A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.
The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

Start Date18 Apr 2024

Sponsor / Collaborator

Eli Lilly & Co.

[+1]

NCT06717191

/ CompletedPhase 4IIT

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth With Diabetes in Pakistan

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Pakistan

Start Date09 Jun 2022

Sponsor / Collaborator-

NCT06674135

/ CompletedPhase 4IIT

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh

Start Date01 Jun 2022

Sponsor / Collaborator

Bangladesh Institute of Research and Rehabilitation for Diabetes Endocrine and Metabolic Disorders

[+1]

100 Clinical Results associated with Insulin Glargine(Boehringer Ingelheim)

100 Translational Medicine associated with Insulin Glargine(Boehringer Ingelheim)

100 Patents (Medical) associated with Insulin Glargine(Boehringer Ingelheim)

Literatures (Medical) associated with Insulin Glargine(Boehringer Ingelheim)

01 Sep 2026·Lancet Diabetes & Endocrinology

Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial

Article

Author: Flabe, Ajmina Hasan ; Kirsch, Jill ; Majaliwa, Edna ; Kehlenbrink, Sylvia ; Zabeen, Bedowra ; Ansbro, Éimhín ; Rollman, Bruce L ; Prust, Margaret L ; Foulds, Abigail ; Lalama, Christina M ; Kayange, Neema ; Luo, Jing ; Ogle, Graham D ; Chang, Chung-Chou H ; Nyarubamba, Renatus Fabiano ; Ramaiya, Kaushik ; Garvin, Alana

BACKGROUND:

Human insulins including intermediate-acting human insulin (ie, isophane insulin) remain widely used for children and young people with type 1 diabetes, especially in low-resource settings. We aimed to assess whether insulin glargine reduces the risk of serious hypoglycaemia or improves time in range when compared against human isophane insulin among children and young people with type 1 diabetes in low-income and middle-income countries.

METHODS:

HumAn-1 was a randomised, open label, parallel-group trial conducted at one site in Bangladesh and two sites in Tanzania. Participants aged 7-25 years with a clinical diagnosis of type 1 diabetes were randomly assigned (1:1) to receive insulin glargine (Basaglar, Eli Lilly, Indianapolis, IN, USA) or to continue usual care (ie, isophane insulin or premixed 70/30) for basal insulin coverage. Insulin glargine was administered subcutaneously, usually before bedtime. Isophane insulin or premixed 70/30 was administered once or twice per day, at the discretion of the treating clinician. Doses varied by participant. Randomisation was performed centrally and stratified by site. The coprimary outcomes, measured using blinded continuous glucose monitors at 6 months, were time in very low range (<3 mmol/L or 54 mg/dL) and time in target range (3·9 mmol/L to 10·0 mmol/L or 70 mg/dL to 180 mg/dL). The primary analysis was done for the overall intention-to-treat (ITT) population. The safety population included all participants who received at least one dose of study treatment and was analysed according to the treatment actually received. In this study, all participants received at least one dose of their randomly assigned intervention (ie, the ITT population is the same as the safety population). This trial is registered with ClinicalTrials.gov (NCT05614089).

FINDINGS:

Between March 1 and Dec 19, 2023, we assessed 426 children and young people for eligibility. Of these, 400 (94%) were randomly assigned to receive either glargine (n=199) or usual care (n=201). At 6 months, the mean time in very low range was 3·6% (SD 5·6) in the glargine group and 3·4% (4·3) in the usual care group. After adjustment for prespecified baseline covariates, the adjusted mean difference was 0·22% (97·5% CI -0·83 to 1·27, p=0·63). The mean time in target range was 40·5% (SD 18·4) for glargine and 38·1% (18·1) for usual care. The adjusted mean difference was 0·55% (97·5% CI -2·78 to 3·89, p=0·71). Serious adverse events (SAEs) were uncommon, with a total of six SAEs among five (3%) of 199 participants in the glargine group and 14 SAEs among 13 (6%) of 201 participants in the usual care group.

INTERPRETATION:

At 6 months, children and young people with type 1 diabetes living in low-resource settings randomly assigned to glargine had no evidence of effects on time in very low range and time in target range compared with those assigned to usual care.

FUNDING:

The Leona M. and Harry B. Helmsley Charitable Trust.

