Delving into the Latest Updates on Insulin aspart/insulin protamine aspart(Novo Nordisk) with Synapse

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)

Login to view more data

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

Login to view more data

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

Login to view more data

83

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

Abstract:

Background:

Hyperglycaemia 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).

Aim:

Evaluate 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.

Method:

We 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.

Results:

A 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.

Conclusion:

Mixed 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 & metabolism

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

Article

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

Abstract:

Aim:

To 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.

Methods:

SoliMix (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.

Results:

No 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.

Conclusions:

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

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; <i>P<0.01; I<sup>2=63%) and 2hPPG (MD, –1.19 mmol/L; 95% CI, –1.38 to –1.00; P<0.01; I<sup>2=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; <i>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.

2

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

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

14 Mar 2023

·www.biospace.com

Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024

Novo Nordisk has been working to identify a sustainable approach to reduce insulin costs for patients that addresses changes in health policy and market shifts Lower list prices build on long-standing history of affordability initiatives already in place which can be accessed at NovoCare.com Novo Nordisk currently provides co-pay support for a number of insulin products meaning eligible patients can pay $25-35 for their insulin PLAINSBORO, N.J., March 14, 2023 /PRNewswire/ -- Novo Nordisk Inc. today announced it is lowering the U.S. list prices of several insulin products by up to 75% for people living with type 1 and type 2 diabetes. Products include both pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, specifically Levemir®, Novolin®, NovoLog® and NovoLog® Mix 70/30. Novo Nordisk is also reducing the list price of unbranded biologics to match the lowered price of each respective branded insulin. These changes will go into effect on January 1, 2024. Novo Nordisk recognizes that some patients find it difficult to pay for healthcare, including insulin. As such, the Company remains committed to reducing the burden of out-of-pocket costs, helping transform the complex pricing system, and fostering better pricing predictability. Novo Nordisk continually reviews and revises our offerings as well as works with diverse stakeholders to create solutions for differing patient needs. "We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes," said Steve Albers, senior vice president, Market Access & Public Affairs at Novo Nordisk, Inc. "Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously." The following changes to the wholesale acquisition cost (WAC), also known as the list price, will take effect on January 1, 2024: Lowering the list price of four legacy insulin brands, including NovoLog® and NovoLog® Mix 70/30 by 75% off the current list price, and Novolin® and Levemir® by 65% off the current list price. New prices of these products will be as follows: NovoLog® & NovoLog® Mix 70/30 Levemir® Novolin® Vial $72.34 $107.85 $48.20 FlexPen® $139.71 $161.77 $91.09 Reducing the list price of the following unbranded biologics (pre-filled pens and vials and pre-mix insulins) to match the lowered price of each respective branded insulin: Insulin Aspart and Insulin Aspart Protamine/Insulin Aspart. Additionally, Novo Nordisk has a variety of long-standing U.S. affordability offerings available to eligible people living with diabetes, including: Unbranded Biologics: Insulin Degludec is currently available at 65% off the list price of Tresiba®; Insulin Aspart and Insulin Aspart Protamine/Insulin Aspart are currently available at 50% off the list price of NovoLog® and NovoLog® Mix. Novo Nordisk Human Insulin: A program through Walmart for more than two decades offers human insulin for approximately $25 per vial; it is also available at CVS for $25. Co-pay Savings Cards: Co-pays for as little as $25-35 for several insulin products for eligible patients in commercial insurance plans. My$99Insulin: A 30-day supply of a combination of insulin products (up to three vials or two packs of pens) for $99, equating to $33/vial or $49.50/pack of pens. Immediate Supply: A one-time free 30-day supply of insulin (up to three vials or two packs of pens) to eligible patients at risk of rationing. A Patient Assistance Program (PAP): Offers free diabetes medication to people in need who meet certain eligibility criteria. COVID-19 Patient Assistance Program: Offers 90 days of free insulin to eligible patients who lost healthcare coverage due to COVID-19 job loss. Novo Nordisk will continue to work with a diverse group of stakeholders to understand emerging patient needs. People living with diabetes are encouraged to access and learn more about these affordability programs at NovoCare.com. Please visit mynovoinsulin.com for more important information about Novo Nordisk Inc. insulins. About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in seven states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, and Twitter. Company Codes: NYSE:NVO

Acquisition

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

Login to view more data

R&D Status

Approved

10 top approved records.

