Delving into the Latest Updates on Insulin detemir with Synapse

Overview

Basic Info

Drug Type

Peptide Hormone

Synonyms

Detemir, Insulin Detemir (Genetical Recombination), Insulin detemir (genetical recombination) (JAN)

+ [14]

Target

INSR

Action

agonists

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Inactive Indication

Cystic fibrosis related diabetesHypoglycemiaObesity

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/SNovo Nordisk, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (01 Jun 2004),

Diabetes Mellitus

Regulation-

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Structure/Sequence

Sequence Code 4857

Source: *****

Sequence Code 91440

Source: *****

This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.
The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.
Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.
Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.
The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.
During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.
Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.
Women cannot take part if they are of childbearing potential.

Start Date01 Dec 2021

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Insulin detemir

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100 Translational Medicine associated with Insulin detemir

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100 Patents (Medical) associated with Insulin detemir

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1,036

Literatures (Medical) associated with Insulin detemir

01 Jan 2026·ANNALS OF PHARMACOTHERAPY

Comparative Efficacy and Safety of Basal/Correctional Vs Basal/Bolus/Correctional Insulin Regimens in Medical Intensive Care Unit Patients Receiving Continuous Enteral Nutrition

Article

Author: Briscoe, Jessica ; Van Berkel Patel, Megan ; Cohen, Aaron ; Greenberg, Jeremy ; Parker, Jessica ; Caldwell, Lauren ; Stowe, Alicia

Background::

While glycemic control is essential in critically ill patients, the optimal insulin regimen for patients receiving continuous enteral nutrition (CEN) is unknown.

Objective::

This study compares glycemic control in basal/correctional vs basal/bolus/correctional insulin regimens in intensive care unit (ICU) patients receiving CEN.

Methods::

This retrospective study included patients ≥18 years old, admitted to the medical critical care service with administration of CEN and ≥20 units of insulin detemir daily for ≥48 hours. Patients receiving non-insulin hypoglycemic agents were excluded. The primary outcome was the comparison of glycemic control, assessed by mean blood glucose and percent of glucose checks in target range. Secondary outcomes included the comparison of hypoglycemia, hyperglycemic emergencies, and glycemic variability between groups.

Results::

A total of 100 patients were included, with 50 patients per group. Mean blood glucose and percent of blood glucose checks in the target range were similar between basal/correctional and basal/bolus/correctional groups (204.2 vs 194.2 mg/dL, P = 0.2433 and 37.8% vs 43.1%, P = 0.3182, respectively). There were no differences in hypoglycemia or hyperglycemic emergencies. Among patients receiving ≥60 units of insulin daily, the basal/bolus/correctional regimen was associated with lower mean blood glucose (197.1 vs 248.5 mg/dL, P < 0.0001) and increased glucose checks in target range (43.5% vs 9.1%, P = 0.0040) without increased hypoglycemia.

Conclusion and Relevance::

Among ICU patients requiring ≥20 units of insulin detemir daily while receiving CEN, basal/correctional and basal/bolus/correctional insulin regimens appear to offer similar glycemic control, but basal/bolus/correctional regimens may improve glycemic control in patients requiring ≥60 units of insulin daily.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada

Article

Author: Mau, Godfrey ; Garcia, David A. ; Singh, Sumeet ; Spence, Michaela ; Goldenberg, Ronald ; Jensen, Morten Sall

AIM:

Patients with type 2 diabetes (T2D) with poor glycemic control despite use of non-insulin agents can experience delay in initiating insulin therapy and poor adherence to insulin therapy, predominantly due to the burden of multiple injections^1-3. This study aimed to determine the cost-effectiveness of insulin icodec, first once-weekly basal insulin, compared with long-acting basal insulins for improving glycemic control in adults with T2D in Canada.