01 Jul 2025·DIABETES OBESITY & METABOLISM

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups—Sharing Canadian perspectives

Review

Author: Chu, L. ; Abitbol, A.

Abstract:

Background:

The rising cost of insulins are significantly impacting health care expenditure, thereby limiting access to treatment for more people affected by diabetes. Fear and misunderstanding of insulin therapy have worsened with the emergence of biosimilar insulins. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference.

Results:

There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty ™. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins.

Conclusion:

Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. Tailoring effective conversations to patient needs ensures the best possible therapeutic outcomes.

Plain Language Summary:

This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost‐effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials, comparative studies evaluating efficacy and safety and manufacturing quality control. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Health care providers are encouraged to stay up to date on the latest guidelines and recommendations regarding biosimilar insulin interchangeability to ensure safe and cost‐effective use of these products. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins. A summary of adults with diabetes from this registry showed 3.8% of individuals with T1D were prescribed Basaglar® before April 2023 compared to 12.0% after January 2024. For the T2D cohort, the use of basal biosimilar insulins, Basaglar® and Semglee®, similarly increased by approximately 10% and 2% after January 2024, respectively. The use of bolus biosimilar insulins also increased after January 2024 by approximately 28% in the T1D cohort and 60% in the T2D cohort using insulin therapy. Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. People living with diabetes must have access to safe and effective treatment options, and they should be able to obtain appropriate medications at an affordable price and in a fair and timely manner.

01 Feb 2025·The Journal of the Association of Physicians of India

Safety and Efficacy of Biosimilar Insulin Glargine (Basaglar) in Indian Patients with Type 2 Diabetes Mellitus: Results from a Multicenter, Open-Label, Single-Arm, Phase 4 Trial (ABEX)

Article

Author: Shah, Parag ; Arora, Rohit ; Bhattacharya, Indranil ; Shamanna, Paramesh ; Spaepen, Erik ; Brahme, Keyur ; Saboo, Banshi ; Desai, Piyush ; Khandelwal, Deepak

BACKGROUND:

Basaglar^®, a biosimilar of glargine, was approved in India for the treatment of diabetes in patients aged >2 years. The efficacy and safety of biosimilar insulin glargine (Basaglar) have been previously established in Phase 3 clinical trials, ELEMENT-1, -2, and -5. This study assessed the safety and efficacy of Basaglar in Indian patients with type 2 diabetes mellitus (T2DM).

MATERIALS AND METHODS:

This multicenter, open-label, single-arm, phase 4 trial included Indian patients with insulin-naïve T2DM with glycated hemoglobin A1c (HbA1c) ≥7.0 to <11.0% who were receiving ≥2 oral antihyperglycemic drugs and/or a glucagon-like peptide-1-receptor agonist. Patients received Basaglar once daily for 24 weeks, excluding 4 weeks of safety follow-up. The primary endpoint was the incidence of total hypoglycemic events [blood glucose (BG) ≤54 mg/dL (≤3.0 mmol/L)] at week 24.

RESULTS:

Of the 259 patients enrolled, 64.1% were males, had mean [standard deviation (SD)] age 52.1 (11.38) years, and had diabetes for mean (SD) 6.75 (5.16) years. The mean HbA1c (SD) levels significantly improved from baseline to week 24 [-1.03 (1.554); p <0.0001] and Basaglar titration doubled from baseline. Total hypoglycemic events were reported in 10 (3.86%), 7 (2.70%), and 4 (1.54%) patients during weeks 0-24, 0-12, and 12-24, respectively. Ten patients (3.90%) reported 12 adverse events (AE; 11 mild and moderate, one severe). One death, unrelated to Basaglar, was reported.

CONCLUSION:

Basaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM.

113

News (Medical) associated with Insulin Glargine(Boehringer Ingelheim)

24 Sep 2026

·www.biospace.com

U.S. Food and Drug Administration (FDA) approves Lilly’s Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection treatment for adults living with type 2 diabetes

