This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.
This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

Start Date01 Aug 2024

Sponsor / Collaborator

The Ohio State University

[+2]

NCT05768191 / RecruitingPhase 4IIT

Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin in a Limited Resources Setting: a Multicenter Randomized Controlled Crossover Clinical Trial

The goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (Humulin 30/70) and those who have a basal bolus scheme (Humulin N + Humulin R) in a resources limited setting.
The main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals. At the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). Insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting [<110 mg/dl (6.1 mmol/liter)], bedtime [<130 mg/dl (7.2 mmol/liter)], and premeal [<110 mg/dl (6.1 mmol/liter)] glucose levels until HbA1c was below 7.0%.
Subjects will receive training on the FreeStyle Libre CGMS System, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (SMBG), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.

Start Date15 Jun 2023

Sponsor / Collaborator

Université Polytechnique de Bobo-Dioulasso

[+1]

NCT04118920 / Active, not recruitingPhase 1IIT

Safety of Topical Insulin Eye Drops for the Treatment of Open-angle Glaucoma

Glaucoma, a leading cause of irreversible blindness worldwide, is characterized by a permanent loss of retinal ganglion cells (RGCs), a group of central nervous system (CNS) neurons that convey visual information from the retina to the brain via their long axons. Clinically, axonal damage in RGC results in a loss of visual field and may lead to blindness. Currently, reducing eye pressure remains the sole target of proven glaucoma therapies. However, many patients continue to lose vision even when standard interventions are implemented, accentuating the unmet need for novel therapies.
Dendrites are processes that determine how neurons receive and integrate information. Dendrite retraction and synapse breakdown are early signs of several neurodegenerative disorders. In mammals, CNS neurons have an extremely limited capacity to regenerate after injury. To date, the ability of mammalian neurons to regrow dendrites and reestablish functional synapses has been largely ignored.
Insufficient insulin signaling has been implicated in diseases characterized by dendritic pathology, notably Alzheimer's disease and glaucoma. A versatile hormone, insulin readily crosses the blood-brain-barrier and influences numerous brain processes. In a mouse model of optic nerve transection, our team showed that insulin administration after optic nerve injury promoted robust dendritic regrowth, RGCs survival and retinal responses rescue, providing the first evidence of successful dendrite regeneration in mammalian neurons. Our research validates insulin as a powerful medication to restore dendritic function in glaucoma, forming the basis for using insulin as glaucoma treatment in humans.
Currently, insulin is approved for diabetes. Adverse events of systemic insulin include hypoglycemia, hypokalemia, lipodystrophy, allergies, weight gain, peripheral edema and drug interactions. Experimental use of ocular topical insulin have been tested in small cohorts of healthy individuals and diabetic patients, reporting no significant adverse events. However, these protocols varied in insulin posology and adverse events were only touched upon briefly, indicating the necessity to better characterize the safety profile of such off-label use of insulin before its application as a neuroprotective and regenerative treatment for glaucoma.
In this study, the investigators hypothesize that topical ocular insulin (up to 500 U/ml) at once per day dosing is safe in patients with open angle glaucoma.

Start Date27 Mar 2023

Sponsor / Collaborator

Fondation du Centre Hospitalier de l'Université de Montréal

100 Clinical Results associated with Insulin human(Eli Lilly & Co.)

100 Translational Medicine associated with Insulin human(Eli Lilly & Co.)

100 Patents (Medical) associated with Insulin human(Eli Lilly & Co.)

184

Literatures (Medical) associated with Insulin human(Eli Lilly & Co.)

01 Dec 2024·American Journal of Ophthalmology Case Reports

Topical insulin to treat a conjunctival defect after glaucoma surgery: A case report

Article

Author: Docherty, Gavin ; Iovieno, Alfonso ; Burgos-Blasco, Barbara ; Yeung, Sonia N.

