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

100 Translational Medicine associated with Insulin detemir

100 Patents (Medical) associated with Insulin detemir

972

Literatures (Medical) associated with Insulin detemir

01 Feb 2026·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

Diabetes in pregnancy and major new advances in diabetes care using long-acting and ultralong-acting insulins

Review

Author: Seif, Karl E ; Higgs, Arielle J ; Reece, E Albert ; Drummond, Rosa F

Pregestational diabetes complicates 1% to 2% of all pregnancies. Achievement of euglycemia prevents adverse maternal, fetal, and neonatal outcomes. Insulin is the first line and the backbone of diabetes treatment in and out of pregnancy, but the delicate balance between stringent control and hypoglycemia, along with the complexity and interruption of multiple injections per day, continues to make glycemic control challenging. The ideal basal insulin has a flat pharmacodynamic profile with minimal variability and is relatively easy for patients and clinicians to use. Insulin analogs, such as insulins glargine and detemir, are the most common basal insulins used in pregnancy at this time, but insulin degludec, which has advantages like prolonged duration of action in the nonpregnant population, was recently shown to be equally as effective as detemir in pregnancy. The ease of a once-daily injection without an increased risk of hypoglycemia is attractive to patients and clinicians who wish to simplify insulin regimens. Furthermore, there are current clinical trials evaluating once-weekly basal insulin regimens in the general population. This would decrease basal injections from a minimum of 365 per year to 52 per year, potentially increasing adherence and improving glycemic control. This review will discuss the evidence for insulin degludec in pregnancy as well as discuss the potential benefits and drawbacks of once-weekly ultralong-acting basal insulins in pregnancy.

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.

News (Medical) associated with Insulin detemir

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

05 Apr 2025

·endpts.com

Q&A: A conversation with GLP-1 co-discoverer Jens Juul Holst on the future of incretin-based drugs