Onswik is designed to reduce injections by over 300 per year versus once-daily basal insulin 1,2 With Onswik, Lilly's type 2 diabetes portfolio expands to include a once-weekly basal insulin, alongside existing treatment options across insulins, incretins, oral and injectable medications INDIANAPOLIS , Sept. 24, 2026 /PRNewswire/ -- Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes. Onswik is designed to deliver steady basal insulin levels over a full seven days. 2 "For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes." This is the fourth global approval for Onswik for adults with type 2 diabetes, following regulatory actions from the European Medicines Agency (EMA), Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The FDA approval is based on data from the QWINT Phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik in over 3,400 adults with type 2 diabetes. In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 (glargine) or insulin degludec U-100 (degludec). 2-6 In these clinical trials, Onswik demonstrated an overall safety pro to the daily basal insulins studied. 3-6 Onswik should not be used by people who have type 1 diabetes due to increased risk of severe hypoglycemia (low blood sugar). Common side effects of Onswik include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain. Please see Indication and Safety Summary below and full Prescribing Information and Patient Information . Around one in eight Americans live with diabetes, and most of them have type 2 diabetes. 7 Globally by 2030, over 510 million people are expected to live with the disease and 38 million of these are expected to use insulin. 8 Insulin remains an important treatment option for many people with type 2 diabetes who do not achieve glycemic goals with other therapies. The Onswik™ KwikPen ® will be available in the U.S. in the coming months in two concentrations: 500 units/mL (contains 1,500 units total) and 1,000 units/mL (contains 3,000 units total). For more information about Onswik, please visit . About Onswik (insulin efsitora alfa-gobe) Onswik (insulin efsitora alfa-gobe) is a once-weekly basal insulin injection, FDA approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Its approval is supported by the QWINT clinical trial program, which evaluated its safety and efficacy in over 3,400 adults with type 2 diabetes. Onswik is also approved by the European Medicines Agency (EMA), the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in Mexico and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with type 2 diabetes mellitus. About the QWINT clinical trial program The QWINT Phase 3 global clinical development program for insulin efsitora alfa-gobe (efsitora) in diabetes began in 2022 and enrolled over 3,400 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed-dosage escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks underwent additional weekly dosage adjustments as needed. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-2 (NCT05362058) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia (Czech Republic), Germany, Greece, Japan, Korea, Mexico and Puerto Rico to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. INDICATION AND SAFETY SUMMARY Onswik™ (ON-swihk) is a long-acting insulin that is used with diet and exercise to control high blood sugar in adults with type 2 diabetes mellitus. • Onswik should not be used by people who have type 1 diabetes mellitus. • It is not known if Onswik is safe and effective in children. Onswik™ KwikPen ® is available in 2 concentrations: U-500 and U-1,000 • U-500 (500 units/mL) prefilled pen can be injected in 5-unit increments and can deliver up to 400 units in a single injection. • U-1,000 (1,000 units/mL) prefilled pen can be injected in 10-unit increments and can deliver up to 800 units in a single injection. Warnings – Do not take Onswik if you: • are having an episode of low blood sugar (hypoglycemia) • have an allergy to insulin efsitora alfa-gobe or any of the ingredients in Onswik Do not share your Onswik KwikPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Onswik and other insulin products or injectable medicines used to treat diabetes. Pay close attention to how you select your Onswik dosage, which is different from other injectable diabetes medicines. Always make sure that you select the correct dosage of your Onswik KwikPen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen. Do not dial the maximum single dosage (400 units or 800 units) of your Onswik KwikPen, unless prescribed by your healthcare provider. Do not use a syringe to withdraw Onswik from your pen. Talk to your healthcare provider if you have any questions about how to correctly dose Onswik KwikPen. Onswik may cause serious side effects that can lead to death, including: • Low blood sugar (hypoglycemia). Signs and symptoms may include: dizziness or light-headedness, anxiety, irritability, mood change, confusion, shakiness, blurred vision, slurred speech, fast heartbeat, sweating, hunger, or headache. • Severe allergic reactions (whole body reaction). Stop using Onswik and get medical help right away if you have any of these signs or symptoms: rash over your whole body, fast heartbeat, trouble breathing, or sweating. • Low potassium in your blood (hypokalemia). • Heart failure. Taking diabetes pills called thiazolidinediones or TZDs with Onswik may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you have heart failure, it may get worse if you take TZDs with Onswik. Your healthcare provider should monitor you closely while you are taking TZDs with Onswik. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, sudden weight gain, swelling of your ankles or feet, or tiredness. Your healthcare provider may need to change or stop treatment with TZDs and Onswik. Your insulin dose may need to be changed because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, change in diet, illness, or other medicines you take. Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion. Common side effects The most common side effects of Onswik include: low blood sugar (hypoglycemia), allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain. These are not all the possible side effects of Onswik. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Before taking Onswik, tell your healthcare provider about all your medical conditions and medicines you take, including if you: have liver or kidney problems. take diabetes medicines called TZDs. have heart problems. If you have heart failure, it may get worse while you take TZDs with Onswik. are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Onswik may harm your unborn or breastfeeding baby. take prescription or over-the-counter medicines, vitamins, or herbal supplements. Before you start Onswik, talk to your healthcare provider about low blood sugar and how to manage it. How to take Read the Instructions for Use that come with your Onswik KwikPen. Your healthcare provider should show you how to use Onswik KwikPen before you use it for the first time. Take Onswik exactly as your healthcare provider tells you. Know the type, strength and amount of insulin you take. Do not change the type of insulin unless your healthcare provider tells you to. Inject Onswik 1 time each week, on the same day of the week. If you need to change the day of the week, you may do so at least 4 days since your last dose. Then continue to inject Onswik 1 time each week on the new day you have chosen. If you miss a dose of Onswik, take the missed dose as soon as possible within 4 days (96 hours) after the missed dose, then continue your regular weekly dose schedule. If more than 4 days have passed, skip the missed dose and take your next dose on the regularly scheduled day or take the missed dose then change your regular weekly dose schedule to start 1 week after your missed dose was injected. If you accidentally take your 1-time starting dose more than 1 time (2 times in a row) or take your weekly dose more than 1 time in the same week, skip your next week's dose. Inject Onswik under the skin (subcutaneously) of your stomach area, buttocks, thigh or back of the upper arms. Do not use Onswik in an insulin pump or inject Onswik into your vein or muscle. Change (rotate) your injection sites within the area you choose with each dose. Do not use the exact same spot for each injection. Do not inject into skin that is thickened or has pits or lumps. Do not inject into skin that is tender, bruised, scaly, or hard or into scars or damaged skin. Always use a new needle for each injection. If your needle is blocked, get a new needle. Do not reuse or share your needles with other people. Do not use a syringe to remove the solution from the pen. Do not dilute or mix Onswik with another insulin or liquid medicine. Check your blood sugar levels. Ask your healthcare provider what your blood sugar levels should be and when you should check your blood sugar levels. While taking Onswik, do not: drive or operate heavy machinery, until you know how Onswik affects you. drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Learn more Onswik is a prescription medicine available as a 500 units/mL or 1,000 units/mL injection in a 3 mL pre-filled, single-patient-use pen. For more information, call 1-800-545-5979 or go to onswik.lilly.com . This summary provides basic information about Onswik but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Onswik and how to take it. Your doctor is the best person to help you decide if Onswik is right for you. EF CON BS SEP2026 Onswik™ is a trademark and KwikPen ® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Endnotes and References Based on approximate number of injections per year for Onswik (52 injections) vs a once-daily basal insulin (365 injections). This information is not intended to make a comparison of safety or efficacy. Onswik. Prescribing Information. Lilly USA, LLC. Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. N Engl J Med . 2025;393(4)(Incl suppl append):325-335. doi:10.1056/NEJMoa2502796 Wysham C, Bajaj HS, Del Prato S, et al. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. N Engl J Med . 2024;391(23)(Incl suppl mat):2201-2211. doi:10.1056/NEJMoa2403953 Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet . 2025;405(10497)(Incl suppl mat):2279-2289. doi:10.1016/S0140-6736(25)01044-X Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet . 2025;405(10497):2290-2301. doi:10.1016/S0140-6736(25)01069-4 Centers for Disease Control and Prevention. About type 2 diabetes. CDC. Accessed August 10, 2026. Basu S, Yudkin JS, Kehlenbrink S, et al. Estimation of global insulin use for type 2 diabetes, 2018–30: a microsimulation analysis. Lancet Diabetes Endocrinol. 2019;7(1):25-33. doi:10.1016/S2213-8587(18)30303-6. Available from: About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram , and LinkedIn . P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Onswik as a treatment for adults with type 2 diabetes and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that Onswik will receive additional regulatory approvals, or that Onswik will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. CMAT-49583 09/2026 ©Lilly USA, LLC 2026. All rights reserved. Refer to: Rachel Sorvig; sorvig_rachel@lilly.com (Media) Michael Czapar; czapar_michael_c@lilly.com (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company

