BACKGROUND Gestational diabetes mellitus(GDM)refers to hyperglycemia caused by insulin resistance or insufficient insulin secretion during pregnancy.Patients with GDM have a high risk of pregnancy complications,which ...BACKGROUND Gestational diabetes mellitus(GDM)refers to hyperglycemia caused by insulin resistance or insufficient insulin secretion during pregnancy.Patients with GDM have a high risk of pregnancy complications,which can adversely affect both maternal and fetal health.Therefore,early diagnosis,treatment and monitoring of GDM are essential.In recent years,a new treatment scheme represented by insulin aspart combined with metformin has received increasing attention.AIM To explore the effects of insulin aspart combined with metformin on patients with GDM and inflammatory markers.METHODS From April 2020 to September 2022,124 patients with GDM in Sanya Women and Children’s Hospital Managed by Shanghai Children’s Medical Center were collected and analyzed retrospectively.The control group(CG)comprised 62 patients treated with insulin aspart alone,and 62 patients treated with insulin aspart and metformin formed the observation group(OG).Before and after treatment,improvement of blood-glucose-related indexes[fasting blood glucose(FBG),2-h postprandial glucose(2h PG)and hemoglobin A1c(HbA1c)],serum related factor[serum homocysteine(Hcy)],serum inflammatory cytokines[tumor necrosis factor(TNF)-α,interleukin(IL)-6 and C-reactive protein(CRP)]were compared between the two groups.The clinical efficacy,adverse pregnancy outcomes and incidence of pregnancy complications were compared between the two groups.RESULTS After treatment,the levels of FBG,2h PG,HbA1c,Hcy,TNF-α,IL-6 and CRP in both groups were significantly decreased(P<0.05),and the levels of FBG,2h PG,HbA1c,Hcy,TNF-α,IL-6 and CRP in the OG were lower than in the CG(P<0.05).The total clinical effectiveness in the OG was higher than that in the CG(P<0.05).The total incidence of adverse pregnancy outcomes and complications in the OG was significantly lower than in the CG(P<0.05).CONCLUSION Insulin aspart combined with metformin are effective for treatment of GDM,which can reduce blood-glucoserelated indexes,Hcy and serum inflammatory cytokines,and risk of adverse pregnancy outcomes and complications.展开更多
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 There is a lack of clinical evidence on the efficacy and safety of transitioning from a thrice-daily pre-mixed insulin or basal-prandial regimen to insulin degludec/aspart(IDegAsp)therapy,with insufficient ...BACKGROUND There is a lack of clinical evidence on the efficacy and safety of transitioning from a thrice-daily pre-mixed insulin or basal-prandial regimen to insulin degludec/aspart(IDegAsp)therapy,with insufficient data from the Chinese population.AIM To demonstrate the efficacy,safety,and treatment satisfaction associated with the transition to IDegAsp in type 2 diabetes mellitus(T2DM).METHODS In this 12-week open-label,non-randomized,single-center,pilot study,patients with T2DM receiving thrice-daily insulin or intensive insulin treatment were transitioned to twice-daily injections of insulin IDegAsp.Insulin doses,hemoglobin A1c(HbA1c)levels,fasting blood glucose(FBG),hypoglycemic events,a Diabetes Treatment Satisfaction Questionnaire,and other parameters were assessed at baseline and 12-weeks.RESULTS This study included 21 participants.A marked enhancement was observed in the FBG level(P=0.02),daily total insulin dose(P=0.03),and overall diabetes treatment satisfaction(P<0.01)in the participants who switched to IDegAsp.There was a decrease in HbA1c levels(7.6±1.1 vs 7.4±0.9,P=0.31)and the frequency of hypoglycemic events of those who switched to IDegAsp decreased,however,there was no statistically significant difference.CONCLUSION The present findings suggest that treatment with IDegAsp enhances clinical outcomes,particularly FBG levels,daily cumulative insulin dose,and overall satisfaction with diabetes treatment.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
文摘BACKGROUND Gestational diabetes mellitus(GDM)refers to hyperglycemia caused by insulin resistance or insufficient insulin secretion during pregnancy.Patients with GDM have a high risk of pregnancy complications,which can adversely affect both maternal and fetal health.Therefore,early diagnosis,treatment and monitoring of GDM are essential.In recent years,a new treatment scheme represented by insulin aspart combined with metformin has received increasing attention.AIM To explore the effects of insulin aspart combined with metformin on patients with GDM and inflammatory markers.METHODS From April 2020 to September 2022,124 patients with GDM in Sanya Women and Children’s Hospital Managed by Shanghai Children’s Medical Center were collected and analyzed retrospectively.The control group(CG)comprised 62 patients treated with insulin aspart alone,and 62 patients treated with insulin aspart and metformin formed the observation group(OG).Before and after treatment,improvement of blood-glucose-related indexes[fasting blood glucose(FBG),2-h postprandial glucose(2h PG)and hemoglobin A1c(HbA1c)],serum related factor[serum homocysteine(Hcy)],serum inflammatory cytokines[tumor necrosis factor(TNF)-α,interleukin(IL)-6 and C-reactive protein(CRP)]were compared between the two groups.The clinical efficacy,adverse pregnancy outcomes and incidence of pregnancy complications were compared between the two groups.RESULTS After treatment,the levels of FBG,2h PG,HbA1c,Hcy,TNF-α,IL-6 and CRP in both groups were significantly decreased(P<0.05),and the levels of FBG,2h PG,HbA1c,Hcy,TNF-α,IL-6 and CRP in the OG were lower than in the CG(P<0.05).The total clinical effectiveness in the OG was higher than that in the CG(P<0.05).The total incidence of adverse pregnancy outcomes and complications in the OG was significantly lower than in the CG(P<0.05).CONCLUSION Insulin aspart combined with metformin are effective for treatment of GDM,which can reduce blood-glucoserelated indexes,Hcy and serum inflammatory cytokines,and risk of adverse pregnancy outcomes and complications.
