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

NCT03960814

/ CompletedNot Applicable

Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine

This study will examine the influence of the basal insulins detemir and glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK). The data for this study will be drawn from the Clinical Practice Research Datalink (CPRD) Register.

Start Date21 May 2019

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

1,041

Literatures (Medical) associated with Insulin detemir

01 Feb 2025·JOURNAL OF SEPARATION SCIENCE

First Dimension Trap‐and‐Elute Combined with Second Dimension Reversed‐Phase Liquid Chromatography Separation Using a Two‐Dimensional‐Liquid Chromatography‐Tandem Mass Spectrometry System for Sensitive Quantification of Human Insulin and Six Insulin Analogs in Plasma: Improved Chromatographic Resolution and Stability Testing

Article

Author: Stejskal, David ; Jurica, Jan ; Handlos, Petr ; Sistik, Pavel ; Andelova, Katerina ; Handlosova, Klara ; Urinovska, Romana

ABSTRACT:

Multidimensional chromatography coupled to tandem mass spectrometry (MS/MS), including simple sample preparation with protein precipitation, anion conversion with ammonium hydroxide, and solid‐phase extraction using mixed‐mode anion exchange in a 96‐well plate format, has been validated for rapid simultaneous analysis of human insulin and its six analogs (lispro, glulisine, glargine, degludec, detemir, and aspart) in human plasma. This method is critical for clinical diagnostics, forensic investigations, and anti‐doping efforts due to the widespread use of these substances. In the present study, improved chromatographic resolution was achieved using a first‐dimension trap‐and‐elute configuration with an XBridge C18 (2.1 × 20 mm, 3.5 µm) trap column combined with second dimension separation on a Cortecs Ultra‐High‐Performance Liquid Chromatography (UHPLC) C18+ (2.1 × 100 mm, 1.6 µm) analytical column implemented within a two‐dimensional‐LC‐MS/MS system. The total chromatographic run time was 11 min. This setup increases both the resolution and sensitivity of the method. A mobile phase consisting of 0.8% formic acid (FA) in water and 0.7% FA in acetonitrile was used for gradient elution. Bovine insulin was used as the internal standard. MS detection was performed in positive electrospray ionization mode, and the ion suppression due to matrix effects was evaluated. Validation criteria included linearity, precision, accuracy, recovery, lower limit of quantitation, matrix effect, and stability tests with and without protease inhibitor cocktail under different conditions (short‐term stability, long‐term stability, and freeze‐thaw stability). The concentration range for all insulins was 50–15 000 pg/mL, with limits of quantification below the therapeutic reference range for all analytes. Intra‐run precision ranged from 1.1% to 5.7%, inter‐run precision from 0.7% to 5.9%, and overall recovery from 96.9% to 114.3%. The validated method has been implemented successfully by the Department of Forensic Medicine at our hospital for the investigation of unexplained deaths.

17 Jan 2025·MEDICINE

A short-course of low-dose insulin detemir effectively decreases blood glucose levels in gestational diabetic women undergoing dexamethasone treatment to promote newborn lung maturity

Article

Author: Chen, Jia ; Li, Ying-Tao ; Zeng, Li-Zhu ; Wu, Wei-Zhen ; Li, Si-Ying ; Wang, Yan ; Huang, Fang-Ying

Pregnant women with gestational diabetes mellitus undergoing glucocorticoid treatment to prevent neonatal respiratory distress syndrome could have increased glucose level. We performed a retrospective study and reviewed gestational diabetic women who received an intramuscular dexamethasone injection (6 mg, every 12 hours, 4 times) in our hospital between December 2018 and June 2020. Eligible pregnant women were assigned to the study group (with simultaneous subcutaneous insulin detemir injection, 2–4 units per day) or the control group (without insulin detemir injection). The fasting and 2-hour postprandial blood glucose levels were measured before and on days 1, 2, and 3 after the insulin detemir injection. The changes in their blood glucose levels were compared before and after the drug administrations as well as between the 2 groups. A total of 104 pregnant women were analyzed, including 48 women in the study group and 56 women in the control group. The blood glucose levels increased, with the peak levels occurring on the next day, after the dexamethasone administration in both groups. Compared with the control group, the study group had lower 2-hour postprandial blood glucose levels on days 2 and 3 after the insulin detemir injection (P < .05). There were no statistically significant differences in the fasting blood glucose levels between the 2 groups. Dexamethasone administration increased the blood glucose levels in the pregnant women with gestational diabetes mellitus. A short-course of low-dose insulin detemir administration effectively lowered the blood glucose levels in these women.

