it is recommended that the dose remain unchanged during the transition from premixed or intensive injection regimen to the IDegAsp, it is still advisable to determine the doses according to the patient’s specific needs in all switches.…”

Diagnostic Accuracy of Glycated Haemoglobin and Average Glucose Values in Type 2 Diabetes Mellitus Treated with Premixed Insulin

“…This study is a pre-specified analysis of the data from the PROGENS HbA1c study [ 20 ], a phase 4 observational study, in which 4257 subjects who started insulin treatment with premixed human insulin (Gensulin, Bioton, Poland) were observed for 6 months. The primary aim was to assess the effectiveness and safety of this drug, and the secondary aim was to compare the HbA1c value with the ABG value.…”