精蛋白人胰岛素（诺和诺德）(Isophane Protamine Human Insulin(Novo Nordisk A/S)) - 药物靶点：INSR_在研适应症：糖尿病_专利_临床

概要

基本信息

药物类型

重组蛋白

别名

Insulin NPH(Novo Nordisk A/S)、Neutral Protamine Hagedorn Insulin(Novo Nordisk A/S)、Novolin N

+ [1]

靶点

INSR

作用机制

INSR激动剂(胰岛素受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)批准上市

特殊审评-

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关联

29

项与精蛋白人胰岛素（诺和诺德）相关的临床试验

NCT06619301

/ Recruiting临床3期IIT

Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

开始日期2024-04-01

申办/合作机构

Loyola University Medical Center

NCT01970241

/ Completed临床4期IIT

Inpatient Diabetes on Corticosteroids

Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

开始日期2014-07-01

申办/合作机构

Hennepin Healthcare Research Institute

[+1]

NCT00821795

/ Completed临床4期

Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy

Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions:
To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital.
To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.

开始日期2009-03-11

申办/合作机构

Lexington Va Medical Center

[+1]

100 项与精蛋白人胰岛素（诺和诺德）相关的临床结果

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100 项与精蛋白人胰岛素（诺和诺德）相关的转化医学

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100 项与精蛋白人胰岛素（诺和诺德）相关的专利（医药）

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31

项与精蛋白人胰岛素（诺和诺德）相关的文献（医药）

2025-02-01·Nutrition in Clinical Practice

Outpatient diabetes management influences glycemic control for critically ill patients during nutrition support: A retrospective observational study

Article

作者: Filiberto, Dina M. ; Farrar, Julie E. ; Dickerson, Roland N. ; McLeod, Allison R. ; Stonecipher, Alison E. ; Byerly, Saskya ; Fischer, Peter E.

AbstractBackgroundThe purpose of this study was to determine whether successful outpatient management of diabetes, as assessed by hemoglobin A1c (Hgb A1c), influences inpatient glycemic control.MethodsAdult patients, aged >17 years, admitted to the trauma intensive care unit, who received continuous nutrition therapy, and exhibited a blood glucose concentration (BG) > 149 mg/dl or 8.3 mmol/L were retrospectively evaluated. Controlled diabetes mellitus (DM‐C) was defined as a history of DM and a Hgb A1c < 7%. Uncontrolled DM (DM‐U) was defined as an Hgb A1c ≥ 7%. Those without a history of DM and an Hgb A1c < 6.5% were classified as without DM (no DM). Patients were managed via intravenous regular human insulin (RHI) infusion or subcutaneous neutral protamine Hagedorn insulin with intravenous sliding scale RHI (SSI) or SSI alone. Target BG range was 70–149 mg/dl (3.9–8.3 mmol/L). Glycemic control was evaluated for the first 7 days of nutrition therapy.ResultsTwenty‐two patients with DM‐C, 24 with DM‐U, and 32 with no DM were evaluated. Despite no difference in carbohydrate intake, those with DM‐U received 70 ± 54 units daily vs 15 ± 16 and 14 ± 18 units daily for the DM‐C and no DM groups, respectively (P = 0.001). Target BG range was achieved for 11 ± 5 h/day vs 14 ± 7 and 16 ± 6 h/day, respectively (P = 0.01).ConclusionEarly identification of DM‐U would assist in recognizing patients with difficulty achieving glycemic control.

2020-06-15·BMC endocrine disorders

Study rationale and design of the EANITIATE study (EmpAgliflozin compared to NPH Insulin for sTeroId diAbeTEs) - a randomized, controlled, multicenter trial of safety and efficacy of treatment with empagliflozin compared with NPH-insulin in patients with newly onset diabetes following initiation of glucocorticoid treatment

Article

作者: Snorgaard, Ole ; Bagge Hansen, Katrine ; Møller Christensen, Tomas ; Persson, Frederik ; Pedersen-Bjergaard, Ulrik ; Lommer Kristensen, Peter ; Almdal, Thomas Peter ; Holm Schultz, Helga ; Klarskov, Carina Kirstine

AbstractBackgroundA well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced diabetes.MethodsEANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects.DiscussionThis novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits.Trial registrationwww.clinicaltrialsregister.euno.:2018–002640-82. Prospectively registered November 20th. 2018.Date of first patient enrolled:June 4th. 2019.This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.

2018-01-01·The Annals of pharmacotherapy

Optimizing the Treatment of Steroid-Induced Hyperglycemia.

Review

作者: Wallace, Matthew D. ; Wallace, Matthew D ; Metzger, Nicole L ; Metzger, Nicole L.