MATERIALS AND METHODS:

The Swedish Institute of Health Economics T2D Cohort Model was used to analyse three T2D groups: insulin naïve (IN), basal insulin experienced (BIE), and basal-bolus insulin experienced (BBIE). Comparators included insulin glargine, insulin detemir, and insulin degludec. Comparative efficacy was informed by the phase 3 ONWARDS trials of insulin icodec and network meta-analyses (NMA). Time horizon was 40 years. Analyses considered disutilities resulting from vascular complications, age, gender, diabetes duration, hypoglycemia, and injection burden. A 1.5% annual discount rate was used for costs and effects. The average cost per unit for each treatment, accounting for the market share of available formats and biosimilars was calculated. Outcomes were expressed as quality-adjusted life-years (QALYs) and cost-effectiveness as incremental cost utility ratios (ICUR [cost/QALY]).

RESULTS:

In all analyses, insulin icodec dominated insulin degludec and insulin detemir. Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and $45,433 in the IN, BIE, and BBIE populations, respectively.

LIMITATIONS:

Limitations of this economic evaluation include the lack of data for some treatments in certain NMAs, uncertainty regarding the use of the NMA results for a 40-year time horizon, heterogeneous sources of disutilities, and uncertainty regarding the HRQoL benefits of reduced injection frequency.

CONCLUSIONS:

Insulin icodec is a cost-effective treatment option for adult patients with T2D versus once daily basal insulin-analogues publicly reimbursed in Canada.

14 Nov 2025·JAVMA-JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION

Long-term antiepileptic therapy is often not required in dogs with insulin-induced hypoglycemic seizures: a multicenter retrospective study of 49 dogs

Article

Author: Verkinderen, Brandon ; Lane, Michael

Abstract:

Objective:

To characterize the clinical features, management, and short- and long-term outcomes of dogs experiencing insulin-induced hypoglycemic seizures (IIHS).

Methods:

Dogs with documented blood glucose concentrations < 80 mg/dL (4.4 mmol/L) within 12 hours of insulin administration were retrospectively identified from 14 private practice emergency and specialty hospitals in the US (January 2017 to January 2025). Dogs were classified as having IIHS or insulin-induced hypoglycemia (IIH) without seizures. Data collected included signalment, insulin type and dose, blood glucose concentration at presentation, time to glucose correction, seizure characteristics, antiepileptic drug (AED) use, length of hospitalization, and survival to discharge. Associations between clinical variables and seizure occurrence were assessed with logistic regression.

Results:

49 dogs met the inclusion criteria: 34 with and 15 without seizure activity. Body weight showed a curvilinear association with seizure occurrence, with higher odds at low (< 10-kg) and high (> 25-kg) weights (body weight: OR, 0.26; 95% CI, 0.07 to 0.97; body weight 2 : OR, 1.41; 95% CI, 1.04 to 1.93). Antiepileptic drugs were used in 7 of 34 dogs (20.6%); 3 required long-term management. Multiple seizures were associated with AED use. No significant differences were found in insulin type, amount administered, or time to glucose correction between groups.

Conclusions:

IIHS are common in diabetic dogs; however, long-term neurologic sequelae and the need for ongoing AEDs are uncommon.

Clinical Relevance:

Future studies are warranted to better identify patients at increased risk for long-term neurologic complications and to establish criteria for initiating AEDs. Additionally, research evaluating IIHS associated with other insulin preparations (eg, detemir, glargine) is needed.

