This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.

Start Date01 Jun 2025

Sponsor / Collaborator

Columbia University

[+2]

NCT06434038

/ Not yet recruitingPhase 1IIT

Measurement of Insulin Levels in the Cerebrospinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose - Middle Age

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with neurological diseases such as mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.
18 healthy middle-aged adults will be randomly assigned to receive a single intranasal dose of 40 units insulin ("low dose" group), 80 units insulin ("high dose" group), or saline (placebo, or control group). Participants will undergo an image-guided lumbar puncture (spinal tap) performed by a study clinician. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of insulin to reach the brain after intranasal administration.

Start Date31 Mar 2025

Sponsor / Collaborator

Health Partners Institute For Education & Research

[+2]

NCT04809311

/ CompletedNot Applicable

Fully Decentralised Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Participants With Type 2 Diabetes Mellitus on Different Treatment Regimens

Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, everything will be handled without any visits to a hospital or doctor.
For collection of participants' blood glucose values participants will receive two different blood glucose monitors. One where participants cannot see the blood glucose values and one where participants can see the blood glucose values. Participants must wear them consecutively for 2 and 10 weeks, respectively. Further, participants will be asked to self-apply the monitors on their upper arm.
For collection of participants' activity data participants will receive an activity tracker, which participants will wear on the wrist throughout the study.
The study does not include any study medication and participants will continue the current antidiabetic treatment as prescribed to participants by their own physician. If any questions about the treatment and/or health condition while participating in the trial, participants should consult your own physician If participants are in doubt about what the blood glucose values mean or whether participants should react to the blood glucose values, participants need to contact the research staff or their general practitioner.

Start Date30 Apr 2024

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Insulin human (rDNA origin, Novo Nordisk)

100 Translational Medicine associated with Insulin human (rDNA origin, Novo Nordisk)

100 Patents (Medical) associated with Insulin human (rDNA origin, Novo Nordisk)

346

Literatures (Medical) associated with Insulin human (rDNA origin, Novo Nordisk)

01 Apr 2025·JOURNAL OF CONTROLLED RELEASE

BioJect: An in vitro platform to explore release dynamics of peptides in subcutaneous drug delivery

Article

Author: Qin, Qiuhua ; Wacker, Matthias G ; Kahouadji, Lyes ; Benetti, Ayça Altay ; Li, David

Predicting the release performance of subcutaneous (SC) drug formulations is challenging due to the complex interplay between physicochemical properties and the physiological microenvironment, which includes the extracellular matrix (ECM), fluid composition, and fluid availability, factors that collectively influence bioavailability and absorption rates. The ECM often acts as a bandpass filter modulated by local ion and protein content. In this study, we introduce the BioJect cell, a modern release test method based on the compendial flow-through cell, integrating a perfusion system with customizable biomatrix components. We systematically investigated the release mechanisms of four insulin formulations: regular human insulin, insulin aspart, insulin glulisine, and Neutral Protamine Hagedorn (NPH) insulin. A modified simulated subcutaneous interstitial fluid (mSSIF) comprising multiple components of the SC physiological environment was employed. It incorporates important ions and proteins (138.5 mM sodium, 10 mM potassium, 1.8 mM calcium, 0.8 mM magnesium, 111.3 mM chloride, 28 mM bicarbonate, 0.5 mM sulfate, 5 mM acetate, 4.2 mM phosphate, 30 g/L total protein added as bovine serum albumin). Our release test method discriminated the tested formulations under varying biorelevant conditions, demonstrating its biopredictive capabilities. Notably, we discovered a previously undocumented albumin binding affecting the release rate of insulin glulisine, likely occurring in the low-shear environment of SC tissue only. Additionally, the inclusion of biorelevant components like hyaluronic acid and collagen into the biomatrix of the BioJect cell provided profound insights into potential absorption and release mechanisms, supported by two in vitro-in vivo relationships (level C and level A). The BioJect cell represents a significant advancement in simulating the SC environment for drug release testing. Our findings highlight the importance of considering protein binding and ECM components in predicting drug absorption, offering a promising tool for the development and optimization of SC formulations.

