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/S

Novo Nordisk Ltd.Novo Nordisk, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (01 Jun 2004),

Diabetes Mellitus

Regulation-

Login to view timeline

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

Login to view more data

100 Translational Medicine associated with Insulin detemir

Login to view more data

100 Patents (Medical) associated with Insulin detemir

Login to view more data

968

Literatures (Medical) associated with Insulin detemir

01 Aug 2026·DIABETES OBESITY & METABOLISM

Efficacy and Safety of Once‐Weekly and Once‐Daily Basal Insulins in Type 1 Diabetes Mellitus: A Systematic Review and Network Meta‐Analysis of Clinical Trials

Review

Author: Costa, Beatriz ; Alves, Carlos ; Mendes, Diogo ; Penedones, Ana ; Amaral, Ricardo

ABSTRACT:

Aims:

Once‐weekly basal insulins, icodec and efsitora alfa, were developed to improve treatment adherence and glycemic control and appear to be as effective as once‐daily degludec in reducing HbA1c in type 1 diabetes (T1DM). However, higher rates of clinically significant hypoglycemias were associated with both once‐weekly insulins. This network meta‐analysis compares the efficacy and safety of once‐weekly and once‐daily basal insulins in T1DM.

Methods:

PubMed and Embase were searched (up to April, 2025) to identify phase 3 clinical trials evaluating basal insulins in T1DM (icodec, efsitora alfa, degludec 100, glargine [100 and 300], detemir, and NPH). Change in HbA1c and weight, risk of hypoglycemias (overall and severe), and serious adverse events (AEs) were assessed at week 26 and 52.

Results:

Nineteen studies were included. At week 52, icodec reduced HbA1c more than degludec 100 (−0.17% [95% CrI: −0.28; −0.06]), glargine 100 (−0.17% [95% CrI: −0.32; −0.02]), detemir (−0.17% [95% CrI: −0.32; −0.02]), and NPH (−0.59% [95% CrI: −0.85; −0.34]), while efsitora alfa reduced HbA1c more than NPH (−0.45% [95% CrI: −0.70; −0.19]). Icodec showed a higher overall hypoglycemia risk at week 52 compared with degludec 100 (OR 1.64; 95% CrI 1.07–2.54) and detemir (OR 2.08; 95% CrI 1.01–4.39), but no increased risk of severe hypoglycemias or serious AEs.

Conclusions:

In T1DM, once‐weekly basal insulins appear broadly comparable in reducing HbA1c at week 52. Although icodec showed a higher overall hypoglycemia risk, evidence suggests a comparable risk of severe hypoglycemias between treatments.

01 Aug 2026·Biomedical Journal

The hidden link between diabetes and dementia: Findings from recent epidemiological studies

Review

Author: Tseng, Chin-Hsiao

Recent epidemiological studies investigating the link between diabetes mellitus and dementia or Alzheimer's disease are narratively reviewed. Diabetes mellitus is associated with a significantly higher risk of dementia by 56%, more predominant for vascular dementia than Alzheimer's disease and tau pathology is more remarkable than amyloid β deposition. The increased risk is related to the burden of microvascular and macrovascular diseases in a dose-response pattern; and a threshold effect between glycemic control and dementia risk is observed. A treatment target of hemoglobin A1c < 7% may be optimal for reducing the risk of dementia but hypoglycemia should be avoided. Antidiabetic drugs such as metformin, pioglitazone, sodium-glucose co-transporter 2 inhibitors and glucagon-like peptide 1 receptor agonists may show beneficial effects on dementia in observational studies. In a Taiwanese cohort study acarbose is also associated with a lower risk of dementia in female diabetes patients. When considering the repurposing of antidiabetic drugs in the treatment of patients with Alzheimer's disease, low-dose insulin detemir shows a promising effect in a network meta-analysis. A phase 3 clinical trial (MET-FINGER) is being conducted to investigate whether metformin plus lifestyle intervention can be effective in the prevention of Alzheimer's disease. Hyperuricemia, though considered a potential component of metabolic syndrome, seems to be associated with a lower risk of dementia. Sex hormones play some roles in cognitive function and females present a higher risk of dementia than males. However, additional studies are required to explore the impacts of sex and sex hormones on the development of dementia and Alzheimer's disease.

01 Jul 2026·DIABETES OBESITY & METABOLISM

The Silver Jubilee (2025) of Insulin Glargine: Introducing the Era of Long‐Acting Insulin Analogues for Diabetes Mellitus

Review

Author: Porcellati, Francesca ; Home, Philip D. ; Fanelli, Carmine G. ; Riddle, Matthew C. ; Yki‐Järvinen, Hannele ; Owens, David R. ; Becker, Reinhard H. ; Bolli, Geremia B. ; Lepore, Mauro ; Lucidi, Paola

ABSTRACT:

In the year 2000 the first once daily long‐acting bioengineered insulin analogue (LAIA), insulin glargine (‘glargine’), a true basal insulin (BI), became available for clinical use. This led to the decline in the 50‐year‐old era and prominence of the intermediate‐acting insulins, neutral protamine Hagedorn (NPH) and lente, requiring twice daily administration to control the basal metabolism of people with type 1 diabetes (T1DM) and type 2 diabetes (T2DM). This milestone bridged the gap between regimens involving unmodified human insulins of the previous century to those referred to as using ‘designer insulins’, with the introduction 4 years previously of the meal‐time analogue, insulin lispro. The rapid gain in popularity of glargine is explained by its clinical benefits (once‐daily dosing, titration to achieve improved pre‐breakfast plasma glucose, with a lower risk of nocturnal hypoglycaemia compared to NPH, and less frequent blood glucose monitoring). These benefits correlate with the pharmacokinetic/pharmacodynamic characteristics of insulin glargine being closer to physiological BI supply. In T2DM glargine changed the paradigm of insulin substitution by embedding the concept of ‘treating‐to‐target’, by starting BI ‘early’, with focus on near‐normal fasting plasma glucose prior to the introduction of prandial insulin, and more recently in combination with GLP‐1 receptor agonists. These practices/principles have continued with the introduction of additional innovative LAIAs for once‐daily or indeed weekly use. Today glargine remains in widespread worldwide use in people with T1DM and T2DM, is often the initial BI used, while it serves as a reference against which other LAIAs are tested in clinical trials.