41

News (Medical) associated with Insulin detemir

27 Mar 2026

·firstwordpharma.com

Novo's much-awaited weekly insulin Awiqli wins FDA nod in type 2 diabetes

After a lengthy regulatory delay, Novo Nordisk said Thursday it finally secured FDA approval for Awiqli (insulin icodec-abae), making it the first and only once-weekly, long-acting basal insulin authorised in the US for glycaemic control in adults with type 2 diabetes as an adjunct to diet and exercise. The product is expected to hit the shelves in the second half."Awiqli may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week," said Anna Windle, group VP of clinical development, medical & regulatory affairs at Novo, adding that "it's helping to reframe what basal insulin care can look like."The approval was supported by data from the Phase III ONWARDS programme, comprising four trials enrolling approximately 2680 adults with uncontrolled type 2 diabetes. Across the studies, once-weekly Awiqli, which was evaluated against daily basal insulin — both in combination with mealtime insulin and alongside oral anti-diabetic agents and/or GLP-1 receptor agonists — demonstrated notable efficacy on the primary endpoint of HbA1c reduction. Moreover, Awiqli's overall safety profile was consistent with the established daily basal insulin class.With patent protection long gone for Novo’s NovoLog (insulin aspart), NovoMix (biphasic insulin aspart) and Levemir (insulin detemir), coupled with Tresiba (insulin degludec) and Fiasp (faster-acting insulin aspart) set to lose exclusivity in 2029 and 2030, respectively, Morningstar analyst Karen Andersen recently said they "expect further insulin improvements — like…Awiqli — to continue to refresh the firm's insulin portfolio."Rocky road in the US Awiqli's US regulatory journey has been an arduous one. In 2023, the Danish drugmaker filed applications for the once-weekly insulin across the US, Europe and China in type 1 and 2 diabetes, with an FDA decision initially expected in April 2024. However, the FDA delayed the original target date by three months while convening an advisory committee meeting. Shortly thereafter, the panel voted 7–4 that data were insufficient to support a favourable benefit–risk profile of Awiqli in type 1 diabetes, echoing the agency staff's pre-meeting concerns over higher hypoglycaemia risk versus once daily Tresiba; the committee did not assess the drug's use in type 2 diabetes.In July 2024, the US regulator issued a complete response letter (CRL), seeking additional data relating to Awiqli's manufacturing process and its use in type 1 diabetes; however, there was no mention of the type 2 diabetes indication in the CRL. Subsequently, Novo resubmitted the application to the FDA in September 2025, this time specifically for adults with type 2 diabetes.Besides the US, the Novo product holds diabetes approvals in multiple regions, including the EU, Canada, Australia, Japan, Switzerland and China, with specific indications varying by market.Awiqli now gains a clear head start over Eli Lilly’s once-weekly basal insulin analogue efsitora alfa, which is currently under regulatory review in the US, EU and Japan for type 2 diabetes, backed by four registrational studies in the QWINT programme.

Drug ApprovalPhase 3

23 Apr 2025

·pharma.economictimes.indiatimes.com

Novo Nordisk to phase out some forms of Mixtard insulin, cos spot big opportunity

New Delhi: As Novo Nordisk prepares to phase out some forms of its human premix insulin brand Mixtard-a move seen overlapping with its planned launch of weight-loss drug Wegovy in India-other top insulin makers are rushing to ramp up production capacity to bridge the potential demand-supply gap the move is expected to create, said top company executives. The Danish pharma major, the maker of semaglutide blockbusters Ozempic and Wegovy, is planning to retire a range of insulin formulations available in easy-to-use disposable pen and cartridge forms by the end of this year. This would include human insulin in penfill and flexpen, including Mixtard 30 Penfill and Flexpen, Actrapid Penfill and Flexpen, Insulatard Penfill and Flexpen, and Mixtard 50 Penfill over the next six months. It will also phase out insulin brand Levemir in FlexPen and Xultophy FlexTouch (Insulin + GLP1). The company recently informed Abbott India about this planned phase-out, according to a document accessed by ET. Abbott is the marketing partner for Novo's insulin. Confirming the development, a Novo Nordisk spokesperson said, "In order to meet increasing patient demand and ensure a stable supply of our medicines, we have decided to consolidate our insulin portfolio, as this will create space needed in our global manufacturing network. Hence, in this process, we are phasing out the penfill." However, the company said it is not discontinuing Mixtard in India and "it will continue to be available in vials". The company did not provide any details on specific brands. "Along with it, other forms of insulins, including human insulins from Novo Nordisk, will continue to be available in vials and devices for patients across India," the spokesperson said. "With the decision, we strive not to leave any patients without alternative treatment options, either from Novo Nordisk or other companies. It is important to us that the transition to other devices or treatment options is as smooth as possible for patients." The phasing out of the penfill Mixtard creates an opportunity for other human premix insulin makers such as Lupin , Eris, Eli Lilly, Wockhardt and Cadila , said industry insiders. Amit Bakshi, MD, Eris Lifesciences , which is ramping up capacity to produce penfill insulin said, "Our strategy is to make sure how we are available through and through and how we can ramp up manufacturing." However, according to him the transition phase may be a "small level of emergency", as a lot of hoarding has been happening in the last couple of months after the news has been out, with several large stockists and patients increasing their stock. "We may not be able to take on all of the demand immediately but are planning to take 60-70% of it." By Rica Bhattacharyya & Vikas Dandekar ,

