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 Jan 2026

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 Date30 Jun 2025

Sponsor / Collaborator

Health Partners Institute For Education & Research

[+1]

NCT07007130

/ Not yet recruitingNot ApplicableIIT

Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial

Adhesion formation following laparoscopic pelvic surgery remains a significant cause of chronic pelvic pain, infertility, and surgical complications. Patients with insulin resistance (IR) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation. Intraperitoneal administration of insulin has shown promising results in animal models by modulating inflammatory mediators and enhancing fibrinolysis. This trial aims to evaluate the efficacy and safety of intraperitoneal insulin instillation at the end of laparoscopy in women with insulin resistance.

Start Date01 Jun 2025

Sponsor / Collaborator

Ain Shams University

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)

361

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

01 Aug 2025·ANESTHESIA AND ANALGESIA

In Vitro Investigation of Insulin Dynamics During 4 Hours of Simulated Cardiopulmonary Bypass

Article

Author: Schweizer, Thilo ; Schild, Christof ; Bally, Lia ; Vogt, Andreas ; Guensch, Dominik P. ; Nagler, Michael ; Galova, Barbara ; Nossen, Caroline M. ; Fischer, Kady ; Huber, Markus ; Siepe, Matthias

BACKGROUND::

Hyperglycemia is common in patients undergoing cardiovascular surgery with cardiopulmonary bypass. We hypothesize that intraoperative hyperglycemia may be, at least partially, attributable to insulin loss due to adhesion on artificial surfaces and/or degradation by hemolysis. Thus, our primary aim was to investigate the loss of insulin in 2 different isolated extracorporeal circulation circuits (ECCs), that is, a conventional ECC (cECC) with a roller pump, and a mini-ECC (MiECC) system with a centrifugal pump. The secondary aim was to assess and compare the relationship between changes in insulin concentration and the degree of hemolysis in our 2 ECC models.

METHODS::

Six cECC and 6 MiECC systems were primed with red packed blood cells and thawed fresh-frozen plasma (1:1). Four additional experiments were performed in cECC using only thawed fresh-frozen plasma. Human insulin (Actrapid) was added, targeting a plasma insulin concentration of 400 mU/L. Insulin concentration and hemolysis index were measured at baseline and hourly thereafter. The end points were the change in insulin level after 4 hours compared to baseline and hemolysis index after 4 hours. The insulin concentration and hemolysis index were analyzed by means of a saturated linear mixed-effect regression model with a random offset for each experiment to account for the repeated measure design of the study, resulting in mean estimates and 95% confidence intervals (CIs) of the primary end points as well as of pairwise contrasts with respect to ECC type.

RESULTS::

Insulin concentration decreased by 63% (95% CI, 48%–77%) in the MiECC and 92% (95% CI, 77%–106%) in the cECC system that contained red blood cells. Insulin loss was significantly higher in the cECC system compared to the MiECC (P = .022). In the cECC with only plasma, insulin did not significantly decrease (−4%; 95% CI, −21% to 14%). Hemolysis index in MiECC increased from 68 (95% CI, 46–91) to 76 (95% CI, 54–98) after 4 hours, in cECC from 81 (95% CI, 59–103) to 121 (95% CI, 99–143). Hemolysis index and percent change of insulin showed an excellent relationship (r = −0.99, P < .01).

CONCLUSIONS::

Our data showed that insulin levels substantially decreased during 4 hours of simulated cardiopulmonary bypass only in the ECC that contained hemoglobin. The decrease was more pronounced in the cECC, which also exhibited a greater degree of hemolysis. Our results suggest that insulin degradation by hemolysis products may be a stronger contributor to insulin loss than adhesion of insulin molecules to circuit surfaces.

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.