Login

to view more data

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

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	AT	Novo Nordisk A/S	30 Apr 1998
Diabetes Mellitus, Type 2	Phase 3	IE	Novo Nordisk A/S	30 Apr 1998
Diabetes Mellitus, Type 2	Phase 3	CH	Novo Nordisk A/S	30 Apr 1998
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	CN	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	AT	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	DE	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	IE	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	CH	Novo Nordisk A/S	01 Apr 1998
Diabetes Mellitus, Insulin-Dependent, 2	Phase 3	GB	Novo Nordisk A/S	01 Apr 1998
Diabetic Retinopathy	Phase 1	CN	The Third Affiliated Hospital, Sun Yat-Sen University	31 Jul 2015

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00821795 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	120	NPH/Regular 70/30 mix (NPH/Regular 70/30 Mix)	oflhmjvcrb(xttkmxmang) = gmhokmczte vcimveydmc (ubftexlymf, puogxuvqjf - qkllhyeiaj) View more	-	04 Mar 2020
				insulin aspart protamine/insulin aspart 70/30 mix (Aspart Insulin Analog Biphasic Mix)	oflhmjvcrb(xttkmxmang) = swdoujohtn vcimveydmc (ubftexlymf, gjgcmuopoy - fekveevwgj) View more
NCT01618214 (Pubmed \| J Diabetes Investig)	Phase 4	Diabetes Mellitus, Type 2	344	Subject-driven titration of BIAsp 30 BID	rqpssdvwxf(yfthzmptxu) = nrerlkhiac vcsgerppzj (ggbuiqqcbm )	Positive	01 Jan 2016
				Investigator-driven titration of BIAsp 30 BID	rqpssdvwxf(yfthzmptxu) = cxbzcxaecy vcsgerppzj (ggbuiqqcbm )
NCT00869908 (Pubmed \| J Med Econ)	Not Applicable	Diabetes Mellitus, Type 2	66,726	Biphasic human insulin 30 (BHI)	ygmzvzmleq(mazuiacrwe) = kbdjuzglin lgdlfhrkym (jqxepvyfql )	-	01 Apr 2015
				Insulin glargine (IGlar)	ygmzvzmleq(mazuiacrwe) = tvfipxhaij lgdlfhrkym (jqxepvyfql )
NCT01427920 (SimpleMix, Pubmed \| Curr Med Res Opin)	Phase 4	Diabetes Mellitus, Type 2	348	Patient-driven BIAsp 30 titration	sqhbeimmwr(hgcwuzcpzt) = xqitlxgoua ztolezeecr (swiyywwuvn ) View more	Negative	01 Dec 2014
				Investigator-driven BIAsp 30 titration	sqhbeimmwr(hgcwuzcpzt) = dvcbtrhiaj ztolezeecr (swiyywwuvn ) View more
NCT00869908 (A1chieve®, Pubmed \| Health Qual Life Outcomes)	Not Applicable	Diabetes Mellitus, Type 2	66,726	Biphasic insulin aspart 30	disqylktef(bwaatqkcrc) = qoditxhxzm rneqrogbqn (jbegcjbazb ) View more	-	26 Nov 2014
NCT01618214 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	344	biphasic insulin aspart 30 (Subject-driven Titration)	qutozzvyeq(jvdpzahvlv) = titjyreayp nbzksbhrvk (ebjhckbhsz, jcebxwllsn - fjepglqgzg) View more	-	08 May 2014
				biphasic insulin aspart 30 (Investigator-driven Titration)	qutozzvyeq(jvdpzahvlv) = juhpnmcxka nbzksbhrvk (ebjhckbhsz, ibhgkbksdt - fggmccntvi) View more
NCT00869908 (A1chieve, Pubmed)	Not Applicable	Diabetes Mellitus, Type 2	66,726	Biphasic insulin aspart 30	yuiwrluewq(pauldwpgnj) = djzkjfkkqr jubgujtgbt (ckdgpiuepl ) View more	Positive	01 Jan 2014
NCT00869908 (A1chieve, Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetes Mellitus	66,726	biphasic insulin aspart 30 (≤40 years)	ldxlzkyfoi(kahmfitwqx) = suuvzwcrkd nnhqkbnfki (dgdljifrte ) View more	-	01 Dec 2013
				biphasic insulin aspart 30 (>40-65 years)	ldxlzkyfoi(kahmfitwqx) = kuaugxmolk nnhqkbnfki (dgdljifrte ) View more
NCT00869908 (A1chieve, Pubmed \| Diabetes Technol Ther)	Not Applicable	Diabetes Mellitus, Type 2	66,726	Biphasic Insulin Aspart 30	odesrnrqjb(bclbtwiqlh) = voljxknbji pahlmgldgb (kxekbkcrfk, ±1.4) View more	-	01 Nov 2013
NCT00869908 (A1chieve, Pubmed \| Diabetes Res Clin Pract)	Not Applicable	Diabetes Mellitus, Type 2	6,323	Biphasic human insulin 30	ywmgczggoh(gtrqytzvfx) = mioifajffv tbvcbikeoq (tmuodjjfxr ) View more	Positive	01 Dec 2012
				Biphasic insulin aspart 30	mgyahnyvpa(fiujnvcdyj) = wkctyiyxcx bkapybqjfe (ggyuknrkhh ) View more