PurposeInsulin has been postulated as a novel and effective treatment for re-epithelialization of the ocular surface and different pathologies have been suggested as possible indications.ObservationsA 69-year-old diabetic male was referred for a left non-healing conjunctival epithelial defect over the superotemporal scleral patch used in the placement of the Ahmed ClearPath. In the left eye, he was on latanoprost/timolol once daily, prednisolone 1 % once daily and tobramycin/dexamethasone ointment at night. Best-corrected visual acuity was 20/20 in the right eye and 20/25 in the left eye. Slit lamp examination of the left eye showed patches of avascular scleral tissue nasally and superiorly, conjunctival and Tenon defect over a thin avascular scleral patch graft. The patient was started on Humulin insulin 1UI/mL 6 times a day and the defect healed after 3 months of treatment.Conclusions and importanceInsulin eye drops may be used in the treatment of chronic conjunctival epithelial defects following implantation of glaucoma drainage devices.

09 Aug 2024·ACS Pharmacology & Translational Science

Therapeutic Insulin Analogue Concentrations at Infusion Sites Enhanced the Pro-Inflammatory Response and Apoptosis in an In Vitro Macrophage-Material Interaction Model

Article

Author: Fitzpatrick, Lindsay E ; Woodhouse, Kimberly A ; Zhang, Yuxi ; Kuo, Luke

Continuous subcutaneous insulin infusion for Type 1 diabetes relies upon insulin infusion sets (IIS) to reliably deliver insulin to a subcutaneous depot, where it is absorbed into systemic circulation. However, IIS are plagued by short wear times and high failure rates, due in part to inconsistent insulin absorption that can arise over time. While emerging evidence suggests that the local inflammatory response to the IIS cannula may impact both wear times and unreliable insulin adsorption, the mechanisms are poorly understood. Here, we investigated the effects of local infused insulin concentrations on the biomaterial host response to better understand the underlying factors that limit the IIS performance. We first modeled the insulin concentration for a constant basal infusion rate to select a relevant insulin concentration range of 0.1-10 U/mL within the infusion site. We then examined the influence of a commercial insulin analogue (Humulin-N) using an in vitro macrophage-material model, which uses adsorbed fibroblast lysate (containing damage-associated molecular patterns) to activate macrophages and recapitulates macrophage responses on implanted biomaterials. RAW-Blue macrophages cultured on lysate-adsorbed surfaces had increased nuclear factor-κB (NF-κB) and activating protein 1 (AP-1) activity and intracellular reactive oxygen species (ROS) accumulation compared to control surfaces. Humulin-N concentration (0.5-10 U/mL) enhanced the NF-κB/AP-1 activity and ROS accumulation in macrophages on lysate-adsorbed surfaces. However, Humulin-N had no effect on NF-κB/AP-1 or ROS in the absence of the inflammatory stimulus. Additionally, high insulin concentrations arising from therapeutic doses induced macrophage apoptosis with and without adsorbed lysate. This study contributes to emerging evidence that infused insulin affects the tissue response to IIS.

01 Jun 2024·British Journal of Pharmacology

Are insulin sensitizers the new strategy to treat Type 1 diabetes? A long‐acting dual amylin and calcitonin receptor agonist improves insulin‐mediated glycaemic control and controls body weight

Article

Author: Melander, Simone Anna ; Henriksen, Kim ; Larsen, Anna Thorsø ; Karsdal, Morten Asser

AbstractBackground and PurposeInsulin therapies for Type 1 diabetes (T1D) have limitations, such as glucose fluctuations, hypoglycaemia, and weight gain. Only pramlintide is approved with insulin. However, its short half‐life limits efficacy, requiring multiple daily injections and increasing hypoglycaemia risk. New strategies are needed to improve glycaemic control. Dual amylin and calcitonin receptor agonists are potent insulin sensitizers developed for Type 2 diabetes (T2D) as they improve glucose control, reduce body weight, and attenuate hyperglucagonemia. However, it is uncertain if they could be used to treat T1D.Experimental ApproachSprague Dawley rats received a single intravenous injection of streptozotocin (STZ) (50 mg·kg−1) to induce T1D. Humulin (1 U/200 g·day−1 or 2 U/200 g·day−1) was continuously infused, while half of the rats received additional KBP‐336 (4.5 nmol·kg−1 Q3D) treatment. Bodyweight, food intake, and blood glucose were monitored throughout the study. An oral glucose tolerance test was performed during the study.Key ResultsTreatment with Humulin or Humulin + KBP‐336 improved the health of STZ rats. Humulin increased body weight in STZ rats, but KBP‐336 attenuated these increases and maintained a significant weight loss. The combination exhibited greater blood glucose reductions than Humulin‐treated rats alone, reflected by improved HbA1c levels and glucose control. The combination prevented hyperglucagonemia, reduced amylin levels, and increased pancreatic insulin content, indicating improved insulin sensitivity and beta‐cell preservation.Conclusion and ImplicationsThe insulin sensitizer KBP‐336 lowered glucagon secretion while attenuating insulin‐induced weight gain. Additionally, KBP‐336 may prevent hypoglycaemia and improve insulin resistance, which could be a significant advantage for individuals with T1D seeking therapeutic benefits.

