Objective:To evaluate the efficacy and safety of different basal insulins in the treatment of type 2 diabetes mellitus(T2DM).Methods:The current research progress on different basal insulins was evaluated,with efficac...Objective:To evaluate the efficacy and safety of different basal insulins in the treatment of type 2 diabetes mellitus(T2DM).Methods:The current research progress on different basal insulins was evaluated,with efficacy indicators including fasting plasma glucose(FPG)and glycated hemoglobin(HbAic),and safety indicators focusing mainly on weight change and the incidence of hypoglycemia.Results:Several different basal insulins showed similar metabolic control effects in terms of fasting plasma glucose and glycated hemoglobin.However,the risk of hypoglycemia was lower with insulin glargine 300(Glar-300),insulin degludec 100(Deg-100),and insulin degludec 200(Deg-200)compared to insulin glargine 100(Glar-100).Additionally,Glar-300 had the least impact on weight.Conclusion:For the treatment of T2DM,different basal insulins have similar therapeutic effects,but there are differences in the incidence of hypoglycemic events and their impact on weight.Rational insulin selection and dosage adjustments should be made based on the different patient groups.展开更多
AIM To compare the safety and efficacy or 3 basal-bolus regimens of neutral protamine hagedorn(NPH)/regular insulin in the management of inpatient hyperglycemia.METHODS We randomized 105 patients with blood glucose le...AIM To compare the safety and efficacy or 3 basal-bolus regimens of neutral protamine hagedorn(NPH)/regular insulin in the management of inpatient hyperglycemia.METHODS We randomized 105 patients with blood glucose levelsbetween 140 and 400 mg/dL to a basal-bolus regimen of NPH insulin given once(n = 30), twice(n = 40) or three times(n = 35) daily, in addition to pre-meal regular insulin. Major outcomes included were differences in glycemic control, frequency of hypoglycemia and total insulin dose.RESULTS NPH insulin given in a once-daily regimen was associated with better glycemic control(58.3%) compared to twice daily(42.4%) and three times daily(48.9) regimens(P = 0.031). The frequency of hypoglycemia was similar between the three groups(2.0%, 0.7% and 1.2%, P = 0.21). The mean insulin dose at discharge was 0.48 ± 0.14 U/kg in the once-daily group compared to 0.69 ± 0.28 in the twice-daily, and 0.65 ± 0.20 in the three times daily regimens(P < 0.001).CONCLUSION NPH insulin administered in a once-daily regimen resulted in improvement in glycemic control with similar rates of hypoglycemia compared to a twice-daily and a three times-daily regimen. Further studies are needed to evaluate whether this regimen could be implemented in all hospitalized patients with hyperglycemia.展开更多
目的 分析德谷门冬双胰岛素、基础-餐时胰岛素短期强化治疗对新诊断2型糖尿病(T2DM)患者血糖控制的影响。方法 选取60例新诊断T2DM患者为研究对象,依据随机数字法分为对照组(30例,德谷门冬双胰岛素治疗)、研究组(30例,基础-餐时胰岛素...目的 分析德谷门冬双胰岛素、基础-餐时胰岛素短期强化治疗对新诊断2型糖尿病(T2DM)患者血糖控制的影响。方法 选取60例新诊断T2DM患者为研究对象,依据随机数字法分为对照组(30例,德谷门冬双胰岛素治疗)、研究组(30例,基础-餐时胰岛素短期强化治疗)。对比两组患者的血糖指标[糖化血红蛋白(HbA1c)、空腹血糖(FPG)和餐后2 h血糖(2 h PBG)],血糖控制情况(血糖达标时间、血糖波动水平)和低血糖发生率,治疗效果。结果 两组治疗前HbA1c、FPG和2 h PBG水平对比无显著差异(P>0.05);治疗后,研究组HbA1c(6.08±0.76)%、FPG(5.71±0.59)mmol/L和2 h PBG(7.53±0.96)mmol/L比对照组的(8.19±1.14)%、(6.86±0.84)mmol/L、(9.38±1.33)mmol/L低,差异具有统计学意义(P<0.05)。研究组患者血糖达标时间为(6.95±1.61)d、血糖波动为(2.25±0.35)mmol/L、夜间低血糖发生率为0;对照组患者血糖达标时间为(8.26±1.56)d、血糖波动为(3.12±0.68)mmol/L、夜间低血糖发生率为20.00%;研究组患者的血糖达标时间、血糖波动水平和低血糖发生率均显著低于对照组,差异具有统计学意义(P<0.05)。研究组患者的治疗总有效率(100.00%)显著高于对照组(80.00%),差异具有统计学意义(P<0.05)。结论 对于新诊断T2DM患者来说,基础-餐时胰岛素短期强化治疗相对于德谷门冬双胰岛素疗效较好,值得推广。展开更多
