Subetta(Subetta) - _专利_临床

概要

基本信息

药物类型

多克隆抗体

别名-

靶点-

作用机制-

治疗领域

内分泌与代谢疾病

在研适应症-

非在研适应症

葡萄糖耐受不良

原研机构

OOO NPF Materia Medica Holding

在研机构-

非在研机构

OOO NPF Materia Medica Holding

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Subetta 相关的临床试验

NCT03725033

/ Completed临床3期

Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance

Purpose of the study:
to assess the efficacy of Subetta in the treatment of impaired glucose tolerance
to assess the safety of Subetta in the treatment of impaired glucose tolerance.

开始日期2018-10-10

申办/合作机构

OOO NPF Materia Medica Holding

NCT01868594

/ Completed临床4期

Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus

The purpose of this study is:
to assess clinical efficacy of Subetta in the combined treatment of type I diabetes mellitus;
to assess safety of Subetta in the combined treatment of type I diabetes mellitus.

开始日期2013-05-07

申办/合作机构

OOO NPF Materia Medica Holding

NCT01868646

/ Completed临床4期

Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus

The purpose of this study is:
to assess clinical efficacy of Subetta in the combined treatment of type II diabetes mellitus;
to assess safety of Subetta in the combined treatment of type II diabetes mellitus.

开始日期2013-05-07

申办/合作机构

OOO NPF Materia Medica Holding

100 项与 Subetta 相关的临床结果

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100 项与 Subetta 相关的转化医学

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100 项与 Subetta 相关的专利（医药）

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10

项与 Subetta 相关的文献（医药）

2019-06-25·International Journal of Endocrinology4区 · 医学

Expression of Concern on “Subetta Treatment Increases Adiponectin Secretion by Mature Human Adipocytes In Vitro”

4区 · 医学

ArticleOA

作者: International Journal of Endocrinology

2019-06-16·Journal of Diabetes Research3区 · 医学

Expression of Concern on “The Novel Oral Drug Subetta Exerts an Antidiabetic Effect in the Diabetic Goto-Kakizaki Rat: Comparison with Rosiglitazone”

3区 · 医学

ArticleOA

作者: Journal of Diabetes Research

2018-08-01·Diabetes Research and Clinical Practice3区 · 医学

Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial

3区 · 医学

Article

作者: Vorobiev, Sergei ; Vorokhobina, Natalia ; Volkova, Anna ; Epstein, Oleg ; Mkrtumyan, Ashot ; Romantsova, Tatyana ; Putilovskiy, Mikhail ; Andrianova, Elena ; Tarasov, Sergey

BACKGROUNDTo examine efficacy of Subetta as an add-on to insulin therapy in patients with type 1 diabetes mellitus (T1DM) a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to insulin receptor β-subunit and endothelial NO synthase Subetta was previously proved to activate insulin signaling pathway.METHODSA total of 144 randomized patients with poor glycemic control in basal-bolus insulin regime were included in intention-to-treat analysis in Subetta add-on therapy or placebo (n = 72 in both groups). Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), basal and prandial insulin doses, number of hypoglycemia episodes confirmed by self-monitoring of blood glucose were recorded for 36 weeks.RESULTSThe baseline characteristics of subjects did not differ between the two groups. HbA1c mean (±standard deviation) change was -0.59 ± 0.99% (95% CI -0.84 to -0.37) after 36 weeks in Subetta (vs. -0.20 ± 1.14%; 95% CI -0.44 to 0.11 in placebo; p = 0.028). The rate of overall hypoglycemia events was 7.9 per patient year (95% CI 7.1-8.6) in Subetta group and 7.6 (95% CI 6.9-8.4) in Placebo group (p = 0.63). The basal and total insulin doses did not change at the end of 36 weeks in both groups.CONCLUSIONSSubetta add-on therapy boosting insulin activity and improving glycemic control in patients with T1DM is proved to be beneficial.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov identifier: NCT01868594.

100 项与 Subetta 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
葡萄糖耐受不良	临床3期	俄罗斯	OOO NPF Materia Medica Holding	2018-10-10

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| J Clin Med 人工标引	临床3期	葡萄糖耐受不良	-	Subetta	(鬱廠鹽衊鏇齋窪淵衊膚) = 醖鏇鹹遞鏇鹹積餘願獵鏇築遞衊襯艱鏇築積淵 (網鏇鏇遞衊選膚築觸繭, 2.11) 更多	积极	2022-03-03
				Placebo	(鬱廠鹽衊鏇齋窪淵衊膚) = 獵壓網鹹繭顧遞遞簾積鏇築遞衊襯艱鏇築積淵 (網鏇鏇遞衊選膚築觸繭, 2.55)
NCT03725033 (CTgov)	临床3期	葡萄糖耐受不良	538	Subetta (Subetta)	簾顧鏇繭積鑰夢壓窪鏇(鬱觸鏇構遞鹽構淵窪鹽) = 壓網製蓋餘衊醖淵齋艱夢糧糧鬱鑰膚膚鏇醖鹽 (憲夢鑰築網鏇選齋鹽醖, 製憲夢鏇選餘壓繭餘築 ~ 淵築觸鬱築積製蓋築壓) 更多	-	2021-01-14
				Placebo (Placebo)	簾顧鏇繭積鑰夢壓窪鏇(鬱觸鏇構遞鹽構淵窪鹽) = 積艱鏇顧窪獵積鏇繭鬱夢糧糧鬱鑰膚膚鏇醖鹽 (憲夢鑰築網鏇選齋鹽醖, 淵膚壓膚願衊醖鏇觸鑰 ~ 餘築積蓋窪窪鑰鏇鏇衊) 更多
NCT01868646 (CTgov)	临床4期	2型糖尿病	190	Subetta (Subetta)	遞簾構選遞憲觸蓋構淵(壓鹹選鹹選壓繭範選顧) = 糧襯築襯膚鏇窪製選衊鹹簾獵衊鬱蓋願製網憲 (壓鹹糧簾壓簾艱網願願, 憲鹽網繭遞糧廠夢壓選 ~ 鑰鹹衊願廠齋選憲範構) 更多	-	2019-03-04
				Placebo (Placebo)	遞簾構選遞憲觸蓋構淵(壓鹹選鹹選壓繭範選顧) = 構衊壓鏇壓鏇膚範鹽醖鹹簾獵衊鬱蓋願製網憲 (壓鹹糧簾壓簾艱網願願, 廠艱夢鏇鹽鏇衊窪夢衊 ~ 齋艱餘窪艱鑰範鏇顧醖) 更多
NCT01868594 (CTgov)	临床4期	1型糖尿病	200	insulins+Subetta (Subetta)	遞齋襯壓積鏇膚襯築範(鬱遞簾夢築範選鏇網鬱) = 衊顧選齋範鬱鹹淵夢糧憲壓築窪鬱膚鬱積顧築 (廠鏇顧觸廠簾獵餘構獵, 廠餘觸醖艱遞鏇壓築鹹 ~ 選膚遞鹽鑰鏇鹽範構淵) 更多	-	2019-03-04
				Placebo (Placebo)	遞齋襯壓積鏇膚襯築範(鬱遞簾夢築範選鏇網鬱) = 網願襯鏇鹹鏇醖夢廠廠憲壓築窪鬱膚鬱積顧築 (廠鏇顧觸廠簾獵餘構獵, 繭壓網獵構簾膚蓋廠鏇 ~ 範網蓋衊築鏇鹽膚廠鏇) 更多