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A Randomized, Double Blind, Single Center, Two Treatment, Two-Period, TwoSequence, Crossover, Euglycemic clamp study to demonstrate equivalence in thePharmacokinetic and Pharmacodynamic properties of Insulin Aspart Mix 30 ofBioGenomics Limited and NovoMix® 30 of Novo Nordisk in healthy, adult, humanmale subjects under fasting condition.

Start Date14 Jun 2022

Sponsor / Collaborator

Biogenomics Ltd.

NCT03862690

/ WithdrawnNot Applicable

A Prospective Non-interventional Study Investigating the Treatment Effect of NovoMix® 30 (Biphasic Insulin Aspart 30) in a Real World Adult Population With Type 2 Diabetes in Algeria

The purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their study doctor's appointment.

Start Date28 May 2020

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Insulin aspart/insulin protamine aspart(Novo Nordisk)

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100 Translational Medicine associated with Insulin aspart/insulin protamine aspart(Novo Nordisk)

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100 Patents (Medical) associated with Insulin aspart/insulin protamine aspart(Novo Nordisk)

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87

Literatures (Medical) associated with Insulin aspart/insulin protamine aspart(Novo Nordisk)

01 Dec 2023·Internal Medicine Journal

Mixed insulin can improve control of prednisolone‐induced hyperglycaemia

Article

Author: Bach, Leon A ; Sztal-Mazer, Shoshana ; Scholes, Gemma ; Ng, Elisabeth

AbstractBackgroundHyperglycaemia is a common side effect of prednisolone, although there are no widely accepted guidelines for the management of glucocorticoid‐induced hyperglycaemia (GIH). Our institution uses mixed insulin in a pre‐breakfast or pre‐breakfast and pre‐lunch regimen, with the rationale that this profile of insulin action matches the physiological effect of prednisolone on blood glucose levels (BGLs).AimEvaluate the use of the mixed insulin (NovoMix30) in a pre‐breakfast or pre‐breakfast and pre‐lunch regimen as management for GIH in a tertiary hospital setting.MethodWe retrospectively evaluated all inpatients coprescribed prednisolone ≥7.5 mg and NovoMix30 for at least 48 hours over a 19‐month period. BGLs were evaluated with repeated‐measures analysis within four time periods across the day, beginning from the day prior to NovoMix30 administration.ResultsA total of 53 patients were identified. NovoMix30 significantly reduced BGLs in the morning (mean 12.7 ± 4.5 vs. 9.2 ± 3.9 mmol/L, P < 0.001), afternoon (mean 13.6 ± 3.8 vs. 11.9 ± 3.8 mmol/L, P = 0.001) and evening (12.1 ± 3.8 vs. 10.8 ± 3.8 mmol/L, P = 0.01). With uptitration of insulin over 3 days, 43% of all BGLs were within the target range, compared with 23% on day 0 (P < 0.001). The final median dose of NovoMix30 was 0.15 (0.10–0.22) units/kg bodyweight, or 0.40 (0.23–0.69) units/mg of prednisolone, which is lower than our hospital guideline recommends. One overnight hypoglycaemic event was observed.ConclusionMixed insulin as a pre‐breakfast or pre‐breakfast and pre‐lunch regimen can target the hyperglycaemic pattern induced by prednisolone and minimise overnight hypoglycaemia. However, higher doses of insulin than those used in our study are likely required for optimal BGL control.

01 Mar 2023·Diabetes, Obesity and Metabolism

Findings for iGlarLixi versus BIAsp 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics

Article

Author: Melas‐Melt, Lydie ; Blüher, Matthias ; Pegelow, Katrin ; Giorgino, Francesco ; Home, Philip D. ; Djaballah, Khier ; McCrimmon, Rory J. ; Rosenstock, Julio

