Delving into the Latest Updates on Isophane Protamine Human Insulin(Novo Nordisk A/S) with Synapse

Overview

Basic Info

Drug Type

Recombinant protein

Synonyms

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

+ [1]

Target

INSR

Action

agonists

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus

Inactive Indication

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Hypoglycemia+ [1]

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk China Pharmaceuticals Co. Ltd.

Inactive Organization

Novo Nordisk A/S

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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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.

Start Date01 Apr 2024

Sponsor / Collaborator

Loyola University Medical Center

NCT01970241

/ CompletedPhase 4IIT

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.

Start Date01 Jul 2014

Sponsor / Collaborator

Hennepin Healthcare Research Institute

[+1]

NCT00821795

/ CompletedPhase 4

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.

Start Date11 Mar 2009

Sponsor / Collaborator

Lexington Va Medical Center

[+1]

100 Clinical Results associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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100 Translational Medicine associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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100 Patents (Medical) associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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1,086

Literatures (Medical) associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

01 Dec 2025·CANADIAN JOURNAL OF PHYSIOLOGY AND PHARMACOLOGY

Insulin modulates MMP-2 and 9 activities through the control of oxidative stress in the heart of diabetic rats

Article

Author: da Silva, Thayane Christine Alves ; Souza, Marcus Vinicius ; Lima, Wanderson Geraldo ; Paula-Gomes, Sílvia ; Martins, Bruno Teixeira ; Gutierres, Vitor Valadares ; de Deus, Isabela Jesus ; Fagundes, Miliane Martins de Andrade ; das Mercês, Aline Coelho ; Ceron, Carla Speroni

This study aimed to evaluate the effects of insulin therapy on oxidative stress markers, matrix metalloproteinases (MMPs) 2 and 9 activities, and cardiac remodeling in alloxan-induced diabetic rats. Forty-two male Wistar rats were randomly allocated into three groups ( n ≤ 14 animals), for 30 days: control (CON; saline, IP); diabetes mellitus (DM; alloxan 60 mg/kg, IP); and insulin-treated diabetic (DINS; NPH insulin 4 U, twice daily, IP). After the treatment, the animals were anesthetized and euthanized, and plasma and heart were collected for biochemical, histological, and enzymatic analysis. Compared to DM, the DINS exhibited improved body and heart masses, as well as reduced food intake. Insulin significantly decreased glycemia, triglycerides, and total cholesterol. The antioxidant defenses were enhanced (increased catalase activity and concentrations of reduced glutathione), while the oxidative damage was reduced (decreased protein carbonyls and thiobarbituric acid reactive substance concentrations). Histological analysis revealed a reduction in the inflammatory nuclei and collagen deposition. MMP-2 and MMP-9 activities were lower in the DINS compared to the DM. The insulin treatment attenuated oxidative stress, modulated MMP activity, and collagen accumulation in the heart of diabetic rats. These findings support the potential role of insulin in mitigating diabetes-induced cardiac remodeling through redox balance.

15 Oct 2025·Clinical diabetes : a publication of the American Diabetes Association

Regular Insulin Versus NPH Insulin for Continuous Enteral Tube Feeding in Hospitalized Patients

Author: Kalangi, Sreevastav Teja ; Bokka, Siddidha Mangasai ; Anand, Seerat ; Garg, Rajesh

There is no standard insulin regimen for treating hyperglycemia in patients receiving continuous enteral tube feeding (TF) in the hospital setting. This study compared the use of regular insulin versus NPH insulin for this purpose. Glucose levels were significantly lower in the regular insulin group than in the NPH insulin group, as were the number of days with hyperglycemia or severe hyperglycemia. There were also fewer insulin injections with regular insulin than with NPH insulin. Thus, use of regular insulin yielded better glycemic control than the use of NPH insulin for covering continuous TF.

01 Jun 2025·Exploratory research in clinical and social pharmacy

Impact of switching from neutral protamine hagedorn insulin (NPH) to glargine insulin on glycemic control and clinical outcomes in pediatric patients with type 1 diabetes

Article

Author: Karar, Mazen ; Khalid, Omar ; Abdullah, Omnia ; Kamal, Ahmed Hafiz ; Mamoun, Setana ; Badi, Safaa ; Fouad, Mohamed ; Elsheikh, Hiba Abdelmunim Suliman

Background:

Treatment of type 1 diabetes requires insulin therapy, and various types of insulin can be used. Insulin glargine has been shown to provide effective glycemic control with reduced hypoglycemia. However, there are no prior studies investigating the effects of switching from neutral protamine hagedorn (NPH) insulin to glargine insulin in Sudan, due to limited use of glargine insulin and funding constraints.

Objective:

This study aimed to assess the impact of switching from NPH insulin to glargine insulin on glycemic control in children with type 1 diabetes, and to identify factors precipitating the switch.