AIM:To evaluate the safety of four insulin titration algorithms in a homogeneous population of insulin-na ve type 2 diabetic patients.METHODS:We conducted a 24-wk,open,single-center study with 92 insulin-na ve type 2 ...AIM:To evaluate the safety of four insulin titration algorithms in a homogeneous population of insulin-na ve type 2 diabetic patients.METHODS:We conducted a 24-wk,open,single-center study with 92 insulin-na ve type 2 diabetes patients who failed treatment with one or two oral drugs.The patients were randomized to one of the four following algorithms:LANMET(n=26)and LANMET PLUS(n=22)algorithms,whose patients received a fixed initial insulin dose of 10 U,and DeGold(n=23)and DeGold PLUS(n=21)algorithms,whose patients’initial insulin dose was based on their body mass index(BMI).In addition,patients in the PLUS groups had their insulin titrated twice a week from 2 to 8 U.In the other two groups,the titration was also performed also twice a week,but in a fixed increments of 2 U.The target fasting glucose levels for both groups was 100 mg/dL.RESULTS:There was no significant difference in efficacy parameters.There was no significant difference when comparing moderate hypoglycemia events in algorithms starting with a 10 U fixed dose and algorithms based on BMI.However,there was a significant increase in moderate hypoglycemia events among the PLUS treated patients when the LANMET and DeGold algorithms were compared with the 2 fast-titration PLUS algorithms.We observed 12 hypoglycemia events in the first group,which corresponded to 0.94 events/patient per year,and we observed 42 events in the second group,which corresponded to 2.81 events/patient per year(P<0.037).No further significant differences were observed when other comparisons between the algorithms were carried out.CONCLUSION:Starting insulin glargine based on BMI is safe,but fast titration algorithms increase the risk of moderate hypoglycemia.展开更多
Background: Hyperglycemia in hospitalized patients is associated with poor clinical outcomes. Scheduled Subcutaneous Insulin therapy has been recommended for better glycemic control. Aims: To compare efficacy and safe...Background: Hyperglycemia in hospitalized patients is associated with poor clinical outcomes. Scheduled Subcutaneous Insulin therapy has been recommended for better glycemic control. Aims: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus basal plus supplemental scale (SS) insulin regimens for glycemic control of inpatients with diabetes. Methods: In a prospective trial, 62 patients with diabetes were randomized to receive either hospital SSI (N = 22), or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL (N = 21) or once every night glargine plus prandial glulisine for BG ≥ 150 mg/dL (N = 19). 70/30 insulin and glargine were started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL. Results: Starting at BG level of 204 ± 68, 200 ± 50 and 241 ± 94 mg/dL in SSI, 70/30 insulin and glargine/glulisine groups respectively, (F(2,35.47) = 1.467, p = 0.244, Welch test), mean daily BG after first day of hospitalization was statistically significant (F(2,35.58) = 7.043, p = 0.003, Welch test) lower in 70/30 insulin group (171 ± 38 mg/dL) compared to (218 ± 71 mg/dL) in SSI group (p = 0.026) and (225 ± 65 mg/dL) in glargine/glulisine group (p = 0.01). Conclusions: With poorly educated nursing staff, basal plus SS insulin failed to provide adequate glycemic control. However, tailored 70/30 insulin regimen resulted in statistically significant glycemic control compared to traditional SSI.展开更多
Objective: Evidence supporting the twice-daily administration of insulin glargine as an approach to address its waning effectiveness at the end of a 24 hour period is sparse. We hypothesized that insulin concentration...Objective: Evidence supporting the twice-daily administration of insulin glargine as an approach to address its waning effectiveness at the end of a 24 hour period is sparse. We hypothesized that insulin concentrations determined during the last four hours of a 24 hour period would be greater when identical doses of insulin glargine were administered twice-daily as compared to once-daily among type 1 diabetes patients. Research Methods: Ten subjects with insulin deficient type 1 diabetes were admitted for two 38-hour studies at least one week apart. Patients received full-dose insulin glargine once daily at 0800 and half-dose insulin glargine twice-daily at 0800 and 2000 for at least one week in random order prior to overnight studies. Overnight glucose was stabilized with intravenous insulin on the evening prior to study, and subjects fasted and did not receive short acting insulin during the study period. Insulin concentrations were assessed every 30 minutes with an ultrasensitive assay between study hours 20 and 24. Results: Insulin concentrations for the final four hours of study period did not differ between once-daily and twice-daily insulin glargine administration (p = 0.38). Home glucose testing results and overnight plasma glucose concentrations did not differ between study conditions. Conclusions: These results demonstrate that insulin concentrations are equivalent during the last four hours of a 24-hour period when insulin glargine is administered once- or twice-daily. These findings do not support a role for twice-daily insulin glargine in the management of patients with type 1 diabetes.展开更多
Aim: To assess the safety and efficacy of basal-supported prandial GLP-1 receptor agonist therapy (BPT)* in type 2 diabetes mellitus (T2DM). Methods: Patients with T2DM, who had previously received insulin injection t...Aim: To assess the safety and efficacy of basal-supported prandial GLP-1 receptor agonist therapy (BPT)* in type 2 diabetes mellitus (T2DM). Methods: Patients with T2DM, who had previously received insulin injection therapy and who had had their treatment switched to BPT (liraglutide), were retrospectively recruited. The efficacy of BPT was assessed by determining changes in HbA1c, body weight and total daily insulin dose from baseline to 4 months after BPT initiation. Safety was assessed by comparing the frequency of hypoglycemic episodes at baseline and after 4 months. The Wilcoxon test was used to analyze changes in parameters throughout the study period. Results: Twenty-nine patients, previously treated with basal-supported oral therapy (BOT), basal-bolus insulin, or pre-mixed insulin, were recruited. When analyzed together, there was no change in HbA1c throughout the study period, but body weight decreased (baseline 68.8 ± 13.2 kg vs. month 4 67.3 ± 13.1 kg;p < 0.001). Total daily insulin dose decreased after 4 months (baseline 24.4 ± 15.5 U/day vs. month 4 14.7 ± 9.2 U/day;p < 0.001), and there was no change in the frequency of hypoglycemic episodes. Analysis was conducted within sub-groups based on previous treatment modality. In the BOT group, HbA1c decreased from baseline after 2 months and body weight did not change throughout the study period. In both the basal-bolus insulin group and the pre-mixed insulin group, HbA1c remained steady throughout and there was a decrease in body weight. No change in the frequency of hypoglycemia was observed in any of the sub-groups. Conclusion: BPT in T2DM was associated with weight loss without changes in glycemic control over 4 months, suggesting that it may be an effective and safe therapy.展开更多
Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a hi...Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a high-burden disease in Nepal with a prevalence of 8.4%. Of these 8% - 18% patients are on insulin and 42% patients were reported to have uncontrolled diabetes in the past year. This suggests a need for better therapy options in terms of efficacy and safety. The current study was designed to investigate the effects of Insulin glargine-based therapy in Nepalese with T2DM who could not achieve adequate glycemic control with oral and non-glargine-insulin therapy. Methods: This is a prospective, multi-centric, single arm and post marketing observational