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

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

17 Feb 2025

·pharma.economictimes.indiatimes.com

At Rs 58 crore, cancer drug emerges top seller among new launches in 2024

New Delhi: Enhertu, an oncology drug marketed by UK giant AstraZeneca, topped the list of highest-selling new drugs in 2024, generating sales of nearly Rs 58 crore within its first year of launch. A cancer drug topping the sales charts also highlights the growing incidence of the disease in the country. In total, over 3,100 new brands were introduced during the year, collectively registering sales of Rs 1,097 crore, the latest data culled from IQVIA showed. The largest number of new brands were launched in the cardiac, anti-diabetic, and vitamins & minerals categories, reflecting the prevailing disease patterns across the country. AstraZeneca's Enhertu (trastuzumab deruxtecan) was followed by Sun Pharma which achieved sales of Rs 50 crore with 18 brands, and Dr Reddy's Rs 45 crore with 51 brands, the data showed. Among the brands launched in the last 12 months, gastro reported the highest value of Rs 167 crore from 394 brands, followed by anti-neoplast/immunomodulator (used in cancer therapy) with Rs 150 crore from 94 brands, and vitamins and minerals with a sale of Rs 126 crore from 505 brands. For context, the top-selling brand in the entire pharmaceutical market, either antibiotic Augmentin or anti-diabetic therapy Mixtard, generates around Rs 75-80 crore in monthly sales. Overall, the domestic pharma market stands at over Rs 2.2 lakh crore, with growth of a little over 8per cent. In Jan, the growth was led by price increases contributing over 5per cent, and new product introduction 2.6per cent, while volume growth was 0.9per cent. GSK's Augmentin continued to be number 1 brand with revenues of Rs 830 crore, growing by 9.3per cent for the 12-month period. Certain therapies outperformed the pharma retail market, including cardiac at 10.2per cent, gastro-intestinal at 10.9per cent, vitamins at 9.2per cent, neuro at 10per cent and derma at 10.1per cent. As against this, anti-infectives, anti-diabetic, respiratory, pain and gynaecology segments reported sluggish growth. The market is growing at a steady rate between 8-10per cent with certain players, including Sun Pharma and Torrent, exhibiting healthy double-digit growth, IQVIA data showed. By Rupali Mukherjee ,

Drug ApprovalBiosimilar

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	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	Novo Nordisk A/S	01 Apr 2003
Shock, Septic	Phase 3	Germany	HemoCue AB	01 Apr 2003
Shock, Septic	Phase 3	Germany	B. Braun Melsungen AG	01 Apr 2003
Diabetes Mellitus, Type 1	Phase 3	United States	Novo Nordisk A/S	01 Jun 2002
Diabetes Mellitus, Type 2	Phase 2	United States	Novo Nordisk A/S	06 Oct 2015
Sepsis	Clinical	United States	Novo Nordisk A/S	01 Jul 2003
Surgical Wound Infection	Clinical	United States	Novo Nordisk A/S	01 Jul 2003

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04115384 (CTgov)	Phase 2	Frontotemporal Dementia	3	Novolin-R insulin	nolqcofcxr = njpwlbdlpn vmuortkojg (dbaiikmesv, yznwycvxno - jeolrfeskt) View more	-	06 Jul 2023
NCT02415556 (MemAID, CTgov)	Phase 2	Diabetes Mellitus, Type 2	289	Regular Human Insulin (Type 2 Diabetes Mellitus - Insulin)	fzaesriomh(tpxacnsjos) = xjxgdylkql icxtcvxcjc (fmqsaqmhpe, 22.94) View more	-	17 Sep 2021
				Placebo (Type 2 Diabetes Mellitus - Placebo)	fzaesriomh(tpxacnsjos) = jtvyutegjh icxtcvxcjc (fmqsaqmhpe, 21.04) View more
NCT03511521 (CTgov)	Phase 4	Insulin Resistance \| Steroid-induced hyperglycemia	3	glargine+Humulin N+Novolin N+Insulin Aspart (NPH Insulin)	bgmiooxdpn(eqagqlwvuw) = fzislughwz dcwmlsfwdg (undlvuabij, 81.0) View more	-	11 Sep 2020
				glargine+Insulin Aspart (Basal/Bolus Insulin)	bgmiooxdpn(eqagqlwvuw) = swdvzrjsts dcwmlsfwdg (undlvuabij, 61.8) View more
NCT02064166 (CTgov)	Phase 2	Multiple System Atrophy \| Parkinson Disease	15	Intranasal Insulin (Insulin)	pqckpcgfhe(uzeqvajejy) = phzdnfdalh vlznfquwfb (vffxchmipr, emgtstobfk - ojjyogzaiu) View more	-	23 Nov 2018
				Intranasal Insulin (Placebo)	pqckpcgfhe(uzeqvajejy) = ytaemnjfhn vlznfquwfb (vffxchmipr, mtpymjcgjd - yirprqeggx) View more
NCT02138006 (SDIS, CTgov)	Not Applicable	Stroke \| Diabetes Mellitus, Type 1 \| Renal Insufficiency ... View more	102	Intensive insulin treatment (Intensive Insulin Treatment)	ualfruxxdb = xtlruvcnki ixmwwirbqy (optmfukvdg, kohmdscjzu - zlzlrymmrz) View more	-	21 Dec 2015
				Standard insulin treatment (Standard Insulin Treatment)	ualfruxxdb = jcdzwzjfzs ixmwwirbqy (optmfukvdg, krkysalwda - impmfebdeu) View more
NCT00391027 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	261	Exuber+Human Insulin (Inhaled Human Insulin (Exubera®))	zuknzkccrp(kumwapsbez) = qxnuszpihz mhnkzhrsfq (vviiqxbzlx, 1.19) View more	-	21 Oct 2009
				Lantus+Insulin Glargine (Insulin Glargine (Lantus®))	zuknzkccrp(kumwapsbez) = dobbqgqcuq mhnkzhrsfq (vviiqxbzlx, 1.14) View more

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