Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.
The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

开始日期2009-07-01

申办/合作机构

Rabin Medical Center

[+1]

100 项与精蛋白重组人胰岛素生物类似药(Popular Pharmaceuticals Ltd.) 相关的临床结果

登录后查看更多信息

100 项与精蛋白重组人胰岛素生物类似药(Popular Pharmaceuticals Ltd.) 相关的转化医学

登录后查看更多信息

100 项与精蛋白重组人胰岛素生物类似药(Popular Pharmaceuticals Ltd.) 相关的专利（医药）

登录后查看更多信息

项与精蛋白重组人胰岛素生物类似药(Popular Pharmaceuticals Ltd.) 相关的文献（医药）

2023-06-01·Diabetes, Obesity and Metabolism

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US‐licensed Humulin® N formulation in healthy subjects: Results from the RHINE‐2 (Recombinant Human INsulin Equivalence‐2) study

Article

作者: Gogineni, Rajesh ; Athalye, Sandeep N. ; Andersen, Grit ; Panda, Jayanti ; Singh, Gursharan ; Murugesan, Sundara Moorthi Nainar ; Marwah, Ashwani ; Sharma, Nirant ; Loganathan, Subramanian

AbstractAimTo establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin‐N; Biocon Biologics Ltd., Bangalore, India) and US‐licensed Humulin® N (Humulin‐N; Eli Lilly and Company, Indianapolis, IN, USA) in healthy subjects.Materials and MethodsThis was a phase‐1, single‐centre, double‐blind, randomized, three‐period, six‐sequence, partially replicated, crossover, 24‐h euglycaemic clamp study. Overall, 90 healthy subjects were randomized, of whom 85 completed the study. The subjects received either two single doses of Biocon's Insulin‐N and a single dose of Humulin‐N or two single doses of Humulin‐N and a single dose of Biocon's Insulin‐N subcutaneously at a dose of 0.4 IU/kg. The primary PK endpoints were the area under the insulin concentration‐time curve from 0 to 24 h (AUCins.0‐24h) and the maximum insulin concentration (Cins.max). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 h (AUCGIR.0‐24h) and the maximum GIR (GIRmax).ResultsBiocon's Insulin‐N was found to be equivalent to Humulin‐N for the primary PK (geometric 90% confidence interval for the least squares mean ratio: AUCins.0‐24h, 100.98%‐115.66% and Cins.max, 95.91%‐110.16%) and PD endpoints (intra‐subject variability ≥0.294; 95% upper confidence interval [(μT – μR)2 − θσ2WR] <0; point estimates of geometric least squares mean ratio: AUCGIR.0‐24h, 104.61% and GIRmax, 100.81%). The safety profile of Biocon's Insulin‐N was similar to that of Humulin‐N, and no serious adverse events were reported.ConclusionPK and PD equivalence was shown between Biocon's Insulin‐N and Humulin‐N in healthy subjects, and both treatments were well tolerated and considered safe.

2018-02-01·Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease2区 · 生物学

Insulin and branched-chain amino acid depletion during mouse preimplantation embryo culture programmes body weight gain and raised blood pressure during early postnatal life

2区 · 生物学

Article

作者: Smith, Stephanie J ; Sheth, Bhavwanti ; Eckert, Judith J ; Velazquez, Miguel A ; Osmond, Clive ; Fleming, Tom P

Mouse maternal low protein diet exclusively during preimplantation development (Emb-LPD) is sufficient to programme altered growth and cardiovascular dysfunction in offspring. Here, we use an in vitro model comprising preimplantation culture in medium depleted in insulin and branched-chain amino acids (BCAA), two proposed embryo programming inductive factors from Emb-LPD studies, to examine the consequences for blastocyst organisation and, after embryo transfer (ET), postnatal disease origin. Two-cell embryos were cultured to blastocyst stage in defined KSOM medium supplemented with four combinations of insulin and BCAA concentrations. Control medium contained serum insulin and uterine luminal fluid amino acid concentrations (including BCAA) found in control mothers from the maternal diet model (N-insulin+N-bcaa). Experimental medium (three groups) contained 50% reduction in insulin and/or BCAA (L-insulin+N-bcaa, N-insulin+L-bcaa, and L-insulin+N-bcaa). Lineage-specific cell numbers of resultant blastocysts were not affected by treatment. Following ET, a combined depletion of insulin and BCAA during embryo culture induced a non sex-specific increase in birth weight and weight gain during early postnatal life. Furthermore, male offspring displayed relative hypertension and female offspring reduced heart/body weight, both characteristics of Emb-LPD offspring. Combined depletion of metabolites also resulted in a strong positive correlation between body weight and glucose metabolism that was absent in the control group. Our results support the notion that composition of preimplantation culture medium can programme development and associate with disease origin affecting postnatal growth and cardiovascular phenotypes and implicate two important nutritional mediators in the inductive mechanism. Our data also have implications for human assisted reproductive treatment (ART) practice.

2011-08-01·Asian Pacific Journal of Tropical Biomedicine4区 · 医学

Effect of insulin on Blattela germanica Linnacus

4区 · 医学

ArticleOA

作者: M Davoudi ; M Abolhasani ; SH Moosa Kazem ; E Abolghasemi

OBJECTIVETo determine the sensitivity of Blattela germanica L (B. germanica L) to differenct doses of insulin.METHODSB. germanica were reared in laboratory conditions at (25±2) °C and (50±5)% relative humidity (RH), and exposure period of 12:12 L/D. Different concentrations, viz. 5, 10, 15, 20 and 25 µ of insulin N, R, (N+R) were prepared and injected to 10 treated cockroaches with another 10 cockroaches which were injected with normal saline as control group.RESULTSInsulin N with a dose of 20 µ caused more than 70% mortality of B. germanica in this study. There was a significant difference between 20 µ of insulin N with other doses of 5, 10, 15 and 25 µ, and its comparison with other forms of medication also showed obvious difference (P<0.05).CONCLUSIONSIt can be concluded that effective drug doses of insulin which can be used as posion bait or gel against German cockroaches could be utilized in the control of B. germanica in the future field studies.

100 项与精蛋白重组人胰岛素生物类似药(Popular Pharmaceuticals Ltd.) 相关的药物交易

登录后查看更多信息