01 Jan 2025·Minerva obstetrics and gynecology

Safety and efficacy of insulin detemir vs. insulin NPH in pregnant women with diabetes: a systematic review and meta-analysis

Review

Author: Maniya, Muhammad T ; Fatima, Kaneez ; Rafique, Esha ; Shakil, Saad ; Siddiqi, Ahmed K ; Siddiqui, Khadija ; Quraishy, Maryam S ; Akhtar, Sareema E

INTRODUCTION:

The relative efficacy and safety of insulin neutral protamine Hagedorn (NPH) and detemir (IDet), in the management of diabetes in pregnancy remains unclear. We sought to conduct an updated systematic review and meta-analysis to study the effect of NPH versus IDet during pregnancy on clinically relevant maternal and fetal outcomes.

EVIDENCE ACQUISITION:

MEDLINE and Google Scholar were queried from inception till September 2022 for original studies comparing NPH with IDet for management of diabetes during pregnancy. Data was pooled using a random-effects model, to generate risk ratios (RR) for dichotomous outcomes and weighted mean differences (WMDs) for continuous outcomes, along with 95% confidence intervals (CIs). I² test was used to assess the magnitude of heterogeneity. Sensitivity analysis was conducted to explore the potential source of heterogeneity. As less than ten studies were included in our analysis, funnel plots were not made to evaluate publication bias. A P value of ≤0.05 was considered significant in all cases.

EVIDENCE SYNTHESIS:

Our search of the literature yielded 1087 articles initially, of which seven articles comprising 1396 patients, were included in our analysis. All included articles were of reasonably high methodological quality. Our pooled analysis demonstrates no statistically significant difference between the efficacy of insulin Detemir and insulin NPH as assessed by the HbA1c values from baseline. For safety outcomes, insulin detemir was significantly associated with a greater gestational age at delivery (WMD=0.39, 95%CI: 0.07 to 0.71, P=0.02) and lower incidence of hypoglycemic events (RR=0.64, 95%CI: 0.48 to 0.86, P=0.003) in-contrast to insulin NPH.

CONCLUSIONS:

Our findings demonstrate that both, insulin IDet and insulin NPH have a similar efficacy in reducing HbA1c from baseline. However, insulin detemir was associated with lesser incidence of maternal hypoglycemic events and greater gestational age at delivery, compared to NPH.

News (Medical) associated with Insulin detemir

05 Mar 2025

·www.biospace.com

Novo, Sanofi Hit With Anti-Competitive Probe in South Africa:

iStock, valiantsin suprunovich The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices. The South African government is investigating alleged anti-competitive practices by Novo Nordisk and Sanofi in connection with human insulin pens, Bloomberg reported on Monday evening. The Competition Commission of South Africa, the government’s anti-trust agency, is scrutinizing the companies’ device patents and proprietary designs to determine if these are being exploited to limit competition and block the entry of other developers and suppliers, as per Bloomberg. The watchdog is currently in the process of coordinating with Novo Nordisk’s and Sanofi’s local entities. BioSpace has reached out to Sanofi and Novo Nordisk for their statements and will update this article accordingly. The insulin market has seen some heavy upheaval over the last few years, driven by key policy changes around the world. Chief among these is the Inflation Reduction Act, signed into law in August 2022, and the Affordable Insulin Now Act, both of which seek to dramatically minimize Americans’ out-of-pocket spending for insulins. Pressure from lawmakers have also helped lower insulin prices in the U.S. The Competition Commission’s investigation comes shortly after it fined Google about $30 million per year for the next five years, while also investigating Meta and the social media network X (formerly Twitter), all for business practices that harmed South African media. Eli Lilly in March 2023 announced that it would lower insulin prices by 70% and cap out-of-pocket costs at $35 per month. Novo and Sanofi followed suit soon after, enacting their respective price cuts in the subsequent weeks. Months later, however, Novo announced that it would discontinue its long-acting insulin product Levemir, removing both the vials and pen from the market by the end of 2024. Lilly in Mach 2024 announced that due to marketing constraints, availability of two of its inulin products—Humalog an Lispro— would be limited . Sanofi also discontinued its pre-mixed insulin product Insuman, though this move mostly affected the U.K. and came in February 2023, a month before it announced the insulin price cuts. In a May 2024 interview with BioSpace , BMO Capital Markets analyst Evan Seigerman said that Novo “can’t make a product they’re losing money on, which may be the case with some insulins, and at some point they need to be smart with capital.” Still, the drugmakers continue to innovate on insulins. Lilly, for instance, is advancing a once-weekly insulin injection, Phase III readouts for which showed it could lower A1C by 1.34% , as compared with the 1.26% reduction for once-daily insulin degludec. Novo is also working on its own once-weekly product, dubbed insulin icodec. In July 2024, however, the program hit a regulatory road bump when the FDA rejected its drug application, flagging issues with the use of the product in type 1 diabetes.