01 Mar 2025·CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY

Drug‐associated glaucoma: A real‐world study based on the Food and Drug Administration adverse event reporting system database

Article

Author: Guan, Wen‐Ying ; Liu, Zuguo ; Hu, Jiaoyue ; Wang, Yu‐Qian ; Huang, Caihong ; Chen, Xiao‐Dong ; Wu, Shi‐Nan ; Wang, Shao‐Pan ; Yan, Dan

Abstract:

Background:

This study aims to assess the risk of drug‐associated glaucoma and track its epidemiological characteristics using real‐world data.

Methods:

Adverse event reports from the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to December 2023 were analysed. Disproportionality analysis and the Bayesian Confidence Propagation Neural Network algorithm were used. The study classified drugs associated with glaucoma, assessed risk levels, and compared drug‐induced times across different categories.

Results:

Eight hundred and five drugs were linked to glaucoma in the FAERS database. Disproportionality analysis identified 46 drugs with significant risk, mainly adrenergic medications (clobetasol propionate, fluocinolone acetonide), antihypertensives (hydrochlorothiazide), insulin (insulin human), anticholinergics (umeclidinium, darifenacin), VEGF inhibitors (brolucizumab, faricimab), and psychotropics (topiramate, ziprasidone). The top three high‐risk drugs were clobetasol propionate, umeclidinium, and fluocinolone acetonide. The shortest drug‐induced times were observed with indacaterol, salmeterol, and umeclidinium. Anticholinergic medications had the shortest drug‐induced time among all categories. Females (62.5%) and the elderly (average age 63.5 ± 16.8 years) were predominantly affected. Reports of drug‐associated glaucoma increased over the years.

Conclusion:

Preventing drug‐associated glaucoma is more effective than treatment. Identifying the risk and drug‐induced times of systemic and ophthalmic drugs can reduce occurrence risk. Clinical practitioners should be vigilant and inform patients of these risks.

02 Dec 2024·ChemMedChem

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

Article

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

Abstract:

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

News (Medical) associated with Insulin human (rDNA origin, Novo Nordisk)

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

14 Nov 2024

·www.fiercepharma.com

Citing 'capacity constraints,' Novo Nordisk plots global wind-down of human insulin pen production

In a statement, Novo acknowledged that “there is more to be done to support increased access and affordability of diabetes care in low- and middle-income countries." As sales of Novo Nordisk’s GLP-1 drugs for diabetes and obesity continue to soar, the Danish drugmaker is once again adjusting its insulin production priorities.“To address our current capacity constraints and reach more people with diabetes with our products in the future, our human insulin, which is currently delivered in pens and vials, will—over time—be transitioned to vials only,” a Novo Nordisk spokesperson told Fierce Pharma Thursday.These days, many diabetes patients in wealthier nations rely on analog insulin to control their blood sugar. Compared to human insulin, analog insulin tends to work faster and can be modified to alter the duration of action after injection. Analog insulin is often more expensive than human insulin, making the latter type more common in low- and middle-income countries (LMICs).Analog insulin will still be available in the pen format under Novo's plan. Back in June, The New York Times reported that South Africa’s public health system had run out of human insulin pens, which dovetailed with Novo’s decision not to renew its contract to supply the much-needed diabetes medication to the country after the agreement expired in May.At the time, the NYT noted that no other company had bid on the contract, which covered supply of 14 million pens for three years at roughly $2 per device. Novo had been supplying insulin pens to South Africa since 2014, the report added.“We appreciate the impact our portfolio decisions will have on patients in South Africa and understand the frustration this may cause,” Novo’s spokesperson said Thursday. The company is engaged in talks with local health authorities to make sure patients continue to have access to treatment, the spokesperson added.While insulin has formed the backbone of Novo Nordisk’s business for decades, the company is putting ever greater emphasis its newer generation of GLP-1 receptor agonists these days. Amid this shift, Novo has been laser-focused on boosting manufacturing capacity for its GLP-1s thanks to rampant demand for Ozempic for Type 2 diabetes and Wegovy for weight control.In 2024’s third quarter, Novo’s total insulin sales clocked in at 12.5 billion Danish kroner ($1.8 billion). Semaglutide-based Ozempic, by comparison, generated 29.8 billion kroner (around $4.3 billion), while Wegovy chipped in 17.3 billion kroner ($2.5 billion). Late last month, the FDA revised its online drug shortage database to list the 0.25-mg starter dose of Novo’s semgalutide med Wegovy as available. The starter presentation was the last dose of either Wegovy or its sister medicine Ozempic to be listed as in shortage by the U.S. regulator.That development came amid a global push to expand GLP-1 capacity, with Novo allocating $6.8 billion for manufacturing capital expansions this year. Besides growing its own production network, Novo's holding company is in the process of purchasing CDMO giant Catalent. When that deal closes, Novo Nordisk is slated to acquire three Catalent fill-finish sites from Novo Holdings for $11 billion. Meanwhile, Doctors Without Borders earlier this week called on three major insulin manufacturers—Eli Lilly, Novo Nordisk and Sanofi—to immediately cut the prices of their insulin pens to $1 per device in LMICs, citing cost as a major barrier to pen adoption in less-wealthy nations.

