A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes

The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.

Start Date28 Jan 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT06547619

/ RecruitingEarly Phase 1IIT

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

Start Date01 Oct 2024

Sponsor / Collaborator

University of Iowa

NCT06532461

/ RecruitingNot ApplicableIIT

A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes

More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

Start Date20 Jul 2024

Sponsor / Collaborator

Steno Diabetes Center A/S

100 Clinical Results associated with Insulin aspart

100 Translational Medicine associated with Insulin aspart

100 Patents (Medical) associated with Insulin aspart

1,409

Literatures (Medical) associated with Insulin aspart

02 Jan 2025·EXPERT OPINION ON PHARMACOTHERAPY

Evaluating semaglutide + LAI-287 (IcoSema) for the treatment of diabetes mellitus type II

Review

Author: Davis, Stephen N. ; Siamashvili, Maka

INTRODUCTION:

A stepwise coordinated multiple therapeutic targeted approach to the treatment of type 2 diabetes includes starting with lifestyle modification, oral antihyperglycemic agents, non-insulin injectables (Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), and both short and long-acting insulins. Ultra-long-acting insulins offer more convenient administration. As in any chronic disease, the introduction of a novel medication must balance safety, efficacy, financial cost, as well as improved patient convenience and adherence.

AREAS COVERED:

This manuscript describes IcoSema - a new investigational fixed-ratio combination of basal insulin icodec and the GLP-1 RA semaglutide. The key trials from the clinical development process of insulin icodec, semaglutide, and IcoSema are reviewed with important endpoints highlighted.

EXPERT OPINION:

Once-weekly IcoSema offers glycemic efficacy that is non-inferior to glargine+aspart, similar risk of hypoglycemia, significant reduction in body weight, the convenience of use, and favorable safety profile with most adverse events being gastrointestinal.

01 Jan 2025·DIABETIC MEDICINE

Sensor‐derived glycaemic metrics in pregnant women with type 1 diabetes randomised to faster acting insulin aspart or insulin aspart—A secondary analysis of the CopenFast trial

Article

Author: Clausen, Tine D. ; Nørgaard, Sidse K. ; Søholm, Julie C. ; Mathiesen, Elisabeth R. ; Ringholm, Lene ; Damm, Peter ; Nørgaard, Kirsten

Abstract:

Aims:

We compared sensor‐derived glycaemic metrics in pregnant women with type 1 diabetes (T1D) randomised to faster acting insulin aspart (faster aspart) or insulin aspart (IAsp).

Methods:

A pre‐planned secondary analysis of the CopenFast trial included women with T1D using intermittently scanned continuous glucose monitoring (isCGM) during pregnancy. Glycaemic metrics, including time in range (TIRp, 3.5–7.8 mmol/L) and time below range in pregnancy (TBRp, <3.5 mmol/L), were evaluated in the intervals: from randomisation (median 9.5 weeks, interquartile range 9.0–11.0) to 21 weeks, from 22 to 33 weeks and from 34 to 37 weeks.

Results:

In total, 113 (91%) of 124 women using isCGM in the original trial were included. At randomisation, glycaemic metrics were comparable in both groups. Women randomised to faster aspart achieved higher TIRp from 22 to 33 weeks (estimated treatment difference 5.1% [95% confidence interval 0.3; 9.7], p = 0.04) and mean TIRp >70% from randomisation to 21 weeks onwards, while this was achieved after 34 weeks in women randomised to IAsp. TBRp remained stable around 4% throughout pregnancy in both groups. One (2%) versus 5 (9%) experienced ≥1 severe hypoglycaemic event (odds ratio 0.93 [−0.2; −0.01], p = 0.04). Infant birthweight standard deviation score was lower in the faster aspart group (estimated treatment difference −0.5 [−0.9; −0.03], p = 0.04); however, this attenuated when adjusting for parity (p = 0.10).

Conclusions:

Women using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. Infant birthweight was lower and thereby more appropriate in the faster aspart group; however, this attenuated when adjusting for parity.