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

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D04539	Insulin detemir	A10AE05	DB01307

R&D Status

Approved

10 top approved records.

Login

to view more data

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
Diabetes Mellitus	United Kingdom	Novo Nordisk Ltd.	01 Jun 2004

Developing

10 top R&D records.

Login

to view more data

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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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)	tdphazxmlf = rlohhjmxuh hlqhfxuvot (yfkrlnfhmh, yigxkczrvk - fmhkodiuwe) View more	-	07 Dec 2021
				Detemir (Insulin Drip and Detemir)	tdphazxmlf = kfijphxukh hlqhfxuvot (yfkrlnfhmh, vtrreykatn - dscztkvxqc) View more
NCT03620890 (Determin, CTgov)	Phase 4	Diabetes Mellitus, Type 2	108	Detemir insulin (Detemir)	abierjfuys = yhbeiafjwz gwbblrbiao (ytdtvtrlbv, hitncazipe - mwvworbihm) View more	-	18 Aug 2021
				Neutral Protamine Hagedorn (NPH) (Neutral Protamine Hagedorn (NPH))	abierjfuys = jyogdyvjxy gwbblrbiao (ytdtvtrlbv, ojzcvlgamj - ovfstpfvhs) View more
NCT01892319 (EVOLVE, Pubmed \| Diabetes Care)	Not Applicable	Diabetes Mellitus	2,446	Insulin Detemir	tivsgykmff(nlzszemcuw) = ytcxpdmqmn pjwobwdaol (wzkomczioo ) View more	-	30 Jul 2021
				Other Basal Insulins	tivsgykmff(nlzszemcuw) = jturaumezz pjwobwdaol (wzkomczioo ) View more
NCT02846233 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	22	SGLT2 inhibitor+levemir+Lantus+Metformin (Treatment Group)	xufujvjxii(mviytfnvay) = eogyghjwse baeridxypt (woludtpmzx, nwwyattnel - pnyvzhkhss) View more	-	10 Nov 2020
				SGLT2i (Control Group)	xufujvjxii(mviytfnvay) = ovxpqnnwbz baeridxypt (woludtpmzx, kftcradnwk - vqzcaczhev) View more
NCT01892319 (EVOLVE, EASD2020)	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	-	Insulin Detemir (IDet)	wmyrprphxi(mbqgszvrzn) = gihhfsmoxt ujepfjuuyp (unrfildakc ) 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)	bntcjoejdq(bqagxvicug) = icmodobntl eatwgzlcnb (cxmycjdnog, akibbufapo - qedslbaasd) View more	-	22 Oct 2019
				Detemir+Liraglutide+Metformin (Metformin, Insulin Determir, Liraglutide)	bntcjoejdq(bqagxvicug) = dqeggyinqq eatwgzlcnb (cxmycjdnog, zqqopztpsm - svykzcrnuy) View more
NCT00564018 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	33	Insulin detemir (Detemir)	rhagekagzm(hzurkadlth) = htospnbuem kypzyvkqhl (bmtpllyeiy, chidbewhvx - mhguqwtycp) View more	-	11 Oct 2019
				Glargine (Glargine)	rhagekagzm(hzurkadlth) = khcaqfrnwe kypzyvkqhl (bmtpllyeiy, nfwfcapzcg - vxdidhpyvq) View more
NCT01232946 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	30	liraglutide (Iiraglutide)	rtqfhakoib(wbehvfgshj) = bgxbftaurt khboqvprlv (acwcdwuqst, ouhgogkjek - peztojgrpm) View more	-	07 Aug 2019
				insulin detemir (Insulin Detemir)	rtqfhakoib(wbehvfgshj) = cszkcxtyzb khboqvprlv (acwcdwuqst, tabkihoely - bbgahfbgvm) View more
NCT00564395 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	18	Insulin Detemir (Insulin Detemir Mixed With RAI Injection)	anqlfpzgqy(ualmwrhdmi) = qoxhtqumwt dqtelffpau (axtwiaemcq, 70) View more	-	17 Jul 2018
				RAI+Insulin Detemir (Insulin Detemir and RAI Injection Separately)	anqlfpzgqy(ualmwrhdmi) = fpfkzadytf dqtelffpau (axtwiaemcq, 112) View more
NCT02741687 (CTgov)	Phase 4	Diabetes Mellitus \| Hyperglycemia	80	placebo+sitagliptin (Placebo)	lypmecfxim = ietkxodfwe oftufctiag (lfmdmxxomt, fjtofllgxi - cninndgkyk) View more	-	27 Jun 2018
				Sitagliptin (Sitagliptin)	lypmecfxim = oowvnjfhlh oftufctiag (lfmdmxxomt, rbemtqbewk - wrpkjxywzx) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data