News (Medical) associated with Insulin human(Eli Lilly & Co.)

03 Sep 2024

·www.biospace.com

Opinion: The FDA Needs a Dedicated ‘Center for Rare Diseases’

Taylor Tieden for BioSpace The agency’s inertia and bureaucratic roadblocks are throttling hope for millions of patients. A new center of excellence would provide a solution. When I joined the FDA to be its “biotechnology czar” more than 40 years ago, genetic engineering was still a new concept. To fully grasp the nuances of the latest technological advances, we brought together experts in different scientific disciplines from across the organization. The first “biopharmaceutical” was human insulin synthesized in genetically engineered E. coli bacteria. Despite the novelty, we decided that because the FDA had prodigious experience with insulins sourced from pig and cow pancreases and also with drugs derived from various microorganisms, recombinant DNA techniques would be viewed as an extension or refinement of long-used and familiar methods for making drugs. Thus, no sui generis policies were required. That proved to be a historic, precedent-setting–and correct—decision. The human insulin, Humulin, was approved in a record-setting five months at a time when the average approval time for a New Drug Application was 31.5 months. Biopharmaceuticals now dominate the list of highest-revenue drugs and are critical to the health of tens of millions of patients. However, when it comes to another high-impact category of drugs, those for rare diseases, the FDA has a long way to go. When it comes to approving treatments for rare diseases, the Agency’s inefficient structure creates a confusing patchwork of policies that can lead to an inconsistent review process. There are over 10,000 rare diseases, some affecting only hundreds or even just dozens of Americans. In total, more than 30 million Americans live with a rare disease, but this large, vulnerable cohort has very little visibility outside of patients’ communities and support networks. There is currently no FDA-approved treatment for an estimated 95% of rare diseases, so millions of Americans (many of whom are children) face premature mortality, disability, severe pain, repeated hospitalizations and a drastically diminished quality of life. With such a large segment of our population living in a world without cures or treatments, you would think the FDA and its parent, the Department of Health and Human Services (HHS), would be doing everything in their power to usher in a new wave of innovation. But, perhaps unsurprisingly in government bureaucracies, they lack focus, coordination and an overarching strategy for addressing rare diseases. To become more effective in this area and to give hope to patients living on borrowed time, the FDA should establish a cross-cutting entity with a single leader to focus resources on the goal of getting treatments to rare-disease patients who need them without unnecessary delays. The FDA is Throttling Innovation In 1983 the Orphan Drug Act, which incentivized researchers to invest in new drugs and devices for rare diseases, was enacted. Before that landmark law was passed, just 38 rare disease drugs had been approved by the FDA; today, that number is well over 1,000. This is good news for patients, but much more must be done. The FDA continues to add and move boxes around on its organizational chart, but rare diseases continue to get short shrift, and innovation has suffered. Rare diseases are lumped into the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, which dilutes both the expertise and focus on rare diseases. A further complication is that many therapies for rare diseases are classified as “biologics,” which are regulated not by the Center for Drug Evaluation and Research but by the Center for Biologics Evaluation and Research. Different groups of bureaucrats may have different biases and approaches, which causes the goalposts for approval to be constantly shifted, leading to additional, costly, difficult-to-perform new trials. This situation arises because expertise in the highly specialized fields required to understand the spectrum of rare diseases and the mechanisms for treating them is scattered across the Agency. The conflicting guidance and advice given by different components of the FDA is not a prescription for efficiency and expert oversight, let alone advocacy for rare disease drugs. And the involvement of regulators who advocate for the expeditious testing and approval of the drugs is important: There is a saying in government that “Personnel = Policy.” Unfortunately, many pharmaceutical companies decide it’s simply not worth the hassle of the additional regulatory burden, or that they can’t afford the cost of providing drugs on a “compassionate use” basis and gathering new data. Consider these recent examples: In April, after years of deliberations, the FDA finally agreed to consider a drug to help an estimated patient population of 130–150 Americans. The review had been delayed after the agency gave the drugmaker conflicting requirements for data it needed to submit, and prior to the FDA’s acceptance of its application, the company had planned to abandon the drug. The same month, a company founded a quarter-century ago went bankrupt after the FDA kept moving the goalposts on its treatment for a disease that affects one in four million newborns and has been shown to extend children’s lives. (Inexplicably, the agency also failed to grant the company an approval or even an Emergency Use Authorization for its drug to treat COVID .) A Call to Action To prevent unnecessary roadblocks to vital medicines, the FDA needs an organization that understands and will focus on advocacy for rare-disease drugs. Last year, the FDA made a step in the right direction when it launched the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate “the pace of development of certain CBER- and CDER-regulated products (novel drug and biological products) that are intended to treat a rare disease.” To achieve this, the agency said: Selected [drug developers] will be able to interact with FDA through rapid, ad-hoc communication mechanisms to provide a mechanism for addressing program-specific development issues, including but not limited to clinical study design, choice of control group, fine-tuning the choice of patient population, leveraging nonclinical information, or product characterization. The FDA’s recent establishment of a Rare Disease Innovation Hub is another noteworthy advance in addressing the needs of patients with rare diseases, but more is needed. Building on these efforts, the FDA should now create a new organization resembling the agency’s Center of Excellence for Oncology to focus on getting more treatments to patients who have precious little time or options. Developing a Center of Excellence (or “Intercenter Institute”) for Rare Diseases under a single, dedicated director would further streamline rare disease development. This idea, which has the support of bipartisan members of Congress , would aggregate specialists and researchers on different types of rare diseases and organ systems to expedite the testing, evaluation and approval of drugs for rare diseases. Ultimately, it would enhance cross-Agency collaboration and expedite drug delivery to patients who currently lack options for treatment. Many of these treatments will be cutting-edge gene and cell therapies and combination therapies that require expertise across multiple disciplines to fully understand how they work. Institutional change won’t be easy, but it is necessary. A Center for Excellence for Rare Diseases would be an excellent start.