AbstractAimTo report prespecified and post hoc analyses of the SoliMix dataset exploring the impact of baseline participant characteristics on the original SoliMix study outcomes, to enable informed treatment choices for people with different biomedical characteristics.MethodsSoliMix (EudraCT 2017‐003370‐13) compared once‐daily iGlarLixi (a fixed‐ratio combination of insulin glargine 100 U/mL and the glucagon‐like peptide‐1 receptor agonist lixisenatide) with twice‐daily BIAsp 30 (30% insulin aspart and 70% insulin aspart protamine). In this analysis, the original primary outcomes of noninferiority of iGlarLixi versus BIAsp 30 in terms of glycated haemoglobin (HbA1c) change and superiority in terms of body weight change, together with change in basal insulin dose and hypoglycaemia outcomes, were investigated by baseline age, duration of diabetes, insulin dose, HbA1c level, body mass index (BMI), and renal function.ResultsNo evidence of difference in comparative treatment effect was detected across baseline age, duration of diabetes, insulin dose, HbA1c level, BMI and renal function subgroups for any endpoint (all heterogeneity P > 0.05), except American Diabetes Association Level 2 hypoglycaemia event rate when stratified by insulin dose (P = 0.011), which may be a chance difference given multiple testing and the small numbers of Level 2 events.ConclusionsTreatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes and renal function, supporting the use of iGlarLixi as an efficacious and well‐tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics.

31 Jan 2023·Diabetes & Metabolism Journal

Performance of Fast-Acting Aspart Insulin as Compared to Aspart Insulin in Insulin Pump for Managing Type 1 Diabetes Mellitus: A Meta-Analysis

Article

Author: Mahajan, Kunal ; Dutta, Deep ; Sharma, Meha ; Mohindra, Ritin

Background: No meta-analysis has analysed efficacy and safety of fast-acting aspart insulin (FIAsp) with insulin pump in type 1 diabetes mellitus (T1DM).Methods: Electronic databases were searched for randomised controlled trials (RCTs) involving T1DM patients on insulin pump receiving FIAsp in intervention arm, and placebo/active comparator insulin in control arm. Primary outcome was to evaluate changes in 1- and 2-hour post-prandial glucose (1hPPG and 2hPPG). Secondary outcomes were to evaluate alterations in percentage time with blood glucose <3.9 mmol/L (hypoglycaemia), time in range (TIR) blood glucose 3.9 to 10 mmol/L, insulin requirements and adverse events.Results: Data from four RCTs involving 640 patients was analysed. FIAsp use in insulin pump was associated with significantly greater lowering of 1hPPG (mean difference [MD], –1.35 mmol/L; 95% confidence interval [CI], –1.72 to –0.98; P<0.01; I2=63%) and 2hPPG (MD, –1.19 mmol/L; 95% CI, –1.38 to –1.00; P<0.01; I2=0%) as compared to controls. TIR was comparable among groups (MD, 1.06%; 95% CI, –3.84 to 5.96; P=0.67; I2=70%). Duration of blood glucose <3.9 mmol/L was lower in FIAsp group, approaching significance (MD, –0.91%; 95% CI, –1.84 to 0.03; P=0.06; I2=0%). Total hypoglycaemic episodes (risk ratio [RR], 1.35; 95% CI, 0.55 to 3.31; P=0.51; I2=0%), severe hypoglycaemia (RR, 2.26; 95% CI, 0.77 to 6.66; P=0.14), infusion site reactions (RR, 1.35; 95% CI, 0.63 to 2.93; P=0.77; I2=0%), and treatment-emergent adverse events (RR, 1.13; 95% CI, 0.80 to 1.60; P=0.50; I2=0%) were comparable.Conclusion: FIAsp use in insulin pump is associated with better post-prandial glycaemic control with no increased hypoglycaemia or glycaemic variability.

