Objective: To analyse the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in a Jordanian subgroup of the 24-week, non-interventional A1chieve study. Methods: A total of 509 Jordanian patients with ty...Objective: To analyse the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in a Jordanian subgroup of the 24-week, non-interventional A1chieve study. Methods: A total of 509 Jordanian patients with type 2 diabetes (392 insulin-naive and 117 insulin-experienced) starting BIAsp30, alone or in combination with oral glucose-lowering drugs, were included. Safety and effectiveness outcomes were analysed over 24 weeks. Results: Patients had a mean age of 55.8 years, body mass index of 28.8 kg/m2 and diabetes duration of 9.4 years at baseline. Two serious adverse drug reactions of hypoglycaemia were reported. The proportion of patients who reported major hypoglycaemic events decreased (2.4% at baseline vs. 0.2% at Week 24, p = 0.0039). The proportion of patients reporting overall hypoglycaemia increased marginally (6.3% at baseline vs. 9.9% at Week 24, p = 0.0378), primarily attributed to a rise in minor and nocturnal hypoglycaemia reported in insulin-naive patients. From baseline to Week 24, the mean ± SD glycated haemoglobin A1c level decreased from 9.8% ± 1.4% to 7.4% ± 0.9% (p < 0.001). Significant reductions after 24 weeks were also noted in the mean fasting plasma glucose, postprandial plasma glucose, lipids, systolic blood pressure and quality of life (all p < 0.001), while the mean body weight increased by 1.8 ± 6.5 kg (p < 0.001). Conclusion: Overall, BIAsp 30 therapy was well-tolerated and resulted in improved glycaemic control in this Jordanian subgroup over 24 weeks.展开更多
Background The effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials,while results from cl...Background The effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials,while results from clinical practice remain limited.This subgroup analysis was to provide such findings from a large-scale non-interventional study.Methods A1chieve was a multinational,prospective,open-label,non-interventional,24-week study in patients with type 2 diabetes initiating insulin analogues in 28 countries across Asia,Africa,Europe,and Latin America.After physician had taken the decision to use this insulin,any patient with type 2 diabetes who was not treated with or who had started the study insulin within 4 weeks before inclusion was eligible.Patients were treated with study insulin alone or in combination with oral glucose-lowering drugs.Data on adverse drug reactions,hypoglycemia and glycemic control were collected at baseline,week 12 and 24.This is a report of a Chinese subgroup analysis from the A1chieve study.Results Totally,4 100 patients constituted this subgroup.No serious adverse drug reactions were reported.Rates of total,major,nocturnal hypoglycemic events （events/patient per year） were 1.47,0.10,0.31 at baseline and 1.35,0.00,0.22 at week 24,respectively.Glycemic control was improved as measured by hemoglobin A1c （mean 9.3％ to 7.0％,reduction -2.3％）,fasting plasma glucose （mean 10.2 to 6.8 mmol/L,reduction-3.5 mmol/L） and postprandial plasma glucose （mean 14.4 to 8.8 mmol/L,reduction-5.6 mmol/L）,all P ＜0.001.Change in mean body weight was ＋0.3 kg （P ＜0.001）.Conclusion In this subgroup analysis of the A1chieve study,biphasic insulin aspart 30 improved glycemic control with low risk of hypoglycemia.展开更多
In subjects with type 2 diabetes inadequately controlled with oral antidiabetic agents （OADs）, insulin therapy is usually started to improve glycaemic control after failure of diet, exercise and OADs.1 Although ther...In subjects with type 2 diabetes inadequately controlled with oral antidiabetic agents （OADs）, insulin therapy is usually started to improve glycaemic control after failure of diet, exercise and OADs.1 Although there is no standard way to introduce insulin treatment, premixed formulations are a popular option. They offer an alternative to basal-bolus therapy and provide basal and prandial coverage with a single injection. Indeed, Koivisto et al2 in 1999 reported that 39% of patients with type 2 diabetes worldwide used premixed insulin as part of their therapeutic regimen, The modern premixed insulins, such as biphasic insulin aspart 30 （BIAsp 30） are most frequently prescribed twice-daily （BID） in clinical practice. However,展开更多
Dear Dr. Martin Hovland, We learned from the literature that premixed insulins are short-acting insulin or rapid-acting insulin analogue mixed with intermediate-acting insulin in a fixed ratio, addressing FBG and PPBG...Dear Dr. Martin Hovland, We learned from the literature that premixed insulins are short-acting insulin or rapid-acting insulin analogue mixed with intermediate-acting insulin in a fixed ratio, addressing FBG and PPBG in one injection. There are two categories;high-mix and low-mix premixed insulins. We, a Saudi task force, gathered to develop an explicit, evidence-based consensus for the use of the low-mix premixed insulin for better glycemic control. The treatment with premixed aspart 30 was non-inferior to treatment with premixed insulin lispro 25. In addition, Self-monitored blood glucose levels were comparable. Safety profiles were similar between both treatments, as was the incidence of hypoglycemic episodes. The switch between both products of the low-mix family can be carried out without any problem. Both products of the low-mix premixed insulin analogues aspart 30/70 and premixed insulin lispro 25/75 have comparable efficacy and safety as shown from the medical literature. Therefore, we can change from one to another safely as demonstrated by the US FDA statement. In addition, the ergonomic features of KwikPen’s design and function may offer important advantages for the user during insulin administration.展开更多