Drug ApprovalOrphan Drug

20 May 2024

·www.globenewswire.com

At278 Ultra-Concentrated Ultra-Rapid Acting Insulin Demonstrates Superiority in Phase i Clinical Trial in Overweight and Obese People With Type 2 Diabetes

Arecor Therapeutics plc(“Arecor” or “the Company”) AT278 ULTRA-CONCENTRATED ULTRA-RAPID ACTING INSULIN DEMONSTRATES SUPERIORITY IN PHASE I CLINICAL TRIAL IN OVERWEIGHT AND OBESE PEOPLE WITH TYPE 2 DIABETES AT278 demonstrates significantly accelerated PK/PD profile compared to NovoRapid® and Humulin® R U-500 in people with Type 2 Diabetes and high BMIConfirms previous trial results in people with Type 1 diabetes, demonstrating AT278 can maintain fast and superior onset of action and glucose lowering profile irrespective of diabetes type and BMIEnables delivery of a highly concentrated, low volume injection, offering more effective mealtime glucose control to meet growing unmet need in patients requiring high daily doses of insulin Creates potential to be the first, and only, ultra-concentrated (500 U/mL) ultra-rapid insulin product enabling miniaturisation of next-generation insulin pumpsCompany will host a CEO and key opinion leader webinar to discuss the results on Tuesday 21 May at 14.30 BST Cambridge, UK, 20 May 2024. Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today announces that its ultra-concentrated, ultra-rapid acting insulin candidate, AT278, met all primary and secondary endpoints, and also demonstrated superiority to NovoRapid® and Humulin® R U-500, in a Phase I clinical trial in Type 2 diabetics with a high body mass index (BMI). AT278 (500 U/mL) is an ultra-concentrated, ultra-rapid acting, novel formulation of insulin that accelerates the absorption of insulin post injection, even when delivered at a high concentration, and hence a lower injection volume. With no concentrated (>200 U/mL), rapid acting insulins on the market, AT278 has potential to be the first, and only, insulin available to the growing number of patients with high daily insulin requirements. Sarah Howell, Chief Executive Officer of Arecor, said: "We are delighted with the clinical results from this second Phase I study, demonstrating AT278’s superiority over NovoRapid® and Humulin® R U-500 in Type 2 diabetics with a high BMI. They further add to the positive results from our previous clinical study in Type 1 diabetic patients, where superiority was also demonstrated. This is a significant step in AT278’s development and extends our confidence in its clear potential to provide a superior insulin treatment option that lowers burden and improves outcomes for people living with diabetes who require high daily doses of insulin. Such patients make up a large segment of the target market. In addition, as the only concentrated, yet very rapid acting, insulin in development, AT278 has the capability to disrupt the market by enabling the next generation of truly miniaturised, longer-wear insulin pumps, a key focus for patients, physicians and the industry.” Many Type 2 diabetics with a high BMI are currently not well controlled, and improved treatments options such as AT278 are needed to reduce patient burden through fewer injections per day, reduced injection volumes and dosing flexibility around mealtimes. This lowering of burden for patients improves treatment adherence and, allied with AT278’s superior efficacy, should improve both blood glucose control and outcomes. In addition, a truly ultra-rapid, ultra-concentrated insulin is a critical step towards next-generation miniaturised and long-wearing insulin pumps, which are predicted to transform future diabetes management. Professor Thomas Pieber, Principal Investigator for the ARE-278-104 clinical trial, said: “These results are highly significant, AT278 has clearly demonstrated faster insulin absorption with an accelerated Pharmacokinetic (PK) and Pharmacodynamic (PD) profile compared to the lower concentration standard insulin aspart (NovoRapid®). The PK/PD profile of AT278 (500 U/mL) was also greatly accelerated compared to Humulin® R U-500 (500 U/mL). Together with its superior profile in the earlier Phase I clinical study in Type 1 diabetic patients1 AT278 has demonstrated its ability to maintain a fast and superior onset of action and glucose lowering profile irrespective of diabetes type and BMI. This makes AT278 completely unique in the competitive field of insulin analogues. Not only does it have the potential to significantly improve post-prandial glucose control whilst lowering burden for anybody with diabetes who has a high daily insulin need, it can act as a catalyst in the development of miniaturised insulin delivery