6

News (Medical) associated with Insulin aspart/insulin protamine aspart(Novo Nordisk)

31 Aug 2024

·www.drugs.com

Everything You Need to Know About Insulin

SATURDAY, Aug. 31, 2024 -- Insulin can be a critical part of managing diabetes, but patients may not know all of the ins and outs of using the medication effectively. Luckily, the American Diabetes Association (ADA) has plenty of information and tips on using insulin. First, there are different types of insulin, depending on how fast they work, when they peak and how long they last. Insulin is also available in varying strengths and all insulin made in the United States is produced in a lab, the ADA noted. Whether someone needs to take insulin, and how much, varies by patient and the type of diabetes a patient has. In people with type 1 diabetes, the pancreas no longer makes insulin at all. The beta cells have been destroyed, and these patients need insulin shots. With type 2 diabetes, people make insulin but their bodies don't respond well to it. Some people with type 2 diabetes need insulin. Why does insulin have to be given as shots? If taken in pill form, it would be broken down during digestion, so it must be injected into the fat under your skin. In rare cases, insulin can trigger an allergic reaction at the injection site. Talk to your doctor if you believe you are experiencing a reaction, the ADA advised. Depending on a patient's needs, there are several types of insulin available: Premixed insulin can be helpful for those who have poor eyesight or dexterity and it's convenient for people whose diabetes has been stabilized, the ADA added. In 2015, an inhaled insulin product called Afrezza became available in the United States. Afrezza acts rapidly at the beginning of each meal and can be used by adults with type 1 or type 2 diabetes. However, it is not a substitute for long-acting insulin, the ADA noted. Afrezza must be used in combination with injectable long-acting insulin in patients with type 1 diabetes and in type 2 patients who use long-acting insulin. It begins working within 12 to 15 minutes, peaks by 30 minutes, and is out of your system in 180 minutes. Apart from differences in how quickly insulin acts and how long it lasts, there are different strengths of the medication, the ADA noted. The most commonly used strength in the United States is U-100, which means it has 100 units of insulin per milliliter of fluid, though U-500 insulin is available for patients who are extremely insulin-resistant. If you're traveling outside of the United States, be certain to match your insulin strength with the correct size syringe. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

15 Mar 2023

·www.pharmaceutical-technology.com

Novo Nordisk to reduce US list prices of insulin products

Novo Nordisk has various long-standing US affordability offerings for eligible people living with diabetes. Credit: Novo Nordisk A/S. Novo Nordisk has announced plans to reduce the US wholesale acquisition cost (WAC), also known as the list price, of several pre-filled insulin pens and vials by up to 75% for people living with type 1 and type 2 diabetes. Set to come into effect from 1 January 2024, these changes will be applicable for products including pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, Levemir, Novolin, NovoLog and NovoLog Mix 70/30 in specific. Novo Nordisk Market Access & Public Affairs senior vice-president Steve Albers said: “We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes. “Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.” The company will reduce the list price of four legacy insulin brands, including NovoLog and NovoLog Mix 70/30 by 75%, and Novolin and Levemir by 65% off the current list price. Additionally, the list price of unbranded biologics (pre-filled pens and vials and pre-mix insulins) is being reduced to match the lowered price of each respective branded insulin (Insulin Aspart and Insulin Aspart Protamine/Insulin Aspart). Novo Nordisk also has various long-standing US affordability offerings for eligible people who are living with diabetes. They include Unbranded Biologics, the Novo Nordisk Human Insulin programme, Co-pay Savings Cards, My$99Insulin, Immediate Supply, A Patient Assistance Program (PAP) and the Covid-19 Patient Assistance Program. Working with a diverse group of stakeholders, Novo Nordisk said it will understand the emerging needs of patients.