02 Dec 2024·ChemMedChem

Higher Order Structure Differences Among Insulin Crystalline Drugs Revealed by 2D heteronuclear NMR

Article

Author: Rienstra, Chad M. ; Wang, Songlin ; Chen, Kang

Abstract:

During therapeutic protein development, two‐dimensional (2D) heteronuclear NMR spectra can be a powerful analytical method for measuring protein higher order structure (HOS) in solution since the spectra exhibit much higher resolution than homonuclear 1H spectra. However, 2D NMR capabilities for characterizing protein HOS in crystalline states remain to be assessed, given the low 13C natural abundance and intrinsically broader lines in solid‐state NMR (SSNMR). Herein, high‐resolution heteronuclear correlation (HETCOR) SSNMR was utilized to directly measure intact crystal drug products of insulin human, insulin analogs of insulin lispro and insulin aspart. The fingerprint regions in 2D 1H−13C HETCOR spectra were identified, which distinguished the insulin crystals in their primary structure, HOS heterogeneity and dynamics, as well as the manufacturing processes. The HOS heterogeneity in insulin analogs is consistent with their therapeutic effect of rapid action; while insulin human crystals showed more structural homogeneity, consistent with their slower pharmacokinetics (PK) peak time than insulin analogs. Therefore, heteronuclear NMR could be broadly applicable to study protein drug dosage forms from liquid to solid, yielding improved molecular level structure data for assessing drug HOS in biosimilar drug development.

News (Medical) associated with Insulin aspart

17 Jan 2025

·www.pharmaceutical-technology.com

Ozempic named in latest Medicare price negotiations

The IRA was introduced in 2022 and aims to curb inflation by allowing Medicare to negotiate prices and rebates for certain drugs. Credit: designer491 via Getty Images. The US government has unveiled 15 additional drugs that will be covered in the next round of Medicare Part D price negotiations under the Inflation Reduction Act (IRA). Among the drugs selected in this round are Novo Nordisk’s blockbuster weight loss medication semaglutide, sold as Ozempic and Wegovy, Pfizer’s breast cancer drug Ibrance (palbociclib), and Pfizer and Astellas’s cancer medicine Xtandi (enzalutamide), as well as treatments for asthma and other chronic conditions. Drug manufacturers have until 28 February 2025, to decide whether to participate in negotiations. After the negotiations with participating drug companies later this year, new prices will become effective in 2027. The potential inclusion of semaglutide was expected even before the list. This was given the amount of Medicare spending on the drug and this will likely have the most impact, says Cyrus Fan, a research analyst at GlobalData. The announcement was made on the last working day of the Biden administration as Donald J.Trump will be sworn in as the US President on 20 January. “With the incoming Trump administration, it is not clear if any changes will come for the IRA negotiations. Though, what we will likely see is more pushback from the pharma industry,” says Fan. From November 2023 to October 2024, approximately 5.3 million Medicare Part D beneficiaries used these drugs to treat conditions such as cancer, type 2 diabetes, and asthma, with these medications accounting for $41bn – or 14% – of gross covered prescription drug costs under the programme, according to the US Department of Health and Human Services (HHS). This marks the second cycle of negotiations under the IRA, building on the 2023 selection of ten drugs . When all drugs included in both cycles are taken together, they represent over a third of the total gross prescription drug costs under Medicare Part D. In future years, CMS plans to expand the programme further, selecting up to 15 drugs for the third cycle and up to 20 drugs in subsequent cycles. This will include drugs covered under both Medicare Part B and Part D, as outlined in the IRA. The IRA was introduced in 2022 and aims to curb inflation by allowing Medicare to negotiate prices and rebates for certain drugs. Industry critics have said the IRA has far-reaching implications for biotech and pharma companies , including reduced drug pricing for Medicare patients, diminished returns for investors, and altered business strategies. The pharma lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) was quick to issued a statement decrying the announcement. “The IRA price setting process is dangerous for millions of Americans who rely on innovative treatments and created unnecessary, costly bureaucracy. In rushing out this list in their final days, the Biden administration once again fails to address the true challenges facing seniors and Medicare.” The programme has faced sharp opposition from the pharmaceutical industry, which argues that the negotiation process amounts to government price-setting and violates the US Constitution . Nearly all manufacturers involved in the first round of negotiations filed lawsuits challenging the IRA, but federal courts have dismissed most of these cases, citing that participation in the programme is voluntary and companies can opt out of Medicare if they disagree with the terms. Several companies have appealed these rulings, continuing their efforts to block or modify the programme. The first cycle of negotiations, completed in 2023, achieved price reductions ranging from 38% to 79% for the selected drugs, including a 79% cut for MSD’s Januvia (sitagliptin) and a 76% reduction for Novo Nordisk’s branded insulin aspart products. However, several experts have said the true impact of these reductions remains uncertain due to the lack of transparency around existing rebates and discounts already negotiated by Medicare Part D plan providers.