文摘Objective: To analyse the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in a Jordanian subgroup of the 24-week, non-interventional A1chieve study. Methods: A total of 509 Jordanian patients with type 2 diabetes (392 insulin-naive and 117 insulin-experienced) starting BIAsp30, alone or in combination with oral glucose-lowering drugs, were included. Safety and effectiveness outcomes were analysed over 24 weeks. Results: Patients had a mean age of 55.8 years, body mass index of 28.8 kg/m2 and diabetes duration of 9.4 years at baseline. Two serious adverse drug reactions of hypoglycaemia were reported. The proportion of patients who reported major hypoglycaemic events decreased (2.4% at baseline vs. 0.2% at Week 24, p = 0.0039). The proportion of patients reporting overall hypoglycaemia increased marginally (6.3% at baseline vs. 9.9% at Week 24, p = 0.0378), primarily attributed to a rise in minor and nocturnal hypoglycaemia reported in insulin-naive patients. From baseline to Week 24, the mean ± SD glycated haemoglobin A1c level decreased from 9.8% ± 1.4% to 7.4% ± 0.9% (p < 0.001). Significant reductions after 24 weeks were also noted in the mean fasting plasma glucose, postprandial plasma glucose, lipids, systolic blood pressure and quality of life (all p < 0.001), while the mean body weight increased by 1.8 ± 6.5 kg (p < 0.001). Conclusion: Overall, BIAsp 30 therapy was well-tolerated and resulted in improved glycaemic control in this Jordanian subgroup over 24 weeks.
文摘Background The effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials,while results from clinical practice remain limited.This subgroup analysis was to provide such findings from a large-scale non-interventional study.Methods A1chieve was a multinational,prospective,open-label,non-interventional,24-week study in patients with type 2 diabetes initiating insulin analogues in 28 countries across Asia,Africa,Europe,and Latin America.After physician had taken the decision to use this insulin,any patient with type 2 diabetes who was not treated with or who had started the study insulin within 4 weeks before inclusion was eligible.Patients were treated with study insulin alone or in combination with oral glucose-lowering drugs.Data on adverse drug reactions,hypoglycemia and glycemic control were collected at baseline,week 12 and 24.This is a report of a Chinese subgroup analysis from the A1chieve study.Results Totally,4 100 patients constituted this subgroup.No serious adverse drug reactions were reported.Rates of total,major,nocturnal hypoglycemic events （events/patient per year） were 1.47,0.10,0.31 at baseline and 1.35,0.00,0.22 at week 24,respectively.Glycemic control was improved as measured by hemoglobin A1c （mean 9.3％ to 7.0％,reduction -2.3％）,fasting plasma glucose （mean 10.2 to 6.8 mmol/L,reduction-3.5 mmol/L） and postprandial plasma glucose （mean 14.4 to 8.8 mmol/L,reduction-5.6 mmol/L）,all P ＜0.001.Change in mean body weight was ＋0.3 kg （P ＜0.001）.Conclusion In this subgroup analysis of the A1chieve study,biphasic insulin aspart 30 improved glycemic control with low risk of hypoglycemia.
文摘In subjects with type 2 diabetes inadequately controlled with oral antidiabetic agents （OADs）, insulin therapy is usually started to improve glycaemic control after failure of diet, exercise and OADs.1 Although there is no standard way to introduce insulin treatment, premixed formulations are a popular option. They offer an alternative to basal-bolus therapy and provide basal and prandial coverage with a single injection. Indeed, Koivisto et al2 in 1999 reported that 39% of patients with type 2 diabetes worldwide used premixed insulin as part of their therapeutic regimen, The modern premixed insulins, such as biphasic insulin aspart 30 （BIAsp 30） are most frequently prescribed twice-daily （BID） in clinical practice. However,
文摘Dear Dr. Martin Hovland, We learned from the literature that premixed insulins are short-acting insulin or rapid-acting insulin analogue mixed with intermediate-acting insulin in a fixed ratio, addressing FBG and PPBG in one injection. There are two categories;high-mix and low-mix premixed insulins. We, a Saudi task force, gathered to develop an explicit, evidence-based consensus for the use of the low-mix premixed insulin for better glycemic control. The treatment with premixed aspart 30 was non-inferior to treatment with premixed insulin lispro 25. In addition, Self-monitored blood glucose levels were comparable. Safety profiles were similar between both treatments, as was the incidence of hypoglycemic episodes. The switch between both products of the low-mix family can be carried out without any problem. Both products of the low-mix premixed insulin analogues aspart 30/70 and premixed insulin lispro 25/75 have comparable efficacy and safety as shown from the medical literature. Therefore, we can change from one to another safely as demonstrated by the US FDA statement. In addition, the ergonomic features of KwikPen’s design and function may offer important advantages for the user during insulin administration.