14 Mar 2023

·medcitynews.com

Novo Nordisk Follows Eli Lilly’s Lead, Lowering Insulin Prices up to 75%

Novo Nordisk is slashing prices of several insulin products by up to 75% amid growing political scrutiny on the prices of these older but still expensive diabetes medicines. The announcement Tuesday comes two weeks after rival Eli Lilly unveiled price cuts for its insulin products, but unlike Lilly’s new pricing, which will start this spring for some products, Novo Nordisk’s new insulin prices won’t take effect until 2024. The Novo Nordisk products covered under the new list prices include the long-acting insulins Levemir and Novolin, which will see 65% price cuts. Levemir will cost $107.85 per vial and $161.77 for product dosed with the FlexPen delivery system. Novolin will cost $48.20 per vial and $91.09 per FlexPen. The fast-acting insulin products Novolog and Novolog Mix 70/30 will see 75% price cuts to $72.34 per vial, $139.71 per FlexPen. Denmark-based Novo Nordisk, which maintains a U.S. headquarters in Plainsboro, New Jersey, also said it will reduce the list price for unbranded biologics to match the lower price of the corresponding branded insulin. Unbranded biologics are the branded product marketed under a different name. The lower prices cover Insulin Aspart, which is the unbranded biologic of Novolog, and Insulin Aspart Protamine/Insulin Aspart, which is unbranded Novolog Mix 70/30. Novo Nordisk can afford to cut insulin prices because it is seeing rapid growth from other products. While the company’s insulins are blockbuster sellers, their sales growth has flattened. The company reported 38.7 billion Danish krone (about $5.6 billion) in 2022 revenue for all of its insulin products, down nearly 3% from the prior year and just 1% higher compared to two years ago. Meanwhile, the drugmaker is seeing strong sales growth from diabetes and obesity medications in its semaglutide franchise. Ozempic, a type 2 diabetes drug that works by activating the GLP-1 receptor, is far and away Novo Nordisk’s largest single product with 17.3 billion Danish krone (about $2.5 billion) in 2022 sales, up more than 96% from the prior year. Rybelsus, a GLP-1-targeting drug that like Ozempic, contains semaglutide but in an oral formulation, posted 3.1 billion Danish krone (about $455 million) in sales last year, a more than 500% increase over 2021 sales. In January, the FDA expanded Rybelsus’s approval to include first-line treatment of type 2 diabetes. Permitting the drug for use as an earlier treatment further expands the market for the product. Novo Nordisk is seeing strong demand for the semaglutide-containing weight-loss drug Wegovy, which won its FDA approval in mid-2021. Demand for Wegovy and Ozempic for use in treating obesity has strained the company’s manufacturing capacity, leading to shortages. The insulin market is dominated by three companies: Eli Lilly, Novo Nordisk, and Sanofi. Since Eli Lilly’s announcement at the beginning of March that it would cut list prices for its insulin products by up to 70%, some lawmakers have been calling on Novo Nordisk and Sanofi to do the same. A $35 per month price cap on insulin went into effect at the beginning of this year, but only for Medicare beneficiaries. That price cap was one of the provisions of the wide-ranging Inflation Reduction Act. Lilly’s pricing announcement extended the monthly cap to all insured diabetes patients who take the pharmaceutical company’s insulins. Those who aren’t covered by health insurance may enroll in a program that makes all of Lilly’s insulins available for $35 a month. Novo Nordisk said that it currently offers co-pay savings cards for patients covered by commercial insurance plans. These cards enable eligible patients to pay monthly co-pays of $25 to $35 for several of the company’s insulin products. In its announcement, Novo Nordisk said it has been working to identify “a sustainable approach to reduce insulin costs for patients that addresses changes in health policy and market shifts.” “We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes,” Steve Albers, Novo Nordisk’s senior vice president of market Access and public affairs, said in a prepared statement. “Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.” Photo by Jean-Francois Monier/AFP, via Getty Images

Drug Approval

100 Deals associated with Insulin aspart/insulin protamine aspart(Novo Nordisk)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	US	Novo Nordisk, Inc.	01 Nov 2001

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 1	DE	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 1	Phase 1	AT	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 1	Phase 1	CH	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 1	Phase 1	IE	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 1	Phase 1	GB	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 2	Preclinical	DE	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 2	Preclinical	CH	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 2	Preclinical	AT	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 2	Preclinical	GB	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Type 2	Preclinical	IE	Novo Nordisk A/S	01 Apr 1998

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Clinical Result

Indication

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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)	pzcfuoaxou(qoktxywqdl) = kkczvfysbk nimlxzunsu (nffhboltqm, igumycurbz - tqkeqvdxis) View more	-	04 Mar 2020
				insulin aspart protamine/insulin aspart 70/30 mix (Aspart Insulin Analog Biphasic Mix)	pzcfuoaxou(qoktxywqdl) = xtusdndbke nimlxzunsu (nffhboltqm, ugrkhftdvp - ebtvzohirp) View more
NCT02453685 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	335	Insulin+metformin+BIAsp 30 (BIAsp 30)	(ddrtbjujwu) = efzaqesexw cwnimygnux (vtyrjlwmpk, ilqkuejlih - bnyylcsbdk) View more	-	08 Feb 2019
				Insulin+metformin (Basal-bolus)	(ddrtbjujwu) = pgucevyisb cwnimygnux (vtyrjlwmpk, ytjlegdlqz - vhhuzvccrq) View more
NCT01059812 \| NCT01009580 (BOOST INTENSIFY PREMIX I (NCT01009580) and BOOST INTENSIFY ALL (NCT01059812), Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp	(agyhzjwpib) = similar for IDegAsp versus BIAsp 30 rhffuxgnws (okcxvypmrk ) View more	-	01 Feb 2019
				BIAsp 30
NCT01589653 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	155	biphasic insulin aspart 30 (Subject-driven Titration)	tirqttmcke(nevluvfucr) = hxshgmxuil bqtzdrdvnz (qxbordplfc, qwporvwimp - gidhsxepig) View more	-	09 Aug 2016
				biphasic insulin aspart 30 (Investigator-driven Titration)	tirqttmcke(nevluvfucr) = cdmxosikyk bqtzdrdvnz (qxbordplfc, nuagzrgwou - sjxvsdzsgk) View more
NCT01009580 (BOOST™, CTgov)	Phase 3	Diabetes Mellitus, Type 2	447	insulin degludec/insulin aspart (IDegAsp BID)	(abqpgkdkks) = fbbunzcbdw izgpfbngay (cxofoqedrf, qbrvdsaixy - uphiaavptz) View more	-	20 Nov 2015
				biphasic insulin aspart 30 (BIAsp 30 BID)	(abqpgkdkks) = yrcffhedqe izgpfbngay (cxofoqedrf, ojojhqknfo - afjiilvscf) View more
EASD2015	Not Applicable	Diabetes Mellitus, Type 2	-	Premixed insulin	(cuiomkajfp) = aempcxgjrg jldtwllqew (mjidxvyhcf )	Positive	17 Sep 2015
				Bolus insulin	(cuiomkajfp) = gyzadksref jldtwllqew (mjidxvyhcf )
NCT01618214 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	344	biphasic insulin aspart 30 (Subject-driven Titration)	phwetrplwm(ebhfjbpsnf) = lfpdambwby ckluelzilg (krdhpmndhf, uwspfqjkwo - clhrtyicat) View more	-	08 May 2014
				biphasic insulin aspart 30 (Investigator-driven Titration)	phwetrplwm(ebhfjbpsnf) = irejukdtww ckluelzilg (krdhpmndhf, jfmedcugbu - epkhiogdmb) View more
NCT01215435 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	245	biphasic insulin aspart 30 (Pre-breakfast BIAsp 30)	pwcemvkaka(lrooytqkvk) = oarfugqqps toesmrvujc (qhtjltbvjt, avhtbklkjp - ysvygecbse) View more	-	25 Nov 2013
				biphasic insulin aspart 30 (Pre-dinner BIAsp 30)	pwcemvkaka(lrooytqkvk) = qhbzjhdoyy toesmrvujc (qhtjltbvjt, qskvhutrrc - mscyicprbd) View more
NCT01059812 \| NCT01009580 (EASD2013)	Phase 3	Diabetes Mellitus, Type 2 Maintenance	-	IDegAsp	(mzsafxixgb) = dazzpewezm qyrfmiicpq (bmfpqtyadl ) View more	Positive	26 Sep 2013
				BIAsp 30	-
NCT01009580 (EASD2013)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp	(isiyuroicz) = yjwflssyzy ekhsgmgmae (vveczcoohs ) View more	Positive	26 Sep 2013
				BIAsp 30	(isiyuroicz) = pdcerowxxu ekhsgmgmae (vveczcoohs ) View more