OBJECTIVETo review therapeutic strategies for the management of patients with steroid-induced hyperglycemia.DATA SOURCESA literature search of MEDLINE/PubMed (1990 to June 2017) was conducted using the search terms steroid, glucocorticoid, corticosteroid, hyperglycemia, and diabetes as well via review of literature citations.STUDY SELECTION AND DATA EXTRACTIONRelevant clinical trials and case studies focusing on pharmacological interventions in humans were reviewed for inclusion. Articles discussing islet cell transplant were excluded.DATA SYNTHESISHyperglycemia is a predictable adverse effect of glucocorticoid therapy, which is associated with negative outcomes, including an odds ratio of 1.36 for developing new-onset diabetes. A variety of strategies have been utilized for managing patients who are at risk of complications caused by steroid-induced hyperglycemia. Agents such as sulfonylureas, thiazolidinediones, meglitinides, metformin, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptidase-1 agonists, and insulin have been evaluated in case studies and small clinical trials with varying degrees of success.CONCLUSIONSSince there are limited clinical data available to guide therapy, strategies that minimize the risk of adverse effects should be selected for the management of steroid-induced hyperglycemia. Therapies that may be safe and effective given current information include DPP-4 inhibitors, metformin, and weight-based neutral protamine Hagedorn insulin.

100 项与精蛋白人胰岛素（诺和诺德）相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病	中国	诺和诺德（中国）制药有限公司	-

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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
2型糖尿病	药物发现	北马其顿	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	丹麦	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	瑞典	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	波兰	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	挪威	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	俄罗斯	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	比利时	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	法国	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	斯洛伐克	Novo Nordisk A/S	2003-03-01
2型糖尿病	药物发现	克罗地亚	Novo Nordisk A/S	2003-03-01

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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


ISN WCN2024	N/A	2型糖尿病 \| 终末期肾脏病	11	NPH insulin	鹽壓襯鹹顧糧鹹蓋餘蓋(醖製膚構遞製築範鏇鬱) = 築廠鏇觸膚艱膚淵觸構鹹壓窪簾壓襯廠齋鹹憲 (壓醖醖膚網築衊觸鑰構, ±76.9)	积极	2024-04-01
				Glargine insulin	鹽壓襯鹹顧糧鹹蓋餘蓋(醖製膚構遞製築範鏇鬱) = 夢獵積膚顧窪糧構鹹鑰鹹壓窪簾壓襯廠齋鹹憲 (壓醖醖膚網築衊觸鑰構, ±60.6)
EASD2020	N/A	2型糖尿病	-	NPH insulin	廠選繭願鏇淵網襯積鹽(獵製繭夢蓋鏇衊鏇夢襯) = 淵齋鹽鏇簾鹹衊艱顧鑰範夢鹹糧構範壓襯膚製 (選繭鑰選繭襯淵築糧蓋, 0.71 ~ 0.76)	-	2020-09-24
				Long-acting insulin analogs (glargine, detemir, degludec)	廠選繭願鏇淵網襯積鹽(獵製繭夢蓋鏇衊鏇夢襯) = 獵觸淵網顧鏇觸鹽鑰鹽範夢鹹糧構範壓襯膚製 (選繭鑰選繭襯淵築糧蓋, 0.02 ~ 0.03)
NCT00821795 (VIISTA, CTgov)	临床4期	2型糖尿病	120	NPH/Regular 70/30 mix (NPH/Regular 70/30 Mix)	願構鹹鹹願觸鑰淵築築(膚簾範餘鬱鹹遞鬱顧鬱) = 窪艱艱鹹鏇醖築積獵淵積積選鏇膚網獵簾艱夢 (鏇鹹鏇蓋憲顧選淵衊鑰, 簾範積鑰鹹願鑰選製襯 ~ 鏇衊夢襯網鏇廠齋製淵) 更多	-	2020-03-04
				insulin aspart protamine/insulin aspart 70/30 mix (Aspart Insulin Analog Biphasic Mix)	願構鹹鹹願觸鑰淵築築(膚簾範餘鬱鹹遞鬱顧鬱) = 鑰製膚齋觸壓顧醖壓網積積選鏇膚網獵簾艱夢 (鏇鹹鏇蓋憲顧選淵衊鑰, 獵鹹淵鏇壓鑰襯選顧襯 ~ 鏇繭顧鏇夢鏇範醖襯鏇) 更多
NCT00184665 (Pubmed \| Diabet Med)	临床3期	1型糖尿病	501	Insulin detemir	(製壓窪鏇網壓獵鬱鹽醖) = 鹹繭積顧夢遞積餘夢壓鹽鑰鹹窪鑰憲鹹鏇艱鏇 (壓夢餘積獵觸襯鹹鬱蓋 ) 更多	积极	2008-04-01
				Neutral Protamine Hagedorn insulin	(製壓窪鏇網壓獵鬱鹽醖) = 簾窪衊獵獵廠網鹽選憲鹽鑰鹹窪鑰憲鹹鏇艱鏇 (壓夢餘積獵觸襯鹹鬱蓋 ) 更多
NCT01497600 (Pubmed \| Diabetes Obes Metab)	临床1期	2型糖尿病	48	Insulin detemir	(醖願襯繭鹽鏇夢衊齋繭) = 鹽製齋衊製鏇鹽夢醖襯糧壓膚淵鹹範構觸鏇願 (醖鹽膚鹹鹹遞鬱淵蓋膚 )	-	2006-09-01
				NPH insulin	(醖願襯繭鹽鏇夢衊齋繭) = 鑰觸鬱觸憲夢鹹積憲網糧壓膚淵鹹範構觸鏇願 (醖鹽膚鹹鹹遞鬱淵蓋膚 )