Financial Statement

17 Jan 2025

·www.biopharmadive.com

Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Medicares next drug price negotiations will treat Novo Nordisks semaglutide as a single product, regardless of whether the metabolic disease medicine is used to treat diabetes or heart risk, and whether it is delivered by shot or pill.Semaglutide was one of 15 drugs the Centers for Medicare and Medicaid Services selected Friday for a second round of price talks set up by the Inflation Reduction Act. Besides semaglutide, which Novo Nordisk sells as Ozempic, Rybelsus and Wegovy, the agency also chose other diabetes drugs, respiratory therapies and several cancer treatments.CMS treatment of semaglutide as one product is because the agency focuses on a drugs active moiety, or the core compound that has a biological effect, rather than treat each use approved by the Food and Drug Administration separately.The statute and our guidance [are] very clear that when a drug is selected for negotiation, all dosage forms and strengths with the same active ingredients are included, even if they are sold under different formulations or brand names, said Erin Richardson, CMS chief of staff, on a call with reporters.Ozempic was approved in 2017, making semaglutide subject to negotiation for the first time in 2025 under rules laid out in the Inflation Reduction Act. Eli Lillys competing products Mounjaro and Zepbound, which contain the active ingredient tirzepatide, gained first approval in 2022, meaning they wouldnt be subject to price negotiation until 2030.While semaglutide is widely covered within Medicare for diabetes, the health insurance program is not currently permitted by law to reimburse for treating weight loss, where Novo has since 2021 sold semaglutide as Wegovy.Wegovy is also approved to lower cardiovascular risk in people with heart disease and who are either overweight or have obesity, however. Medicare determined last March that this use could be covered under Part D plans. And the Biden administration last fall proposed a new rule permitting Medicare to cover obesity treatment more broadly.The maximum fair price the U.S. government negotiates under these talks will be a single cost. Dosage strengths, formulations and packaging prices for Ozempic, Rybelsus and Wegovy would be adjusted to meet that monthly price.Semaglutide products in Medicare are also already likely to be discounted from their list prices $998 a month for Ozempic and Rybelsus, $1,349 a month for Wegovy although CMS officials wouldnt confirm that Part D insurance plans receive rebates. In 2023, Novo paid 62% of its gross sales back in rebates across its sales. Of roughly $88.3 billion in gross sales, about $32 billion was paid back in rebates to Medicare and U.S. managed care plans.We remain committed to working with policymakers to advance solutions to ensure access and affordability for all patients, a Novo spokesperson said in an emailed statement. That is why we are deeply concerned about the price-setting process, which could negatively impact patients ability to access their medicines and threatens to stifle future scientific development of life-changing medicines for chronic diseases in which there is a real unmet need.Negotiations over semaglutide will be Novos second time discussing price concessions with CMS. The first round of talks, which yielded prices set to take effect in 2026, included insulin aspart, which Novo sells as several different products.That selection triggered a lawsuit from Novo, citing CMS inclusion of multiple products by way of selecting one active ingredient.That suit could provide an opportunity, albeit a long shot, to exempt Wegovy and Rybelsus from this round of price negotiations. CMS in its guidance said it applies price negotiations across products using the same active ingredient or moiety because it reduces the incentive for companies to engage in product hopping, or making small changes in drug formulation to extend patent-protected exclusivity.Novo claimed the guidance went beyond what the IRA allowed because it interpreted the laws call for price negotiations on drug products and biological products to mean all those with the same active moiety or ingredient. By grouping together all of Novos insulin products, CMS invoked negotiations on more than the 10 products permitted by the IRA in the initial round, Novo argued.The courts so far have rejected Novos lawsuit, ruling in July the company was effectively suing on behalf of other manufacturers when it made that claim, which it doesnt have standing to do. Novo has appealed.Whether CMS will be able to carry out its plans and even whether the program will survive a Trump administration and Republican Congress seeking to undo the work of the Biden administration is subject to some question. Already, drugmakers are reportedly planning to ask the Trump administration to pause negotiations.On the call with reporters, CMS officials emphasized their selections were guided by the Inflation Reduction act, noting that any other team that followed statute would end up choosing the same slate of 15 medicines. '