Medicines based on glucagon-like peptide-1 (GLP-1) have revolutionized the treatment of diabetes and obesity. On Saturday, five scientists involved in the discovery and characterization of the peptide and its translation into therapeutic drugs were awarded one of the $3 million Breakthrough Prizes in Life Sciences, an award sometimes considered a precursor to a Nobel Prize. The five winners are: Svetlana Mojsov of The Rockefeller University; Lotte Bjerre Knudsen of Novo Nordisk; Jens Juul Holst of the Novo Nordisk Foundation Center for Basic Metabolic Research and the University of Copenhagen; Daniel Drucker of the University of Toronto and Sinai Health; and Joel Habener of Harvard University. Ahead of the announcement, Endpoints News spoke with Holst, the co-discoverer of GLP-1, about his career so far, and about future work. The conversation has been substantially edited for length and clarity. Another Breakthrough Prize went to the gene editing pioneer David Liu, who spoke with Endpoints’ Ryan Cross. Elizabeth Cairns : Congratulations! How does it feel to get this recognition? Jens Juul Holst : To tell you the truth, I didn’t know much about the Breakthrough Prize until I was notified some months ago. They forced me to wear black tie, which is something that I never have worn before. So it’s a bit of a surprise all the way through. Cairns : At least you’ve had a little while to get used to it. Are you proud? Holst : I’m extremely happy about these awards, not for my personal satisfaction, but because of the general appreciation of the work we’ve done. I’m a medical doctor and it’s fantastic to see these incredible results coming up in front of my eyes. It was something we hoped for, of course, but it was completely unpredictable many years ago when we uncovered this hormone. Cairns : You discovered GLP-1 in 1986. Did you realize how significant it was going to be? Holst : No. We found this insulin-releasing peptide, but there were many insulin-releasing peptides from the gut. Eventually we found out that it was the peptide that was responsible for low glucose levels in some of the patients we were helping. It turned out that compared to all the other insulin-releasing peptides, it did something else: It also inhibited glucagon secretion. That was really something. And we found that it was a very strong inhibitor of gastric emptying, and also intestinal transit. We also found that it was a neural mechanism, which turned our attention to the brain. Because this was a gut hormone and we knew that the gut would play a role in the regulation of food intake and appetite, we also looked at that, and sure enough, it also inhibited appetite. Cairns : How long did it take you to get from the discovery of the peptide to initial human research? Holst : That key step was in 1993, so it took quite some time. Cairns : What were the challenges you faced? Holst : That’s simple: money. Like most researchers we were relying on external support for our research, and throughout the early years, we were really short of support, forcing us to use old-fashioned, secondhand equipment and cheapest possible reagents, etc., and wages were kept at a minimum. But we got by, collaborating with friends who had been lucky to get better equipment. Cairns : Why do you think this recognition is coming now? Holst : That has to do with a development that nobody could have foreseen. That is the tremendous weight loss that the higher doses of the modern, long-acting agonists had. The effect on food intake was recognized early on. The question was how to harness this without having too many problems with side effects. People were brave. “OK, if we slowly up titrate, then maybe we can get to higher doses and get a greater weight loss.” And that was published in 2009 in The Lancet . That led to the approval of liraglutide [Saxenda] for obesity. This was a sensation. And in the meantime, a second generation GLP-1 had been launched for diabetes, and that was semaglutide [Ozempic/Wegovy]. I was there when it was developed. The weight loss was, again, something like 8%. Nothing sensational about that. But people did a new dose-response study this time with very small daily doses, and it turned out that you could get as high as something like 0.4 milligrams per day, and that would result in a 15% weight loss. And then the world went crazy. Cairns : It did indeed. This prize has been split five ways — were you all working in separate groups towards a similar end? Holst : Completely separately, yes. Although Lotte Bjerre, the chemist, she was a kind of a partner with me, we knew each other very well. What she did was to create liraglutide on the basis of the long-acting insulins Novo Nordisk was doing in those days. They were doing insulin detemir, which is long-acting because they attached the fatty acid to the molecule. She did that as well to GLP-1, and it worked. So she was responsible for the liraglutide part of it. Cairns : Where do you think research in this field might or should go in the future? Holst : People that are prescribed a GLP-1 agonist do not stay on therapy. One of the ways whereby GLP-1 agonists inhibit food intake is by inhibiting the reward mechanism, and this is very important because that is the same mechanism that is responsible for its effects on addiction — alcohol, opioids. Apparently there are fantastic effects on this. But the reward system also takes away some of the pleasure of eating. This is something that should be looked at in detail. Maybe it’s not fun to be on a GLP-1 receptor agonist. If your greatest pleasure in life is to eat good meals and that pleasure is taken away from you, what is left? In the meantime, there are other major problems to look at. One is to provide sufficient amounts of the GLP-1s, and get them to affordable prices. But they will be solved, there’s no doubt about that. There’ll be lots of producers of them, and that means that the prices will really fall and there will also be more products. Cairns : Are prizes like this becoming more important as a source of funding for this kind of research, especially with cuts to agencies like the NIH in the US? Holst : That’s a sneaky question because in principle, they’re personal, those prizes. I mean, it’s my money. Cairns : Yeah, absolutely. Sorry. Holst : I actually wanted to transfer some of the money for research, and it turned out that the part I wanted to transfer for research is being taxed. So it was quite expensive for me to transfer money for research from my personal prize. And frankly, the family didn’t think it was a good idea. They wanted the money. Cairns : So would I, I have to say. What do you intend to do with the money you’re keeping? Are you going to have a holiday, buy a car? Holst : A holiday? Christ, what is that? No. We have work to do. Cairns : The Breakthrough Prize is sometimes thought of as a harbinger for the Nobel. Do you think that GLP-1 research might win a Nobel in the future? Holst : They don’t apparently accept more than three recipients. That precludes a Nobel Prize for all the five of us. The scientific advance made by GLP-1 is big enough and suitable for the regulations of the Nobel Prize. But I have absolutely no idea what they’re going to think of in Stockholm. And it’s good enough as it is already. Cairns : If you do win, they’ll make you wear black tie again. Holst : Not even black tie, but white tie. It would be even worse!

