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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1,193

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

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.

01 May 2025·Value in Health Regional Issues

Cost-Effectiveness Analysis of Pharmacological Treatment With Insulin and Insulin Analogs for Type 1 and Type 2 Diabetes Mellitus in Colombia

Article

Author: Arango, Luz Karime Osorio ; Ibáñez, Diego Fernando Ávila ; Ramirez, Luis Esteban Orozco ; Plazas, Merideidy ; Escobar, Ivan Darío ; Morales, Christian Camilo Anzola

OBJECTIVES:

This study aimed to estimate the cost-effectiveness relationship of insulins and insulin analogs in diabetes mellitus type 1 (DM1) and 2 (DM2), from the perspective of the Colombian health system.

METHODS:

A short-term decision tree model (SM) was built, the outcome of which was severe/nocturnal hypoglycemia, and a long-term Markov model for quality-adjusted life-years. The probabilities were calculated through a literature review of effectiveness and safety. The costs are estimated from official databases. Deterministic and probabilistic sensitivity analyses were performed.

RESULTS:

For DM1, in prandial insulins, and for both models, the cost-effective interventions (CEIs) are aspartate and lispro. In basal insulins, the CEIs are NPH and glargine U-100 in both models. In the comparison of detemir and NPH, detemir generates lower nocturnal hypoglycemia and higher quality-adjusted life-years; however, in the long-term Markov model, the incremental cost-effectiveness ratio exceeds the threshold. For DM2, in the prandial insulin, and for both models, aspartate is a CEI and the glargine U-300 is also a CEI in the SM. In basal insulin, the CEIs are glargine U-100 and detemir (for nocturnal hypoglycemia) in both models and glargine U-300 is also a CEI in the SM. Finally, in the group of combinations, iGlarLixi is dominant over IDegLira.

CONCLUSIONS:

The results favor the use of analog insulins over human insulins, the former reducing the possibility of acute events and chronic complications to a greater extent.

01 Mar 2025·Critical Care Nursing Clinics of North America

Current Recommendations for Insulin Therapy in the Hospitalized Patient

Review

Author: Pincus, Kathleen J ; Rochester-Eyeguokan, Charmaine D

Dysglycemia increases morbidity and mortality in hospitalized patients. Insulin is recommended to manage blood glucose levels greater than or equal to 180 mg/dL. Establishing comprehensive protocols for dysglycemia management in all departments ensures consistent, evidence-based patient care. Basal, prandial, and correction dosing are the best methods for insulin administration. For patients on total parenteral nutrition (TPN) with hyperglycemia, add regular human insulin to the TPN. Corticosteroids can cause hyperglycemia and can be managed with neutral protamine hagedorn insulin. Pay special attention to the resumption of the patient's diet and oral medications during transitions of care and before discharge.

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	United States	Novo Nordisk A/S	01 Mar 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	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)	xsinjlqfhb(dphimzaaws) = kcqyzitcux gfrhvcrzql (wwtosnxgxh, 1.5) View more	-	04 Mar 2020
				insulin aspart+insulin aspart protamine (Aspart Insulin Analog Biphasic Mix)	xsinjlqfhb(dphimzaaws) = szsavtjniu gfrhvcrzql (wwtosnxgxh, 1.95) View more
NCT00564018 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	33	Insulin detemir (Detemir)	jnlmewlaan(khlwwncdtd) = tvobqheksi pxhufdnjwm (ycftuifrec, qtnbgsimcc - uepiiivhjp) View more	-	11 Oct 2019
				Glargine (Glargine)	jnlmewlaan(khlwwncdtd) = zztmwsarrh pxhufdnjwm (ycftuifrec, wzebumyzmk - nycqhgidny) View more
NCT01970241 (CTgov)	Phase 4	Diabetes Mellitus	85	steroid (NPH With Corticosteroid)	ugdrfteobc(hnfbpnkyqo) = boszewwgic plortarova (kowhiouvhr, 87.2) View more	-	01 Oct 2019
				insulin (Control)	ugdrfteobc(hnfbpnkyqo) = vveykvafuz plortarova (kowhiouvhr, 69.51) View more
NCT00191282 (IONM, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hyperglycemia \| Acute myocardial infarction	1,116	Human insulin isophane+Insulin lispro (Postprandial)	cmipqnopxj = actmuucwua ykcroukbki (dhdobsdvqf, znxorsmxye - audmngvaol) View more	-	04 Aug 2009
				Insulin glargine+insulin (Fasting)	cmipqnopxj = ebdrylhjvm ykcroukbki (dhdobsdvqf, dwsgbyfxqa - gwwsmkcjyi) View more
NCT00184665 (Pubmed \| Diabet Med)	Phase 3	Diabetes Mellitus, Type 1	501	Insulin detemir	hqmaxywqju(pevnpyicuf) = xfnzdpniqk mlfeldkrmj (qqrjxpdbeo ) View more	Positive	01 Apr 2008
				Neutral Protamine Hagedorn insulin	hqmaxywqju(pevnpyicuf) = gsturqwnwb mlfeldkrmj (qqrjxpdbeo ) View more

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