Drug ApprovalPatent Infringement

05 Dec 2024

·www.drugs.com

Novo Nordisk to Lower U.S. List Prices for Tresiba and Fiasp by More Than 70%

PLAINSBORO, N.J., Dec. 05, 2024 -- Novo Nordisk today announced plans to reduce the US list prices of two insulin products by more than 70% to better meet the needs of people living with diabetes . The list prices of vials and pre-filled pens of insulin aspart (rapid-acting) and basal insulin (long-acting), specifically Tresiba ® and Fiasp ® , will be reduced in the US starting January 1, 2026. Those new list prices, also referred to as wholesale acquisition costs (WAC), will be: The list prices of Fiasp ® will be reduced by 75%, matching the price of NovoLog ® . Additionally, the list prices of Tresiba ® will be reduced by 72.2%, making it 20% lower than its unbranded biologic equivalent, insulin degludec, thereby rendering the latter redundant. As such, Novo Nordisk Pharma, Inc. will discontinue the unbranded biologic versions below by December 31, 2025. Novo Nordisk is making healthcare professionals, wholesalers and payers aware of the discontinuations more than 12 months in advance, so they can enable smooth transitions to other options. Patients should speak with their healthcare professional about their treatment options to determine the best course of action. Novo Nordisk remains steadfast in its commitment to patients and recognizes that accessing medicines is a real challenge for people living with diabetes. To help as many people as possible, Novo Nordisk continues to offer a variety of insulin affordability options for people with or without insurance through NovoCare. In 2023 alone, NovoCare helped nearly 1.5 million people living with diabetes. Patients can visit NovoCare.com for more information. 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 more than 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, 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 commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, X, LinkedIn and YouTube. Source: Novo Nordisk Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Insulin aspart