100 Deals associated with Insulin detemir

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

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)	ybthpujnia = nmyaogllnh bxvioganpn (xvzwaejgiy, dhmsofrrjl - yambvgsmhb) View more	-	07 Dec 2021
				Detemir (Insulin Drip and Detemir)	ybthpujnia = kxsyokgrhz bxvioganpn (xvzwaejgiy, biokkkaadz - fqippcovdb) View more
NCT03620890 (Determin, CTgov)	Phase 4	Diabetes Mellitus, Type 2	108	Detemir insulin (Detemir)	elozjupztf = clpoupecjc umnkpmhdaz (vswdocmudl, ztijmeuejg - zthkxtffrd) View more	-	18 Aug 2021
				Neutral Protamine Hagedorn (NPH) (Neutral Protamine Hagedorn (NPH))	elozjupztf = qoxylhaxsm umnkpmhdaz (vswdocmudl, cvhylchkaz - qcgxyhpnsl) View more
NCT01892319 (EVOLVE, Pubmed \| Diabetes Care)	Not Applicable	Diabetes Mellitus	2,446	Insulin Detemir	zfqgfumnhh(diamzomptt) = vswwjzanje rxyhaklril (jqwddbavez ) View more	-	30 Jul 2021
				Other Basal Insulins	zfqgfumnhh(diamzomptt) = wpakkohhim rxyhaklril (jqwddbavez ) View more
NCT02846233 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	22	SGLT2 inhibitor+levemir+Lantus+Metformin (Treatment Group)	ahbtkwkvgd(hcdnosvlxc) = irpxervgji pgrltfeuam (cgtcwccrrf, tupxwzkvbh - qlzylpmvth) View more	-	10 Nov 2020
				SGLT2i (Control Group)	ahbtkwkvgd(hcdnosvlxc) = klabqdshqp pgrltfeuam (cgtcwccrrf, zqvhiutmlt - kbijjaghwn) View more
NCT01892319 (EVOLVE, EASD2020)	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	-	Insulin Detemir (IDet)	sykrxasvub(hxvxmwdduy) = kgnsrivcit xwjwswwpdk (xuufzqthsf ) 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)	fkwytgkrtk(ffhhextrbv) = zhtgepfico tdskfnzlcs (htmwwlkdmr, htnkxculaa - jmnwakefiz) View more	-	22 Oct 2019
				Detemir+Liraglutide+Metformin (Metformin, Insulin Determir, Liraglutide)	fkwytgkrtk(ffhhextrbv) = hprsnciogd tdskfnzlcs (htmwwlkdmr, bjpuejciqz - hncrcbiwoh) View more
NCT00564018 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	33	Insulin detemir (Detemir)	kxqxjpwjqn(txhmotoiok) = wkfxuqnxin morspimncw (oiufvqigzz, wizunslbvv - sckpviwpjg) View more	-	11 Oct 2019
				Glargine (Glargine)	kxqxjpwjqn(txhmotoiok) = hcxasqajvn morspimncw (oiufvqigzz, jyuzcubnlt - gkqwboivrq) View more
NCT01232946 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	30	liraglutide (Iiraglutide)	wnnfckdysi(jdcpirbrlq) = vumntlgrus ckauetkxph (dgwjuajiol, ocwxlydvqg - vujhlsusiw) View more	-	07 Aug 2019
				insulin detemir (Insulin Detemir)	wnnfckdysi(jdcpirbrlq) = nrgijmvbas ckauetkxph (dgwjuajiol, tzungprzco - vdfrgcbffb) View more
NCT00564395 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	18	Insulin Detemir (Insulin Detemir Mixed With RAI Injection)	qajixnowgu(dszdkipzwe) = nefgbujpsg wvvgovcppm (xcolwzokds, 70) View more	-	17 Jul 2018
				RAI+Insulin Detemir (Insulin Detemir and RAI Injection Separately)	qajixnowgu(dszdkipzwe) = uicsaipbao wvvgovcppm (xcolwzokds, 112) View more
NCT02741687 (CTgov)	Phase 4	Diabetes Mellitus \| Hyperglycemia	80	placebo+sitagliptin (Placebo)	irscpufeqy = osdmlzobpx rcwyefoczq (oszpnnjvnr, fdarrmalvo - nsdrimxkiv) View more	-	27 Jun 2018
				Sitagliptin (Sitagliptin)	irscpufeqy = ygbrkgithm rcwyefoczq (oszpnnjvnr, sjkdbgjhhy - hcopovzjnm) View more

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