22 Apr 2025

·pharma.economictimes.indiatimes.com

Novo Nordisk to phase out its largest insulin brand in India

New Delhi: In a move which could shake up the diabetes market, Novo Nordisk is discontinuing the country’s largest selling insulin, Human Mixtard , among other older insulin brands in India. Human Mixtard alone is a Rs 800 crore brand for Novo Nordisk in India, despite it being under price control. Besides Human Mixtard, the phase-out could impact its top brands in the Rs 5,000 crore insulin market including Actrapid, Insulatard, Insulin Detemir and Levemir and Xultophy — marketed mostly in the format of pre-filled disposable pen and cartridges (Penfill and FlexPen). The company recently informed its marketing partner, Abbott India that the products would be discontinued once the current stocks are exhausted, documents accessed by TOI said. This could take about six months. The decision is in line with the global strategy of the Danish company to prioritise newer, patented blockbuster diabetes and weight loss therapies including Ozempic and Wegovy , due to their higher profitability, sources said. Also, it seems to be potentially in line with its plans to introduce these therapies in the Indian market this year. As part of its global strategy, earlier generation insulin products will be discontinued globally in a gradual manner. An email sent on April 17 to the company went unanswered. However, the company plans to continue selling Human Mixtard, Actrapid and Insulatard, in vials — which can be delivered to patients through injections. This may limit the access further as insulin delivery from pen devices is preferred by a huge majority of diabetics over vials injected with syringes, due to its accuracy, ease of dosing, and reduced stigma, a survey said earlier. By Rupali Mukherjee ,

AcquisitionDrug Approval

100 Deals associated with Insulin detemir

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External Link

KEGG	Wiki	ATC	Drug Bank
D04539	Insulin detemir	A10AE05	DB01307

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	United States	Novo Nordisk A/S	19 Oct 2005
Diabetes Mellitus, Type 2	United States	Novo Nordisk A/S	19 Oct 2005
Diabetes Mellitus	European Union	Novo Nordisk A/S	01 Jun 2004
Diabetes Mellitus	Iceland	Novo Nordisk A/S	01 Jun 2004
Diabetes Mellitus	Liechtenstein	Novo Nordisk A/S	01 Jun 2004
Diabetes Mellitus	Norway	Novo Nordisk A/S	01 Jun 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystic fibrosis related diabetes	Phase 3	United States	Novo Nordisk A/S	01 Aug 2008
Obesity	Phase 3	Spain	Novo Nordisk A/S	01 Apr 2005
Hypoglycemia	Phase 3	Australia	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	Croatia	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	Denmark	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	Italy	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	South Africa	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	Sweden	Novo Nordisk A/S	01 Sep 2001