Acquisition

14 Nov 2024

·endpts.com

Novo Nordisk to phase out its production of human insulin pens globally

Novo Nordisk said Thursday that it plans to eventually halt all of its human insulin pen production globally, confirming an Endpoints News report from September . “We do continue to make human insulin in pens, but globally they will be phased out over time and human insulin will be available only in vials,” a Novo spokesperson told Endpoints via email. “We will continue to produce our insulin analogues in pens and vials.” The company did not provide any further information on how long the phase-out would take, or how it might use that manufacturing space for another product. Novo’s initial plans for the production downsizing were disclosed in September via discussions with Doctors Without Borders, who described them to Endpoints, as well as the WHO, the Australian government, and other governments and regulators. Novo previously emphasized to Endpoints that overall, it is still expanding its overall drug manufacturing significantly with the pending acquisition of three of Catalent’s facilities by Novo Holdings and other new investments.

Acquisition

100 Deals associated with Insulin human (rDNA origin, Novo Nordisk)

External Link

KEGG	Wiki	ATC	Drug Bank
D03230	-	A10AF01 A10AD01 A10AC01	DB00030

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, Inc.	25 Jun 1991
Diabetes Mellitus, Type 2	United States	Novo Nordisk, Inc.	25 Jun 1991
Hyperglycemia	United States	Novo Nordisk, Inc.	25 Jun 1991
Diabetes Mellitus	United States	Novo Nordisk, Inc.	30 Aug 1983

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Shock, Septic	Phase 3	Germany	B. Braun Melsungen AG	01 Apr 2003
Shock, Septic	Phase 3	Germany	Novo Nordisk A/S	01 Apr 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04115384 (CTgov)	Phase 2	Frontotemporal Dementia	3	Novolin-R insulin	yggroniwja = pjmtznhxmb nkhuokljzm (newdbmgzac, kbwqhxmnro - bbydmkywba) View more	-	06 Jul 2023
NCT02415556 (MemAID, CTgov)	Phase 2	Diabetes Mellitus, Noninsulin-Dependent, 2 \| Diabetes Mellitus, Type 2	289	Regular Human Insulin (Type 2 Diabetes Mellitus - Insulin)	ylubehzids(vkseirremy) = nibhulronp crxlxeswhj (rkchypzuyu, 22.94) View more	-	17 Sep 2021
				Placebo (Type 2 Diabetes Mellitus - Placebo)	ylubehzids(vkseirremy) = vuxhwrkvyu crxlxeswhj (rkchypzuyu, 21.04) View more
NCT03511521 (CTgov)	Phase 4	Insulin Resistance \| Steroid-induced hyperglycemia	3	Glargine+Humulin N+Insulin Aspart+Novolin N (NPH Insulin)	oqvjlshndl(trgbrdedrg) = uvshmkzjfr wjocytpnsd (axhovhjoxm, 81.0) View more	-	11 Sep 2020
				Glargine+Insulin Aspart (Basal/Bolus Insulin)	oqvjlshndl(trgbrdedrg) = decgdjuvoa wjocytpnsd (axhovhjoxm, 61.8) View more
NCT02138006 (SDIS, CTgov)	Not Applicable	Diabetes Mellitus, Type 1 \| Stroke \| Renal Insufficiency ... View more	102	Monotard (Intensive Insulin Treatment)	razdiqekba = tvaevqugcp losmswrtfu (tfmmrgaoqu, xsxpuuvwks - rbrijysrhg) View more	-	21 Dec 2015
				Standard insulin treatment (Standard Insulin Treatment)	razdiqekba = wvggvfoklh losmswrtfu (tfmmrgaoqu, rpitvrysen - plaiizqqgr) View more

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