study to assess the safety and effectiveness of Glaritus®(Wockhardt’s Insulin Glargine) in 52 T2DM patients from 3 (three) different study sites in Nepal (Bharatpur, Kathmandu and Pokhra) from September 2015 to December 2016. The primary objective of the study was to evaluate the safety of Glaritus®, mainly in terms of hypoglycemia, renal function tests and liver function tests. The secondary objectives were to evaluate the effectiveness of Glaritus®in terms of percentage of patients achieving HbA1c goal of less than 7%, mean changes in HbA1c & fasting plasma glucose (FPG) levels from baseline till the end of study. Results: 3.85% of subjects experienced hypoglycemia during first 3 months of therapy whereas 1.92% had similar experience in next 3 months of therapy. The mean HbA1c values reduced from 9.16% to 7.15% at the end of study. 21.05% of the enrolled subjects achieved the goal of HbA1c ®was well tolerated by the study patients. Conclusion: In patients with type 2 diabetes mellitus inadequately controlled on oral hypoglycemic agents and/or insulin, initiation with Glaritus®significantly improved glycemic control with good tolerability and acceptability. This analysis in T2DM Nepalese patients shows that by significantly improving glycemic control while not increasing risk of hypoglycemia, Glaritus®provides safer basal insulin and may be suited to aggressive treatment regimens. From a societal perspective, it will help more patients reach the glycemic control target as recommended by the current treatment guidelines.展开更多
Objective: To observe the value of HbA1c level evaluating the total daily basal insulin dose by continuous subcuta- neous insulin infusion (CSII) in 268 patients with type 2 diabetes mellitus. Methods: 5-point capilla...Objective: To observe the value of HbA1c level evaluating the total daily basal insulin dose by continuous subcuta- neous insulin infusion (CSII) in 268 patients with type 2 diabetes mellitus. Methods: 5-point capillary blood glucose was moni- tored in pre- and post-CSII and the insulin dose which could stabilize blood glucose was defined as the total daily dose of insulin, including basal and bolus total dose. Correlation between HbA1c level and total daily dose of insulin in patients with type 2 dia- betes mellitus was analyzed. Correlation between HbA1c level and 5-point capillary blood glucose was also analyzed. Results: Obvious correlation was observed between HbA1c level and the basal total daily dose of insulin if HbA1c was more than 9.3% (r=0.635, P<0.05). The average of 5-point capillary blood glucose was best correlated with HbA1c and fasting blood glucose next best. Conclusion: HbA1c level can forecast basal total daily dose of insulin in CSII.展开更多
基金Health Research Project of the Kunming Municipal Health Commission(Project No.2022-03-06-015)。
文摘Objective:To evaluate the efficacy and safety of different basal insulins in the treatment of type 2 diabetes mellitus(T2DM).Methods:The current research progress on different basal insulins was evaluated,with efficacy indicators including fasting plasma glucose(FPG)and glycated hemoglobin(HbAic),and safety indicators focusing mainly on weight change and the incidence of hypoglycemia.Results:Several different basal insulins showed similar metabolic control effects in terms of fasting plasma glucose and glycated hemoglobin.However,the risk of hypoglycemia was lower with insulin glargine 300(Glar-300),insulin degludec 100(Deg-100),and insulin degludec 200(Deg-200)compared to insulin glargine 100(Glar-100).Additionally,Glar-300 had the least impact on weight.Conclusion:For the treatment of T2DM,different basal insulins have similar therapeutic effects,but there are differences in the incidence of hypoglycemic events and their impact on weight.Rational insulin selection and dosage adjustments should be made based on the different patient groups.
