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

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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31

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

01 Feb 2025·Nutrition in Clinical Practice

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

Article

Author: 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.

15 Jun 2020·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

Author: 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.

01 Jan 2018·The Annals of pharmacotherapy

Optimizing the Treatment of Steroid-Induced Hyperglycemia.

Review

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

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R&D Status

Approved

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

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Discovery	MK	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	DK	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	SE	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	PL	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	NO	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	RU	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	BE	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	FR	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	SK	Novo Nordisk A/S	01 Mar 2003
Diabetes Mellitus, Type 2	Discovery	HR	Novo Nordisk A/S	01 Mar 2003

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISN WCN2024	Not Applicable	Diabetes Mellitus, Type 2 \| Kidney Failure, Chronic	11	NPH insulin	ewjutcrubx(tyykhjxsou) = jftmlsvmqn rtdtkxlarg (vdszndzunj, ±76.9)	Positive	01 Apr 2024
				Glargine insulin	ewjutcrubx(tyykhjxsou) = axplkjmiyn rtdtkxlarg (vdszndzunj, ±60.6)
EASD2020	Not Applicable	Diabetes Mellitus, Type 2	-	NPH insulin	pwfzemztrb(zhfziwiflu) = ljsootxnfk tsmjxlskfb (qsyskqqtqy, 0.71 - 0.76)	-	24 Sep 2020
				Long-acting insulin analogs (glargine, detemir, degludec)	pwfzemztrb(zhfziwiflu) = zeniuwbfjp tsmjxlskfb (qsyskqqtqy, 0.02 - 0.03)
NCT00821795 (VIISTA, CTgov)	Phase 4	Diabetes Mellitus, Type 2	120	NPH/Regular 70/30 mix (NPH/Regular 70/30 Mix)	bjzrvqaofz(nvfjyxosxh) = tfeubzxdao ineezajdts (qnmhyapjmu, thhxgduuze - nkasaoeuki) View more	-	04 Mar 2020
				insulin aspart protamine/insulin aspart 70/30 mix (Aspart Insulin Analog Biphasic Mix)	bjzrvqaofz(nvfjyxosxh) = kncqqtqtzm ineezajdts (qnmhyapjmu, bjpgzferpo - wdetmhndlc) View more
NCT00184665 (Pubmed \| Diabet Med)	Phase 3	Diabetes Mellitus, Type 1	501	Insulin detemir	(wnnmkvedko) = cbxawnmweb hbrlynulyz (rdlkdqnqbu ) View more	Positive	01 Apr 2008
				Neutral Protamine Hagedorn insulin	(wnnmkvedko) = sitajlbntk hbrlynulyz (rdlkdqnqbu ) View more
NCT01497600 (Pubmed \| Diabetes Obes Metab)	Phase 1	Diabetes Mellitus, Type 2	48	Insulin detemir	(ixkqvlwzjd) = sdnrizqvdv fwyftubsxd (jcghcahdbg )	-	01 Sep 2006
				NPH insulin	(ixkqvlwzjd) = ppdxjmojjs fwyftubsxd (jcghcahdbg )