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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.


Related in: MedlinePlus

Comparison of frequency of hypoglycemic episodes in patients on stable insulin dose (P) and in those in whom the dose was decreased (D) or increased (I)*p < 0.05, *p < 0.001 (D vs. P), ##p < 0.001 (I vs. P).
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Figure 0004: Comparison of frequency of hypoglycemic episodes in patients on stable insulin dose (P) and in those in whom the dose was decreased (D) or increased (I)*p < 0.05, *p < 0.001 (D vs. P), ##p < 0.001 (I vs. P).

Mentions: During the study no SAE were recorded other than severe hypoglycemia. However, as in many cases the CRFs did not allow for reliable differentiation between particular types of hypoglycemia, this part of the analysis was conducted on 3465 patients only. The frequency of hypoglycemia increased slightly during the study with the intensification of treatment, although it remained low even then (11.6% documented episodes and 0.4% severe episodes at visit 3; accurate percentage data of hypoglycemic episodes during the study are presented in Figure 3), especially with regard to severe hypoglycemic episodes. The lowest number of hypoglycemic episodes occurred in patients treated with metformin, while the highest number was recorded in patients treated with insulin alone. Overall, the number of severe episodes was low in all treatment groups (Table I), with an average of 0.02 episodes/patient/year. Episodes of hypoglycemia were more frequent in patients in whom doses of insulin were changed during the study, regardless of whether the dose was increased or decreased (Figure 4).


PROGENS-HbA 1c study: safety and effectiveness of premixed recombinant human insulin (Gensulin M30)
Comparison of frequency of hypoglycemic episodes in patients on stable insulin dose (P) and in those in whom the dose was decreased (D) or increased (I)*p < 0.05, *p < 0.001 (D vs. P), ##p < 0.001 (I vs. P).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0004: Comparison of frequency of hypoglycemic episodes in patients on stable insulin dose (P) and in those in whom the dose was decreased (D) or increased (I)*p < 0.05, *p < 0.001 (D vs. P), ##p < 0.001 (I vs. P).
Mentions: During the study no SAE were recorded other than severe hypoglycemia. However, as in many cases the CRFs did not allow for reliable differentiation between particular types of hypoglycemia, this part of the analysis was conducted on 3465 patients only. The frequency of hypoglycemia increased slightly during the study with the intensification of treatment, although it remained low even then (11.6% documented episodes and 0.4% severe episodes at visit 3; accurate percentage data of hypoglycemic episodes during the study are presented in Figure 3), especially with regard to severe hypoglycemic episodes. The lowest number of hypoglycemic episodes occurred in patients treated with metformin, while the highest number was recorded in patients treated with insulin alone. Overall, the number of severe episodes was low in all treatment groups (Table I), with an average of 0.02 episodes/patient/year. Episodes of hypoglycemia were more frequent in patients in whom doses of insulin were changed during the study, regardless of whether the dose was increased or decreased (Figure 4).

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 &plusmn;9.4, with body mass index (BMI) 30.3 &plusmn;4.5 kg/m2 and diabetes duration 9 &plusmn;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 &plusmn;18.7 U (0.42 &plusmn;0.22 U/kg), and by the end of the study it reached 40.3 &plusmn;18.9 U (0.48 &plusmn;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.


Related in: MedlinePlus