文摘AIM To compare the safety and efficacy or 3 basal-bolus regimens of neutral protamine hagedorn(NPH)/regular insulin in the management of inpatient hyperglycemia.METHODS We randomized 105 patients with blood glucose levelsbetween 140 and 400 mg/dL to a basal-bolus regimen of NPH insulin given once(n = 30), twice(n = 40) or three times(n = 35) daily, in addition to pre-meal regular insulin. Major outcomes included were differences in glycemic control, frequency of hypoglycemia and total insulin dose.RESULTS NPH insulin given in a once-daily regimen was associated with better glycemic control(58.3%) compared to twice daily(42.4%) and three times daily(48.9) regimens(P = 0.031). The frequency of hypoglycemia was similar between the three groups(2.0%, 0.7% and 1.2%, P = 0.21). The mean insulin dose at discharge was 0.48 ± 0.14 U/kg in the once-daily group compared to 0.69 ± 0.28 in the twice-daily, and 0.65 ± 0.20 in the three times daily regimens(P < 0.001).CONCLUSION NPH insulin administered in a once-daily regimen resulted in improvement in glycemic control with similar rates of hypoglycemia compared to a twice-daily and a three times-daily regimen. Further studies are needed to evaluate whether this regimen could be implemented in all hospitalized patients with hyperglycemia.
文摘目的 分析德谷门冬双胰岛素、基础-餐时胰岛素短期强化治疗对新诊断2型糖尿病(T2DM)患者血糖控制的影响。方法 选取60例新诊断T2DM患者为研究对象,依据随机数字法分为对照组(30例,德谷门冬双胰岛素治疗)、研究组(30例,基础-餐时胰岛素短期强化治疗)。对比两组患者的血糖指标[糖化血红蛋白(HbA1c)、空腹血糖(FPG)和餐后2 h血糖(2 h PBG)],血糖控制情况(血糖达标时间、血糖波动水平)和低血糖发生率,治疗效果。结果 两组治疗前HbA1c、FPG和2 h PBG水平对比无显著差异(P>0.05);治疗后,研究组HbA1c(6.08±0.76)%、FPG(5.71±0.59)mmol/L和2 h PBG(7.53±0.96)mmol/L比对照组的(8.19±1.14)%、(6.86±0.84)mmol/L、(9.38±1.33)mmol/L低,差异具有统计学意义(P<0.05)。研究组患者血糖达标时间为(6.95±1.61)d、血糖波动为(2.25±0.35)mmol/L、夜间低血糖发生率为0;对照组患者血糖达标时间为(8.26±1.56)d、血糖波动为(3.12±0.68)mmol/L、夜间低血糖发生率为20.00%;研究组患者的血糖达标时间、血糖波动水平和低血糖发生率均显著低于对照组,差异具有统计学意义(P<0.05)。研究组患者的治疗总有效率(100.00%)显著高于对照组(80.00%),差异具有统计学意义(P<0.05)。结论 对于新诊断T2DM患者来说,基础-餐时胰岛素短期强化治疗相对于德谷门冬双胰岛素疗效较好,值得推广。
文摘AIM:To evaluate the safety of four insulin titration algorithms in a homogeneous population of insulin-na ve type 2 diabetic patients.METHODS:We conducted a 24-wk,open,single-center study with 92 insulin-na ve type 2 diabetes patients who failed treatment with one or two oral drugs.The patients were randomized to one of the four following algorithms:LANMET(n=26)and LANMET PLUS(n=22)algorithms,whose patients received a fixed initial insulin dose of 10 U,and DeGold(n=23)and DeGold PLUS(n=21)algorithms,whose patients’initial insulin dose was based on their body mass index(BMI).In addition,patients in the PLUS groups had their insulin titrated twice a week from 2 to 8 U.In the other two groups,the titration was also performed also twice a week,but in a fixed increments of 2 U.The target fasting glucose levels for both groups was 100 mg/dL.RESULTS:There was no significant difference in efficacy parameters.There was no significant difference when comparing moderate hypoglycemia events in algorithms starting with a 10 U fixed dose and algorithms based on BMI.However,there was a significant increase in moderate hypoglycemia events among the PLUS treated patients when the LANMET and DeGold algorithms were compared with the 2 fast-titration PLUS algorithms.We observed 12 hypoglycemia events in the first group,which corresponded to 0.94 events/patient per year,and we observed 42 events in the second group,which corresponded to 2.81 events/patient per year(P<0.037).No further significant differences were observed when other comparisons between the algorithms were carried out.CONCLUSION:Starting insulin glargine based on BMI is safe,but fast titration algorithms increase the risk of moderate hypoglycemia.