External Link

KEGG	Wiki	ATC	Drug Bank
D04475	Insulin aspart	A10AD05 A10AB05	DB01306

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	JP	Novo Nordisk A/S	20 Sep 2019
Diabetes Mellitus	EU	Novo Nordisk A/S	07 Sep 1999
Diabetes Mellitus	IS	Novo Nordisk A/S	07 Sep 1999
Diabetes Mellitus	LI	Novo Nordisk A/S	07 Sep 1999
Diabetes Mellitus	NO	Novo Nordisk A/S	07 Sep 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	ES	Novo Nordisk A/S	01 Apr 2005
Acute Lymphoblastic Leukemia	Phase 3	US	Novo Nordisk A/S	01 Apr 2004
Adult Lymphoblastic Lymphoma	Phase 3	US	Novo Nordisk A/S	01 Apr 2004
Burkitt Lymphoma	Phase 3	US	Novo Nordisk A/S	01 Apr 2004
Lymphoma	Phase 3	US	Novo Nordisk A/S	01 Apr 2004
Hypoglycemia	Phase 3	AU	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	HR	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	DK	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	IT	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	ZA	Novo Nordisk A/S	01 Sep 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03659799 (Pubmed)	Phase 4	Diabetes Mellitus, Type 1	40	insulin type (ultra-rapid vs rapid insulin) (Rapid aspart)	dlatahbgwy(kfyeqbytvx) = asamnchfgy rhpffhtlwa (qybudrdvey )	Positive	29 Jul 2024
				insulin type (ultra-rapid vs rapid insulin) (Exercise at 60 min post meal)	diiovuqhnq(uduqhrnebd) = ezbdpaouce znuxdekusz (ednlylfkus, 1.2 - 100%)
NCT04538352 (TRANSITION-T2D, CTgov)	Phase 4	Diabetes Mellitus, Type 2	60	Insulin Degludec+semaglutide+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	uzjwkehyvk(fzaokyirja) = zxkhqwnagz wtsooelqcr (tburmfvsdu, mypxjrmayt - fscwhpvhui) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	uzjwkehyvk(fzaokyirja) = sxnxaglxmk wtsooelqcr (tburmfvsdu, xrxmdpbrem - nbokahnvpa) View more
820-P (ADA2024)	Not Applicable	Diabetes Mellitus, Type 1	-	Faster-Acting Insulin Aspart (Fiasp)	bkorqdgwzj(eaxlmrkmsr) = yomtffolci gcywfelfbo (gmuheugbvx, 12.3) View more	Positive	14 Jun 2024
				Insulin Aspart (Iasp)	bkorqdgwzj(eaxlmrkmsr) = harcewkxyq gcywfelfbo (gmuheugbvx, 12.1) View more
NCT04588259 (CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	331	Insulin degludec+Faster aspart	hdvpqzlgha(zuualdgqxi) = agooeclsaz nuroogysva (laqrfrztri, zyzcrwzcub - tijcnqnehx) View more	-	20 Mar 2024
NCT04460326 (In-FI, CTgov)	Phase 3	Diabetes Mellitus, Type 2	137	Insulin Glargine+NovoLog (Group 1 Insulin Glargine and Novolog)	axahjtakfc(qtvdrvgwfy) = cjylrpdjgr tzrlqshoed (viitzlrusq, hspmborhec - lcohiklqpc) View more	-	19 Mar 2024
				Insulin Glargine+Insulin Fiasp (Group 2 Insulin Glargine and Fiasp)	axahjtakfc(qtvdrvgwfy) = txeshhzlks tzrlqshoed (viitzlrusq, yfrgplxcwh - tabshhbvnm) View more
NCT00913497 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	16	insulin glulisine (Insulin Glulisine)	ajbtnwdhfc(eztrlditev) = kgtkoddxod yhcxpowjwi (wvctmvvssm, xvzgdexmgr - fdemjjzucc) View more	-	18 Sep 2023
				Insulin Aspart (Insulin Aspart)	ajbtnwdhfc(eztrlditev) = cimstdcudt yhcxpowjwi (wvctmvvssm, imathbfjsu - lsxasilktn) View more
NCT04853030 (Pubmed \| Diabetes Technol Ther)	Not Applicable	Diabetes Mellitus, Type 1	30	Faster Insulin Aspart	qfcvspnuij(qmgxbubcsv) = zsgipymapz sauwupmyrv (gkotvtkgjf ) View more	Negative	01 Sep 2023
				Standard Insulin Aspart	qfcvspnuij(qmgxbubcsv) = ufwgggazda sauwupmyrv (gkotvtkgjf ) View more
NCT03895515 (Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 1	178	Fast-Acting Insulin Aspart	gdlodpyifx(ljhjukdxmo) = ftpfdyyrqp ddetsjirou (rxbofqosxo )	Positive	14 Jul 2023
ADA2023	Not Applicable	-	29	AT247	qwwpckaipl(kibrupxebd) = xhtejkbwxz bsjddzrcmy (ffelqoyvqz )	-	20 Jun 2023
				NovoLog	qwwpckaipl(kibrupxebd) = vqmkwpvwni bsjddzrcmy (ffelqoyvqz, *)
CopenFast Trial (ADA2023)	Not Applicable	Diabetes Mellitus, Type 1	216	Faster-acting insulin aspart	trtzcsmxzq(xhpzqjhdnr) = cbajoolycd hakmvtddoc (mzgtqrzhdb, 38 - 46) View more	-	20 Jun 2023
				Insulin aspart	trtzcsmxzq(xhpzqjhdnr) = xooqvzdrcq hakmvtddoc (mzgtqrzhdb, 39 - 46) View more

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