Phase 3

06 Feb 2025

·www.echemi.com

Novo Nordisk Reports 2024 Earnings with $42.13 Billion Revenue and Impressive Profit Margins

On February 5, Novo Nordisk officially released its annual report for 2024, revealing a remarkable revenue of 29.04 billion Danish kroner (approximately $42.13 billion), representing a 25% increase year-on-year. The operating profit also surged to 12.83 billion Danish kroner (around $18.62 billion), reflecting a 25% growth, while net profit reached 10.10 billion Danish kroner (about $14.65 billion), up 21%. Notably, Novo Nordisk's profit margin (operating profit/sales) stands at an impressive 44.19%, far surpassing many American pharmaceutical giants. Novo Nordisk operates primarily in two business segments: Diabetes and Obesity Care and Rare Diseases. The majority of its revenue comes from the Diabetes and Obesity Care segment, which generated 27.18 billion Danish kroner in sales for 2024, while the Rare Diseases segment contributed only 1.86 billion Danish kroner. The GLP-1 class of drugs has emerged as Novo Nordisk's biggest revenue driver. Rybelsus (oral semaglutide) achieved sales of 23.30 billion Danish kroner (approximately $3.38 billion), while Ozempic (injectable semaglutide) brought in 120.34 billion Danish kroner (around $17.46 billion). The weight-loss version, Wegovy, also performed well with sales of 58.21 billion Danish kroner (about $8.44 billion). The total sales for semaglutide reached $29.28 billion, showcasing its strong performance, although it has not yet dethroned Keytruda as the new king of drugs. In addition to semaglutide, Novo Nordisk's GLP-1 offerings include the previous generation liraglutide, with Victoza (liraglutide for diabetes) and Saxenda (liraglutide for weight loss) generating 5.48 billion Danish kroner (approximately $795 million) and 6.94 billion Danish kroner (around $1.01 billion), respectively. Insulin remains Novo Nordisk's second-largest revenue generator, with total sales of 55.37 billion Danish kroner (approximately $8.03 billion) in 2024, driven by the success of degludec insulin, which saw a 15.3% increase in sales compared to the previous year. The three long-acting insulins—Tresiba (degludec), Xultophy (degludec/liraglutide), and Levemir (detemir)—achieved sales of 9.91 billion, 4.67 billion, and 4.50 billion Danish kroner, respectively. The two premixed insulins, Ryzodeg (degludec/aspart) and NovoMix (premixed aspart), generated revenues of 4.93 billion and 5.86 billion Danish kroner, respectively, with the former showing growth while the latter declined. Rapid-acting insulins, including Fiasp (ultra-rapid aspart) and NovoRapid (aspart), collectively sold 18.52 billion Danish kroner, an increase of approximately 2.6 billion compared to the previous year. Additionally, Novo Nordisk continues to sell second-generation human insulin, which generated 6.97 billion Danish kroner, although this segment saw a year-on-year decline. In the Rare Diseases segment, Novo Nordisk's product pipeline primarily includes clotting factors and growth hormones, with total sales of only 1.86 billion Danish kroner, representing a small portion of overall revenue. Unlike other major international pharmaceutical companies, Novo Nordisk has not pursued large-scale acquisitions and maintains a research and development investment intensity of around 15%. However, the company's sustained high revenue growth demonstrates its efficiency in product development. This efficiency can be attributed to four key factors: a strong focus on diabetes, extensive knowledge accumulation over a century, a commitment to user experience, maximizing market value from existing products, and the development of platform technologies. With advanced fatty acid acylation technology, peptide oral delivery technology, and yeast fermentation technology, Novo Nordisk is well-positioned to maintain its competitive edge in the market.

AcquisitionFinancial StatementDrug ApprovalBiosimilar

08 Jan 2025

·www.echemi.com

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

Drug ApprovalNDA

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.

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

Developing

10 top R&D records.