文摘Background: Hyperglycemia in hospitalized patients is associated with poor clinical outcomes. Scheduled Subcutaneous Insulin therapy has been recommended for better glycemic control. Aims: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus basal plus supplemental scale (SS) insulin regimens for glycemic control of inpatients with diabetes. Methods: In a prospective trial, 62 patients with diabetes were randomized to receive either hospital SSI (N = 22), or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL (N = 21) or once every night glargine plus prandial glulisine for BG ≥ 150 mg/dL (N = 19). 70/30 insulin and glargine were started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL. Results: Starting at BG level of 204 ± 68, 200 ± 50 and 241 ± 94 mg/dL in SSI, 70/30 insulin and glargine/glulisine groups respectively, (F(2,35.47) = 1.467, p = 0.244, Welch test), mean daily BG after first day of hospitalization was statistically significant (F(2,35.58) = 7.043, p = 0.003, Welch test) lower in 70/30 insulin group (171 ± 38 mg/dL) compared to (218 ± 71 mg/dL) in SSI group (p = 0.026) and (225 ± 65 mg/dL) in glargine/glulisine group (p = 0.01). Conclusions: With poorly educated nursing staff, basal plus SS insulin failed to provide adequate glycemic control. However, tailored 70/30 insulin regimen resulted in statistically significant glycemic control compared to traditional SSI.
文摘Objective: Evidence supporting the twice-daily administration of insulin glargine as an approach to address its waning effectiveness at the end of a 24 hour period is sparse. We hypothesized that insulin concentrations determined during the last four hours of a 24 hour period would be greater when identical doses of insulin glargine were administered twice-daily as compared to once-daily among type 1 diabetes patients. Research Methods: Ten subjects with insulin deficient type 1 diabetes were admitted for two 38-hour studies at least one week apart. Patients received full-dose insulin glargine once daily at 0800 and half-dose insulin glargine twice-daily at 0800 and 2000 for at least one week in random order prior to overnight studies. Overnight glucose was stabilized with intravenous insulin on the evening prior to study, and subjects fasted and did not receive short acting insulin during the study period. Insulin concentrations were assessed every 30 minutes with an ultrasensitive assay between study hours 20 and 24. Results: Insulin concentrations for the final four hours of study period did not differ between once-daily and twice-daily insulin glargine administration (p = 0.38). Home glucose testing results and overnight plasma glucose concentrations did not differ between study conditions. Conclusions: These results demonstrate that insulin concentrations are equivalent during the last four hours of a 24-hour period when insulin glargine is administered once- or twice-daily. These findings do not support a role for twice-daily insulin glargine in the management of patients with type 1 diabetes.