systems, where the size of existing devices is a significant barrier to use for many patients.” In the double-blind, randomised, two-way crossover study, the pharmacokinetic (PK)/pharmacodynamic (PD) and safety profiles of a single subcutaneous (SC) dose of 0.5 U/kg AT278 (500 U/mL) were compared with those of a single SC dose of 0.5 U/kg NovoRapid® (100 U/mL), a currently available gold standard, rapid acting insulin treatment, in 39 participants with Type 2 diabetes within a BMI range of 25 and 39 kg/m2, in a euglycemic clamp setting. The PK/PD profile of 0.5 U/kg AT278 (500 U/mL) was also compared to a single SC dose of 0.5U/kg Humulin® R U-500 (500 U/mL) in an open label manner. The trial met the primary endpoint of non-inferiority with respect to glucose lowering actions compared with NovoRapid®AT278 (500 U/mL) demonstrated a significantly accelerated (superior) early PK/PD profile compared to NovoRapid® (100 U/mL), despite a 5-fold increase in concentrationAT278 (500 U/mL) demonstrated a significantly accelerated (superior) PK/PD profile compared to Humulin® R U-500 (500 U/mL), the only other insulin available at a concentration of 500 U/mL No safety signals were detected With around 537m people living with diabetes worldwide, there are growing numbers of people who require insulin to manage their blood glucose and, for many, their diabetes is still poorly controlled. There is a growing need for highly concentrated, much faster, and more physiological insulins to effectively manage diabetes. In the US alone, nearly 10% of insulin scripts written in 2022 were for products with a concentration of >100 U/mL2. Furthermore, despite the improvements in outcomes among people with diabetes who use insulin pumps and automated delivery systems, they are still only used by less than 40% of people with Type 1 diabetes and less than 10% of people with Type 2 diabetes in the US3. The size and short duration of wear of existing insulin pumps remains a significant barrier to use. AT278 has the potential to be the only highly concentrated, ultra-rapid acting insulin to enable the next generation of miniaturised, longer wear insulin pumps. The insulin pump market is valued at circa $5.5bn market today4, with a significant opportunity for substantial growth in this market by expanding use across the Type 1 and Type 2 patient population that can be further enabled by AT278 and a next generation insulin pump. A full analysis of the trial data is now underway to enable the Company to determine and pursue a strategy for AT278 that maximises value for shareholders and patients. Detailed data from the trial will be submitted for publication and presentation at a future international diabetes conference. AT278 clinical results CEO and KOL webinar - Tuesday 21 MayDr Sarah Howell, Chief Executive Officer, and Professor Thomas Pieber, Principal Investigator for the ARE-278-104 clinical trial and Professor of Medicine, Head of the Division of Endocrinology and Metabolism and Chairman of the Department of Internal Medicine at Medical University of Graz, Austria will host a CEO and key opinion leader webinar to discuss the clinical results on Tuesday 21 May at 14.30 BST. To register to join the live webcast click here and to register for the conference line to ask questions click here. Please contact ICR Consilium for details on arecor@consilium-comms.com. This announcement contains inside information for the purposes of the retained UK version of the EU Market Abuse Regulation (EU) 596/2014 ("UK MAR"). -ENDS- References Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes Care 2023;46(4):757–764: https://doi.org/10.2337/dc22-10542022 reports from Symphony. Retrieved October 2023Seagrove Partners Diabetes Bluebook 2022Insulin pump company annual reports and Company estimates For more information, please contact: Arecor Therapeutics plcwww.arecor.comDr Sarah Howell, Chief Executive OfficerTel: +44 (0) 1223 426060Email: info@arecor.com Susan Lowther, Chief Financial OfficerTel: +44 (0) 1223 426060Email: info@arecor.com Panmure Gordon (UK) Limited (NOMAD and Broker) Freddy Crossley, Emma Earl (Corporate Finance)Rupert Dearden (Corporate Broking)Tel: +44 (0) 20 7886 2500 WG Partners LLP (Financial Advisor) Nigel Barnes, Satheesh NadarajahDavid Wilson, Claes SpangTel: +44 (0)203 705 9321 ICR Consilium Chris Gardner, David Daley, Lindsey NevilleTel: +44 (0) 20 3709 5700Email: arecor@consilium-comms.com Notes to Editors About Arecor Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. The Arestat™ platform is supported by an extensive patent portfolio. For further details please see our website, www.arecor.com