Methods:

This observational cross-sectional study included 221 children (aged 1-19 years) with type 1 diabetes who switched from NPH insulin to glargine insulin at Mohamed Alamin Hamid Pediatric Hospital. Simple random sampling was used to select participants.

Results:

Of the 221 participants, 83 (37.5 %) switched to glargine insulin, 60 (27.1 %) continued on NPH insulin, and 78 (32.5 %) started on glargine from the beginning. Switching to glargine insulin was associated with a statistically significant reduction in HbA1c (P < 0.001) and a significant decrease in fasting blood glucose (FBG) levels (P < 0.001). Additionally, 69.9 % of participants experienced an increase in their insulin dose (P < 0.001). The primary reason for switching, as reported by 57.8 % of caregivers, was that mixed insulin had not effectively controlled blood glucose, with 60.4 % of these participants experiencing hypoglycemia. Of those who switched, 94 % were satisfied, with 33.3 % reporting better blood sugar control and 89.7 % indicating improvements in general health. A significant increase in weight was observed after switching to insulin glargine (P = 0.0001).

Conclusion:

Switching from NPH to glargine insulin among Sudanese pediatric patients with type 1 diabetes offer significant benefits in glycemic control, as reflected by improved HbA1c and FBG levels. Additionally, insulin dose and weight increased, contributing to enhanced overall health and blood glucose management. Hypoglycemia was a major reason for switching.

100 Deals associated with Isophane Protamine Human Insulin(Novo Nordisk A/S)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	China	Novo Nordisk China Pharmaceuticals Co. Ltd.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	Spain	Novo Nordisk A/S	01 Apr 2005
Diabetes Mellitus, Type 1	Phase 3	Japan	Novo Nordisk A/S	01 Apr 2003
Diabetes Mellitus, Type 2	Phase 3	Belgium	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	Croatia	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	Denmark	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	France	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	North Macedonia	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	Norway	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	Poland	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Phase 3	Russia	Novo Nordisk A/S	01 Mar 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00821795 (VIISTA, CTgov)	Phase 4	Diabetes Mellitus, Type 2	120	NPH/Regular 70/30 mix (NPH/Regular 70/30 Mix)	utnyikcmse(rxchmbqigb) = ggwiqhdtis ruxxtuftki (lcnpyissna, 1.5) View more	-	04 Mar 2020
				insulin aspart+insulin aspart protamine (Aspart Insulin Analog Biphasic Mix)	utnyikcmse(rxchmbqigb) = jmxqjukomx ruxxtuftki (lcnpyissna, 1.95) View more
NCT00564018 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	33	Insulin detemir (Detemir)	rirdhsitlt(rwheyvurpm) = rdarbsshts vyrelfjtdh (tfffdxfsyv, cdziwozdrs - bthxdhozwx) View more	-	11 Oct 2019
				Glargine (Glargine)	rirdhsitlt(rwheyvurpm) = pqlgsklovo vyrelfjtdh (tfffdxfsyv, ejjjxtqsfj - fqeoizmiwv) View more
NCT01970241 (CTgov)	Phase 4	Diabetes Mellitus	85	steroid (NPH With Corticosteroid)	fmjdbgottl(viwvchjecf) = vuwsdrqesb nfwdtgbmih (tuxwzjwtcw, 87.2) View more	-	01 Oct 2019
				insulin (Control)	fmjdbgottl(viwvchjecf) = oveqwzktsf nfwdtgbmih (tuxwzjwtcw, 69.51) View more
Pubmed \| J Matern Fetal Neonatal Med	Phase 3	Diabetes Mellitus, Type 1	470	Insulin detemir	lrbzyqbrrd(gpnhjadlfz) = The incidence of adverse events was similar between treatments cbjpctxnhn (jvqgckduyi )	Positive	01 Jan 2014
				Neutral protamine Hagedorn
NCT00191282 (IONM, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hyperglycemia \| Acute myocardial infarction	1,116	Human insulin isophane+Insulin lispro (Postprandial)	ypbnimfbfr = ygfidrxdmz xhfieedmcp (agueodhmrj, wfclgvxlid - izzxpeybnc) View more	-	04 Aug 2009
				Insulin glargine+insulin (Fasting)	ypbnimfbfr = qebykkxiqa xhfieedmcp (agueodhmrj, xyezhsfywm - tbzbqzahlw) View more
PREDICTIVE (Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus, Type 2	51,170	NPH insulin	oqvtbtjcms(dkvichhsji) = ohvkcadfzw cewkuekiru (zlevzvijjd ) View more	-	01 Jan 2008
				insulin glargine	oqvtbtjcms(dkvichhsji) = lxlquegjic cewkuekiru (zlevzvijjd ) View more

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Biosimilar

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