文摘Aim: To assess the safety and efficacy of basal-supported prandial GLP-1 receptor agonist therapy (BPT)* in type 2 diabetes mellitus (T2DM). Methods: Patients with T2DM, who had previously received insulin injection therapy and who had had their treatment switched to BPT (liraglutide), were retrospectively recruited. The efficacy of BPT was assessed by determining changes in HbA1c, body weight and total daily insulin dose from baseline to 4 months after BPT initiation. Safety was assessed by comparing the frequency of hypoglycemic episodes at baseline and after 4 months. The Wilcoxon test was used to analyze changes in parameters throughout the study period. Results: Twenty-nine patients, previously treated with basal-supported oral therapy (BOT), basal-bolus insulin, or pre-mixed insulin, were recruited. When analyzed together, there was no change in HbA1c throughout the study period, but body weight decreased (baseline 68.8 ± 13.2 kg vs. month 4 67.3 ± 13.1 kg;p < 0.001). Total daily insulin dose decreased after 4 months (baseline 24.4 ± 15.5 U/day vs. month 4 14.7 ± 9.2 U/day;p < 0.001), and there was no change in the frequency of hypoglycemic episodes. Analysis was conducted within sub-groups based on previous treatment modality. In the BOT group, HbA1c decreased from baseline after 2 months and body weight did not change throughout the study period. In both the basal-bolus insulin group and the pre-mixed insulin group, HbA1c remained steady throughout and there was a decrease in body weight. No change in the frequency of hypoglycemia was observed in any of the sub-groups. Conclusion: BPT in T2DM was associated with weight loss without changes in glycemic control over 4 months, suggesting that it may be an effective and safe therapy.
文摘Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a high-burden disease in Nepal with a prevalence of 8.4%. Of these 8% - 18% patients are on insulin and 42% patients were reported to have uncontrolled diabetes in the past year. This suggests a need for better therapy options in terms of efficacy and safety. The current study was designed to investigate the effects of Insulin glargine-based therapy in Nepalese with T2DM who could not achieve adequate glycemic control with oral and non-glargine-insulin therapy. Methods: This is a prospective, multi-centric, single arm and post marketing observational study to assess the safety and effectiveness of Glaritus®(Wockhardt’s Insulin Glargine) in 52 T2DM patients from 3 (three) different study sites in Nepal (Bharatpur, Kathmandu and Pokhra) from September 2015 to December 2016. The primary objective of the study was to evaluate the safety of Glaritus®, mainly in terms of hypoglycemia, renal function tests and liver function tests. The secondary objectives were to evaluate the effectiveness of Glaritus®in terms of percentage of patients achieving HbA1c goal of less than 7%, mean changes in HbA1c & fasting plasma glucose (FPG) levels from baseline till the end of study. Results: 3.85% of subjects experienced hypoglycemia during first 3 months of therapy whereas 1.92% had similar experience in next 3 months of therapy. The mean HbA1c values reduced from 9.16% to 7.15% at the end of study. 21.05% of the enrolled subjects achieved the goal of HbA1c ®was well tolerated by the study patients. Conclusion: In patients with type 2 diabetes mellitus inadequately controlled on oral hypoglycemic agents and/or insulin, initiation with Glaritus®significantly improved glycemic control with good tolerability and acceptability. This analysis in T2DM Nepalese patients shows that by significantly improving glycemic control while not increasing risk of hypoglycemia, Glaritus®provides safer basal insulin and may be suited to aggressive treatment regimens. From a societal perspective, it will help more patients reach the glycemic control target as recommended by the current treatment guidelines.
文摘Objective: To observe the value of HbA1c level evaluating the total daily basal insulin dose by continuous subcuta- neous insulin infusion (CSII) in 268 patients with type 2 diabetes mellitus. Methods: 5-point capillary blood glucose was moni- tored in pre- and post-CSII and the insulin dose which could stabilize blood glucose was defined as the total daily dose of insulin, including basal and bolus total dose. Correlation between HbA1c level and total daily dose of insulin in patients with type 2 dia- betes mellitus was analyzed. Correlation between HbA1c level and 5-point capillary blood glucose was also analyzed. Results: Obvious correlation was observed between HbA1c level and the basal total daily dose of insulin if HbA1c was more than 9.3% (r=0.635, P<0.05). The average of 5-point capillary blood glucose was best correlated with HbA1c and fasting blood glucose next best. Conclusion: HbA1c level can forecast basal total daily dose of insulin in CSII.