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.
基金Supported by CAMS Innovation Fund for Medical Sciences,No.2023-I2M-C&T-B-043National High Level Hospital Clinical Research Funding,No.2022-PUMCH-B-015+1 种基金CAMS Innovation Fund for Medical Sciences,No.2021-1-12M-002Beijing Municipal Natural Science Foundation,No.M22014.
文摘BACKGROUND There is a lack of clinical evidence on the efficacy and safety of transitioning from a thrice-daily pre-mixed insulin or basal-prandial regimen to insulin degludec/aspart(IDegAsp)therapy,with insufficient data from the Chinese population.AIM To demonstrate the efficacy,safety,and treatment satisfaction associated with the transition to IDegAsp in type 2 diabetes mellitus(T2DM).METHODS In this 12-week open-label,non-randomized,single-center,pilot study,patients with T2DM receiving thrice-daily insulin or intensive insulin treatment were transitioned to twice-daily injections of insulin IDegAsp.Insulin doses,hemoglobin A1c(HbA1c)levels,fasting blood glucose(FBG),hypoglycemic events,a Diabetes Treatment Satisfaction Questionnaire,and other parameters were assessed at baseline and 12-weeks.RESULTS This study included 21 participants.A marked enhancement was observed in the FBG level(P=0.02),daily total insulin dose(P=0.03),and overall diabetes treatment satisfaction(P<0.01)in the participants who switched to IDegAsp.There was a decrease in HbA1c levels(7.6±1.1 vs 7.4±0.9,P=0.31)and the frequency of hypoglycemic events of those who switched to IDegAsp decreased,however,there was no statistically significant difference.CONCLUSION The present findings suggest that treatment with IDegAsp enhances clinical outcomes,particularly FBG levels,daily cumulative insulin dose,and overall satisfaction with diabetes treatment.
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,
文摘目的探究不同剂量维生素D联合门冬胰岛素对肥胖妊娠期糖尿病(gestational diabetes mellitus,GDM)患者血糖控制、并发症及胰岛素敏感性的影响。方法方便选取2023年2月—2025年2月南安市医院的82例肥胖GDM患者,按照不同治疗手段分为对照组(n=41,低剂量维生素D联合门冬胰岛素治疗)、观察组(n=41,高剂量维生素D联合门冬胰岛素治疗),对比两组血糖水平(空腹血糖、餐后2 h血糖)、母婴不良结局(巨大儿、早产、产后出血)发生情况、胰岛素敏感指标[胰岛β细胞功能指数(homeostatic model assessment ofβ-cell function,HOMA-β)、胰岛素抵抗指数(homeostatic model assessment of insulin resistance,HOMA-IR)]及临床疗效。结果分娩前空腹血糖、餐后2 h血糖水平显示,观察组均低于对照组,差异均有统计学意义(P均<0.05)。相较于对照组,观察组母婴不良结局总发生率和分娩前HOMA-IR更低,HOMA-β更高,差异均有统计学意义(P均<0.05)。观察组治疗总有效率高于对照组,差异有统计学意义(P<0.05)。结论高剂量维生素D联合门冬胰岛素可更有效改善肥胖GDM患者血糖控制水平,降低并发症发生风险,增强胰岛素敏感性,提升临床疗效。