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01186003 (CTgov)	Not Applicable	Diabetic Ketoacidosis \| Diabetes Mellitus, Type 1 \| Hyperglycemic Hyperosmolar Nonketotic Coma ... View more	30	insulin+detemir (Standard Insulin Drip Therapy)	xtqnqzownt = vvftohedfe dcslfiuknt (pfvehxgfoe, lexkammcxv - bakfhfkklz) View more	-	07 Dec 2021
				Detemir (Insulin Drip and Detemir)	xtqnqzownt = troysydwcz dcslfiuknt (pfvehxgfoe, byhaiopgrt - lpquscbrhb) View more
NCT03620890 (Determin, CTgov)	Phase 4	Diabetes Mellitus, Type 2	108	Detemir insulin (Detemir)	cubiyyjxfd = otmvxqsozn qlagyocnrn (uluuuzviag, mofxlultja - pxaqueshsc) View more	-	18 Aug 2021
				Neutral Protamine Hagedorn (NPH) (Neutral Protamine Hagedorn (NPH))	cubiyyjxfd = iobkjzvado qlagyocnrn (uluuuzviag, edqvjksxtx - fjqfyolskw) View more
NCT01892319 (EVOLVE, Pubmed \| Diabetes Care)	Not Applicable	Diabetes Mellitus	2,446	Insulin Detemir	ntszamgxzq(cibalisedv) = svgjfwzmxh ibzabqfwsk (zjnbssmgde ) View more	-	30 Jul 2021
				Other Basal Insulins	ntszamgxzq(cibalisedv) = oaaixfozhh ibzabqfwsk (zjnbssmgde ) View more
NCT02846233 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	22	SGLT2 inhibitor+levemir+Lantus+Metformin (Treatment Group)	sctqfviikj(npdvxcsyqv) = wzvefwmwwp yindlgpcai (fzblvvzlhc, tusseistxt - eaozifxbox) View more	-	10 Nov 2020
				SGLT2i (Control Group)	sctqfviikj(npdvxcsyqv) = degraiwsoc yindlgpcai (fzblvvzlhc, fgazhwiyrq - fktrrmyqww) View more
NCT01892319 (EVOLVE, EASD2020)	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	-	Insulin Detemir (IDet)	kaywrisdwy(sijuffxwtp) = vbmutpgqsn jwngxvwwsu (wwfxyytyax ) View more	Positive	23 Sep 2020
NCT01966978 (SIMPLE, CTgov)	Phase 4	Diabetes Mellitus, Type 2	157	Detemir+Metformin+Insulin Aspart (Control: Metformin, Insulin Detemir, Insulin Aspart)	rpbqglgzvs(chzeufzmxv) = holxnqrqvc hhkhrwbljn (dgbkczbpqc, rjfyfwybvj - orisaxqmgu) View more	-	22 Oct 2019
				Detemir+Liraglutide+Metformin (Metformin, Insulin Determir, Liraglutide)	rpbqglgzvs(chzeufzmxv) = xpnxssfdfz hhkhrwbljn (dgbkczbpqc, eoxnfiyhkq - kexmqovfjt) View more
NCT00564018 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	33	Insulin detemir (Detemir)	tssohbbllu(ashyvenftf) = ilxxmylkpt emifqmzkxf (mgtfotdvkw, pgvlqroujr - tmpfxgmovx) View more	-	11 Oct 2019
				Glargine (Glargine)	tssohbbllu(ashyvenftf) = oppltzmdkr emifqmzkxf (mgtfotdvkw, ffmcencgjo - dwranhjsfg) View more
NCT01232946 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	30	liraglutide (Iiraglutide)	rvofllpzsz(zfasuvdnny) = hfbdvcwixc otsljpngms (tcidiyfvac, wwpzvxlghm - bskgimnqqh) View more	-	07 Aug 2019
				insulin detemir (Insulin Detemir)	rvofllpzsz(zfasuvdnny) = rahvybeugc otsljpngms (tcidiyfvac, koizictzlu - yakbiptfyo) View more
NCT00564395 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	18	Insulin Detemir (Insulin Detemir Mixed With RAI Injection)	qrdxbdeiic(wdlszwzpwi) = kozcekogqg raevnpvagu (arkibyxhqd, 70) View more	-	17 Jul 2018
				RAI+Insulin Detemir (Insulin Detemir and RAI Injection Separately)	qrdxbdeiic(wdlszwzpwi) = kbwwpvmplg raevnpvagu (arkibyxhqd, 112) View more
NCT02741687 (CTgov)	Phase 4	Diabetes Mellitus \| Hyperglycemia	80	placebo+sitagliptin (Placebo)	qrkxzkothw = bfiiekjziq drvpkegzfu (zuqknjzvrd, wyigbcnbpx - rjjmyumtxp) View more	-	27 Jun 2018
				Sitagliptin (Sitagliptin)	qrkxzkothw = imauwvmlyz drvpkegzfu (zuqknjzvrd, dumrkmetso - zxxqkxdyyg) View more

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