Phase 1Clinical Result

05 Jan 2024

·www.biospace.com

Lilly Launches Direct-to-Consumer Website, Services to Support Weight-Loss Drugs

Pictured: Eli Lilly world headquarters/iStock, jetcityimage Eli Lilly is looking to bolster the commercial availability of its weight-loss drug Zepbound (tirzepatide) with the launch of a direct-to-consumer website and services to streamline access, the pharma giant announced Thursday. The new digital healthcare site called LillyDirect is designed for patients with obesity, migraines and diabetes. According to the company, the site will offer “disease management resources” giving consumers access to healthcare providers and providing home delivery of Lilly’s medicines through third-party pharmacy dispensing services. “A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes,” Lilly CEO David Ricks said in a statement. By obtaining the medicines—including Zepbound—from the company directly, patients can access “affordability solutions” in the form of saving cards that are automatically applied for patients who qualify, Lilly contends. Medicines that pharmacy service providers fulfill will also ship for free, according to Thursday’s announcement. Other medicines available on the site include Rezvoglar, Humulin, Humalog, Emgality, and Basaglar. LillyDirect will also provide patients with access to telehealth providers and allow for search tools to find healthcare professionals near patients if in-person care is preferred. “We know that people have come to depend on the efficiency and convenience of digital solutions to meet a variety of their everyday needs—healthcare being one of them,” Frank Cunningham, Lilly’s group vice president of global value and access, said in a statement. “We launched LillyDirect with the hope that it will offer patients an innovative end-to-end experience to manage their health and access their medicines so they can get back to living their lives.” Lilly will update the site and include new products, partners, and services in the future. On Thursday, Lilly also released an open letter warning against the use of its GLP-1 drugs Mounjaro and Zepbound for “cosmetic weight loss.” Lilly’s Zepbound injection was approved in November 2023 by the FDA and is meant for adults to manage chronic weight management issues including obesity with at least one weight-related condition such as high cholesterol or hypertension. In December 2023, a study published in the scientific journal JAMA found that patients taking the drug had regained weight after halting treatment. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Drug Approval