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2022	Not Applicable	Diabetes Mellitus, Type 2	-	Continued treatment with Gla-300	hdwxfyfdxc(twdhgvylzt) = zshyolprpu ebatvpiidl (qwsyyrpkbg ) View more	-	01 Jun 2022
				Switched to 1st-gen BI analog (Gla-100 or IDet)	hdwxfyfdxc(twdhgvylzt) = nwvteheoau ebatvpiidl (qwsyyrpkbg ) View more
NCT01186003 (CTgov)	Not Applicable	Diabetes Mellitus	30	insulin+detemir (Standard Insulin Drip Therapy)	yykujzdmpk = jkkqkwdrvf bsdgbeqfyj (nbttwfodul, qxjnefnghy - ddieeekdlm) View more	-	07 Dec 2021
				Detemir (Insulin Drip and Detemir)	yykujzdmpk = rjnzelvlot bsdgbeqfyj (nbttwfodul, uobskedzev - ezjqkjjxmn) View more
NCT03620890 (Determin, CTgov)	Phase 4	Diabetes Mellitus, Type 2	108	Detemir insulin (Detemir)	ocofayvvqt = kwzpdmevhr fpjgdwwiex (hcqhyajkjl, jhgcouifil - wgbvtxzhwu) View more	-	18 Aug 2021
				Neutral Protamine Hagedorn (NPH) (Neutral Protamine Hagedorn (NPH))	ocofayvvqt = iufzsotxob fpjgdwwiex (hcqhyajkjl, zsgyhvsrzo - nicgmcmgjh) View more
NCT02846233 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	22	SGLT2 inhibitor+levemir+Lantus+Metformin (Treatment Group)	uadjgcfuwj(mbmpgwufgr) = pwtnbdgnbi nvbapxsodf (bcdifoefca, scxthigyvj - pqycbdshkg) View more	-	10 Nov 2020
				SGLT2i (Control Group)	uadjgcfuwj(mbmpgwufgr) = owcgpehuda nvbapxsodf (bcdifoefca, wktifezrlx - mdssubufxo) View more
ASN2020	Not Applicable	Chronic Kidney Diseases	-	DPP-4 inhibitors	gyeesumshh(vagatyzytk) = lrrohtbgws wfpyzwuhib (ajrlrzrurv )	-	19 Oct 2020
				GLP-1 receptor agonists	rdrwwnyzud(vpsnefizpa) = gvykmjoanj zgfxlsvrpk (etpfhdyarg )
EASD2020	Not Applicable	Diabetes Mellitus, Type 2	-	NPH insulin	vhttogaxqm(bjlegddgkc) = xybjtcepfy mwkxfiavor (bmrmbetffm, 0.71 - 0.76)	-	24 Sep 2020
				Long-acting insulin analogs (glargine, detemir, degludec)	vhttogaxqm(bjlegddgkc) = bqcezmrjtc mwkxfiavor (bmrmbetffm, 0.02 - 0.03)
NCT01892319 (EVOLVE, EASD2020)	Not Applicable	Diabetes Mellitus, Type 1 \| Diabetes Mellitus, Type 2	-	Insulin Detemir (IDet)	rkxtvusjxz(pfjosnpsnf) = qapkvfgmzo aepsjypuht (duivtfjgfe ) View more	Positive	23 Sep 2020
NCT01966978 (SIMPLE, CTgov)	Phase 4	Diabetes Mellitus, Type 2	157	Insulin Aspart+Detemir+Metformin (Control: Metformin, Insulin Detemir, Insulin Aspart)	bswknseuoq(agvfmmvicf) = kjuxuqjtan biupymwoin (vtzccyygpd, moculcmntl - bvgdmagrse) View more	-	22 Oct 2019
				Detemir+liraglutide+Metformin (Metformin, Insulin Determir, Liraglutide)	bswknseuoq(agvfmmvicf) = ejdzifhugl biupymwoin (vtzccyygpd, pahxqhqqiu - wtwsitzmcf) View more
NCT00564018 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	33	Insulin detemir (Detemir)	dyyhhbgmzk(drqvuavvyp) = ggbyynkhvx fvjcwedqqe (yhaagcxixz, ikpufjlnjr - ellqkcftku) View more	-	11 Oct 2019
				glargine (Glargine)	dyyhhbgmzk(drqvuavvyp) = ryovhdpemh fvjcwedqqe (yhaagcxixz, itagpdzylh - uxsdpswexr) View more
NCT01232946 (CTgov)	Not Applicable	Diabetes Mellitus, Type 2	30	liraglutide (Iiraglutide)	nfntwpphsd(garmypnozn) = atwnhxyygx srntivsrij (daopkewert, zkccltdcbp - xnxtamdarq) View more	-	07 Aug 2019
				Insulin detemir (Insulin Detemir)	nfntwpphsd(garmypnozn) = sbrtyogieg srntivsrij (daopkewert, eotabrlgyq - jcnfijysoc) View more

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