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
目的:对比降糖药物控制不佳2型糖尿病(Type 2 diabetes mellitus,T2DM)患者应用德谷门冬双胰岛素(Insulin degludec/aspart,IDegAsp)与门冬胰岛素30治疗的临床效果。方法:76例服用降糖药物控制不佳T2DM患者,随机分为对照组(n=36)和观察...目的:对比降糖药物控制不佳2型糖尿病(Type 2 diabetes mellitus,T2DM)患者应用德谷门冬双胰岛素(Insulin degludec/aspart,IDegAsp)与门冬胰岛素30治疗的临床效果。方法:76例服用降糖药物控制不佳T2DM患者,随机分为对照组(n=36)和观察组(n=36),两组均给予二甲双胍(Metformin,MET)基础治疗,在此基础上,对照组给予门冬胰岛素30治疗,观察组给予IDegAsp治疗,连续治疗3m,对比两组胰岛素类似物用量、血糖达标时间、糖代谢指标及胰岛功能指标,并记录不良反应发生情况。结果:两组胰岛素类似物用量对比无明显差异;观察组血糖达标时间较对照组更短(P<0.05);治疗3 m后,两组上述糖代谢指标均下降,且观察组低于对照组(P<0.05);治疗3m后,两组血清胰岛素(Insulin,FIns)、胰岛β细胞功能(Homeostasis Model Assessment of beta-cellfunction,HOMA-β)升高,胰岛素抵抗指数(Homeostasis Model Assessment of Insulin Resistance,HOMA-IR)下降,且观察组优于对照组(P<0.05);两组患者不良反应发生率比较差异无统计学意义。结论:相较于门冬胰岛素30,IDegAsp用于降糖药物控制不佳T2DM患者,降糖效果突出,能有效改善患者胰岛功能,且安全性良好。展开更多
目的:探究门冬胰岛素30联合格列喹酮对2型糖尿病(T2DM)患者糖脂代谢指标的影响。方法:选取2021年5月—2022年5月平和县医院收治的80例T2DM患者,按随机数表法分为两组,各40例。对照组采用门冬胰岛素30治疗,观察组在此基础上加用格列喹酮...目的:探究门冬胰岛素30联合格列喹酮对2型糖尿病(T2DM)患者糖脂代谢指标的影响。方法:选取2021年5月—2022年5月平和县医院收治的80例T2DM患者,按随机数表法分为两组,各40例。对照组采用门冬胰岛素30治疗,观察组在此基础上加用格列喹酮治疗。比较两组治疗前、治疗12周后的糖脂代谢指标[空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、总胆固醇(TC)]、胰岛素抵抗指数(HOMA-IR)及不良反应发生率。结果:治疗12周后,两组FBG、2 h PG、HbA1c、TC及HOMA-IR均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:门冬胰岛素30联合格列喹酮可改善T2DM患者的糖脂代谢水平,降低其HOMA-IR,且不增加不良反应。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,
文摘目的:对比降糖药物控制不佳2型糖尿病(Type 2 diabetes mellitus,T2DM)患者应用德谷门冬双胰岛素(Insulin degludec/aspart,IDegAsp)与门冬胰岛素30治疗的临床效果。方法:76例服用降糖药物控制不佳T2DM患者,随机分为对照组(n=36)和观察组(n=36),两组均给予二甲双胍(Metformin,MET)基础治疗,在此基础上,对照组给予门冬胰岛素30治疗,观察组给予IDegAsp治疗,连续治疗3m,对比两组胰岛素类似物用量、血糖达标时间、糖代谢指标及胰岛功能指标,并记录不良反应发生情况。结果:两组胰岛素类似物用量对比无明显差异;观察组血糖达标时间较对照组更短(P<0.05);治疗3 m后,两组上述糖代谢指标均下降,且观察组低于对照组(P<0.05);治疗3m后,两组血清胰岛素(Insulin,FIns)、胰岛β细胞功能(Homeostasis Model Assessment of beta-cellfunction,HOMA-β)升高,胰岛素抵抗指数(Homeostasis Model Assessment of Insulin Resistance,HOMA-IR)下降,且观察组优于对照组(P<0.05);两组患者不良反应发生率比较差异无统计学意义。结论:相较于门冬胰岛素30,IDegAsp用于降糖药物控制不佳T2DM患者,降糖效果突出,能有效改善患者胰岛功能,且安全性良好。
文摘目的:探究门冬胰岛素30联合格列喹酮对2型糖尿病(T2DM)患者糖脂代谢指标的影响。方法:选取2021年5月—2022年5月平和县医院收治的80例T2DM患者,按随机数表法分为两组,各40例。对照组采用门冬胰岛素30治疗,观察组在此基础上加用格列喹酮治疗。比较两组治疗前、治疗12周后的糖脂代谢指标[空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、总胆固醇(TC)]、胰岛素抵抗指数(HOMA-IR)及不良反应发生率。结果:治疗12周后,两组FBG、2 h PG、HbA1c、TC及HOMA-IR均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:门冬胰岛素30联合格列喹酮可改善T2DM患者的糖脂代谢水平,降低其HOMA-IR,且不增加不良反应。