100 Deals associated with Insulin human(Eli Lilly & Co.)

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KEGG	Wiki	ATC	Drug Bank
D03230	Insulin human(Eli Lilly & Co.)	A10AF01 A10AD01 A10AC01 A10AB01 A10AE01	DB00030

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	FR	Lilly France SAS	30 Dec 1998
Diabetes Mellitus, Type 1	US	Eli Lilly & Co.	28 Oct 1982
Diabetes Mellitus, Type 2	US	Eli Lilly & Co.	28 Oct 1982

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	PR	Eli Lilly & Co.	20 Oct 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02588950 (CTgov)	Phase 1	Diabetes Mellitus, Type 2	11	U-500 insulin (U-500R) (100-U Bolus U-500R SC)	nrtimcdjmu(tcbpbcwlow) = jyotjqohve egbqagiwyw (acgaedxipm, fnfxunayve - ilpfbpkxyg) View more	-	18 Oct 2023
				U-500R+insulin (100-U Bolus U-500R CSII)	nrtimcdjmu(tcbpbcwlow) = bosnryyxba egbqagiwyw (acgaedxipm, basimxrxpl - brnqfqhkpi) View more
NCT03511521 (CTgov)	Phase 4	Insulin Resistance \| Steroid-induced hyperglycemia	3	Glargine+Humulin N+Novolin N+insulin aspart (NPH Insulin)	bajjynybzk(zjskgnuapz) = dshsalnart ouzkmgwetj (iytknzuqer, yzabagofec - rhwzoewcfq) View more	-	11 Sep 2020
				Glargine+insulin aspart (Basal/Bolus Insulin)	bajjynybzk(zjskgnuapz) = jykodegqdl ouzkmgwetj (iytknzuqer, wyvuzjjhvq - pbwjwoqxdw) View more
NCT02561078 (VIVID, CTgov)	Phase 3	Diabetes Mellitus, Type 2	420	Human regular U-500 insulin (CSII) (Human Regular U-500 Insulin Administered by CSII)	narlvktgql(maupmauonh) = wkstyjkjxq usxdvkrkvq (cfymrhsujn, kahwfzhoks - xwmnxkljxt) View more	-	20 May 2020
				Human regular U-500 insulin (MDI) (Human Regular U-500 Insulin Administered by MDI)	narlvktgql(maupmauonh) = lpcndidzch usxdvkrkvq (cfymrhsujn, kcjszixbnh - xjjxevzefc) View more
NCT01774968 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	325	Human Regular U-500 Insulin (Human Regular U-500 Insulin TID)	rdefyomfyo(svsuqfectg) = pwiltgmlya mzjuxjhyor (nvyjzxprpr, obygvjcjck - cjbyzhnuii) View more	-	12 May 2015
				Human Regular U-500 Insulin (Human Regular U-500 Insulin BID)	rdefyomfyo(svsuqfectg) = tlueatjfhe mzjuxjhyor (nvyjzxprpr, fjebgbxfby - rtwparepmj) View more
NCT00985712 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	263	HumaPen Luxura+Huminsulin Regular+insulin lispro (HumaPen Luxura)	mfvnucjnec(ytawtpvbpy) = deoypsighg lirjfjwilh (rnozvequdz, hbbokbckkc - rfoefhssrg) View more	-	04 Jun 2012
				HumaPen Memoir+Huminsulin Regular+insulin lispro (HumaPen Memoir)	mfvnucjnec(ytawtpvbpy) = lylbeejpel lirjfjwilh (rnozvequdz, ifomqgsbaf - afsdqrqtzr) View more

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis