Objective: The present study assessed safety and efficacy of Glaritus®among adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective, randomized, multicenter, comparative, non-inferiority, op...Objective: The present study assessed safety and efficacy of Glaritus®among adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective, randomized, multicenter, comparative, non-inferiority, open-label, parallel group, phase IV study was conducted in 14 study centers in India. Subjects were randomly allocated to receive either Glaritus®or Lantus®for 12 weeks. Each week, the dose of insulin was titrated to maintain target fasting blood glucose (FBG) level range of 80 - 120 mg/dL. Results: A total of 171 subjects were randomized (Glaritus®arm-86;Lantus®arm-85) and 161 subjects completed the study. The mean change in the glycosylated haemoglobin (HbA1c) levels from visit 3 (baseline) to visit 6 (end of trial) in Glaritus®arm was -0.69 ± 1.81 and in Lantus®arm was -0.53 ± 1.94. The mean change in glucose levels between week 1 and end of week 11 in Glaritus®arm was -8.81 ± 34.57 and in Lantus®arm was -5.28 ± 30. At least one hypoglycemic episode was experienced by 27.2% subjects of Glaritus®arm and 28.6% subjects of Lantus®arm. A total of 24 adverse events (AEs) such as pain, pyrexia, few infection related including urinary tract infections, metabolic related such as decreased appetite, musculoskeletal, neurological and skin related were reported in the study (Lantus®arm: 14 AEs;Glaritus®arm: 10 AEs). Conclusion: In this short term, 12-week study, biosimilar insulin glargine, Glaritus®, is comparable to the reference product, Lantus®, when combined with Insulin Lispro®in terms of glycemic control, risk of hypoglycemia and occurrence of adverse drug reactions among adults with T1DM.展开更多
Ultra rapid lispro(URLi)is a novel formulation of insulin lispro designed to more closely match the physiological insulin response to a meal,with the aim of improving postprandial glucose(PPG)control.We conducted a mu...Ultra rapid lispro(URLi)is a novel formulation of insulin lispro designed to more closely match the physiological insulin response to a meal,with the aim of improving postprandial glucose(PPG)control.We conducted a multinational,multicenter,randomized,double-blind,treat-to-target,26-week,phase 3 trial to evaluate the efficacy and safety of URLi in adults with type 2 diabetes(T2D).After an 8-week lead-in period during which basal insulin glargine or degludec was optimized,adults with T2D were randomized(2:1)to prandial URLi(n=395)or lispro(n=200).The primary endpoint was non-inferiority of URLi versus lispro in glycated hemoglobin A1c(HbA_(1c))change from baseline to week 26.Multiplicity-adjusted analyses were performed to assess the superiority of URLi in 1-and 2-h PPG excursions during a mixed-meal tolerance test(MMTT)and HbA_(1c) change at week 26.URLi showed non-inferiority for Hb Achange at week 26 versus lispro(least-squares mean[LSM]difference,0.07%;95%confidence interval:-0.07,0.21).HbA_(1c) was reduced by 0.56%and 0.63%with URLi and lispro,respectively,with no significant treatment difference(P=0.321).URLi provided superior PPG excursion control versus lispro at1 h(LSM difference:-14.6 mg/d L,P<0.001)and 2 h(LSM difference:-21.8 mg/d L,P<0.001)as well as other time points(30–240 min)during the MMTT.Incremental area under the glucose curve during the MMTT was also significantly lower with URLi versus lispro.The safety profiles were generally similar between treatment groups.In conclusion,URLi was superior to lispro for PPG control,with noninferiority in HbA_(1c) improvement,in adults with T2D.展开更多
文摘Objective: The present study assessed safety and efficacy of Glaritus®among adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective, randomized, multicenter, comparative, non-inferiority, open-label, parallel group, phase IV study was conducted in 14 study centers in India. Subjects were randomly allocated to receive either Glaritus®or Lantus®for 12 weeks. Each week, the dose of insulin was titrated to maintain target fasting blood glucose (FBG) level range of 80 - 120 mg/dL. Results: A total of 171 subjects were randomized (Glaritus®arm-86;Lantus®arm-85) and 161 subjects completed the study. The mean change in the glycosylated haemoglobin (HbA1c) levels from visit 3 (baseline) to visit 6 (end of trial) in Glaritus®arm was -0.69 ± 1.81 and in Lantus®arm was -0.53 ± 1.94. The mean change in glucose levels between week 1 and end of week 11 in Glaritus®arm was -8.81 ± 34.57 and in Lantus®arm was -5.28 ± 30. At least one hypoglycemic episode was experienced by 27.2% subjects of Glaritus®arm and 28.6% subjects of Lantus®arm. A total of 24 adverse events (AEs) such as pain, pyrexia, few infection related including urinary tract infections, metabolic related such as decreased appetite, musculoskeletal, neurological and skin related were reported in the study (Lantus®arm: 14 AEs;Glaritus®arm: 10 AEs). Conclusion: In this short term, 12-week study, biosimilar insulin glargine, Glaritus®, is comparable to the reference product, Lantus®, when combined with Insulin Lispro®in terms of glycemic control, risk of hypoglycemia and occurrence of adverse drug reactions among adults with T1DM.
文摘Ultra rapid lispro(URLi)is a novel formulation of insulin lispro designed to more closely match the physiological insulin response to a meal,with the aim of improving postprandial glucose(PPG)control.We conducted a multinational,multicenter,randomized,double-blind,treat-to-target,26-week,phase 3 trial to evaluate the efficacy and safety of URLi in adults with type 2 diabetes(T2D).After an 8-week lead-in period during which basal insulin glargine or degludec was optimized,adults with T2D were randomized(2:1)to prandial URLi(n=395)or lispro(n=200).The primary endpoint was non-inferiority of URLi versus lispro in glycated hemoglobin A1c(HbA_(1c))change from baseline to week 26.Multiplicity-adjusted analyses were performed to assess the superiority of URLi in 1-and 2-h PPG excursions during a mixed-meal tolerance test(MMTT)and HbA_(1c) change at week 26.URLi showed non-inferiority for Hb Achange at week 26 versus lispro(least-squares mean[LSM]difference,0.07%;95%confidence interval:-0.07,0.21).HbA_(1c) was reduced by 0.56%and 0.63%with URLi and lispro,respectively,with no significant treatment difference(P=0.321).URLi provided superior PPG excursion control versus lispro at1 h(LSM difference:-14.6 mg/d L,P<0.001)and 2 h(LSM difference:-21.8 mg/d L,P<0.001)as well as other time points(30–240 min)during the MMTT.Incremental area under the glucose curve during the MMTT was also significantly lower with URLi versus lispro.The safety profiles were generally similar between treatment groups.In conclusion,URLi was superior to lispro for PPG control,with noninferiority in HbA_(1c) improvement,in adults with T2D.