Phase 3Clinical ResultDrug Approval

24 Sep 2026

·www.biospace.com

Eli Lilly’s weekly insulin shot cleared by FDA, setting up another front in Novo rivalry

iStock, Tingting Ji The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan. Eli Lilly’s weekly insulin, which offers a chance for patients with type 2 diabetes to receive more than 300 fewer injections per year, has been approved in the U.S. The FDA nod sets up yet another market battle between Lilly and obesity rival Novo. Insulin efsitora alfa-gobe will now be known as Onswik after the FDA approval, Lilly said in a Thursday press release . The FDA nod marks the fourth global approval for Onswik, which has already been cleared for use in Europe, Mexico and Japan. Onswik was tested in 3,400 adults in the Phase 3 QWINT clinical trials , which showed non-inferiority to standard once-daily options: insulin glargine, variations of which are sold by several Big Pharmas, or insulin degludec, marketed by Novo as Tresiba. In the QWINT-2 trial, Onswik lowered A1C, a measure of average blood sugar levels, by 1.34%, compared with a 1.26% reduction in patients that took degludec. These results were presented by Lilly at the Annual Meeting of European Association for the Study of Diabetes in September 2024 FDA Lilly joins Novo in cardiovascular space after FDA nod for GLP-1/GIP agonist Mounjaro With the approval, Eli Lilly’s Mounjaro becomes the first dual GIP/GLP-1 receptor agonist indicated to lower the risk of heart attack, stroke or cardiovascular death in adults with type 2 diabetes. August 28, 2026 · 2 min read · Heather McKenzie Read more Lilly promised that Onswik will be made available in the U.S. “in the coming months.” With the approval, Lilly has added another product to compete with Novo, which received FDA clearance for the once-weekly insulin Awiqli in March . The regulatory greenlight followed two FDA rejections in 2024, with the agency objecting to Novo’s request for approval in type 1 diabetes while also raising concerns about the manufacturing process for the drug. Novo refiled the application in September 2025 seeking a type 2 indication. With its approval earlier this year, the drug became the first once-weekly insulin medicine available in the U.S. On Onswik’s new label, Lilly stated that the drug should not be used in patients with type 1 diabetes due to an increased risk of low blood sugar. Awiqli’s label has warnings about using the drug with low blood sugar.

Drug ApprovalPhase 3Clinical Result

21 Aug 2026

·www.pharmaceutical-technology.com

Eli Lilly’s weekly insulin jab Onswik set for NHS use if approved

The jab’s availability will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. Credit: Halfpoint/Shutterstock.com. The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Eli Lilly’s Onswik (efsitora alfa) in a move that opens the insulin jab up for national coverage, subject to marketing authorisation. Lilly’s Onswik is a pre-filled injection pen containing insulin that only needs administering once a week. Its availability marks a big advancement for type 2 diabetic patients who rely on daily insulin injections, with initial forecasts that a switch to Lilly’s product could cut the number of injections each patient needs by 85%. It will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. While the recommendation means Onswik will be covered on England’s National Health Service (NHS), an approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) still needs to arrive first for the product to be available. A UK marketing authorisation is largely expected given the pre-emptive NICE recommendation. Onswik already secured a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2026, signifying a welcome sentiment with regulators so far. NICE based its decision on data from Lilly’s Phase III QWINT programme. Results demonstrated that Onswik controls blood glucose levels as well as two widely used long-acting insulins, insulin degludec and insulin glargine, which are taken to keep blood sugar steady throughout the day. It means people switching to the weekly injection can expect similar blood glucose control to their current treatment, NICE said. Type 2 diabetes is a common condition where the body cannot make enough of a hormone called insulin, or the insulin it makes does not work properly. Administering insulin helps the body better regulate glycaemic levels. Helen Knight, director of medicines evaluation at NICE, said: “Moving from daily injections to a single weekly dose could make a real difference to the day-to-day lives of people with type 2 diabetes, especially those who rely on a carer, family member or healthcare professional to help them inject. This recommendation is the result of rigorous, evidence-based decision making, striking a balance between the benefits to patients and the best use of limited NHS funding.” The relatively straightforward decision for Onswik contrasts a rockier UK reimbursement journey for Lilly’s Alzheimer’s therapy Kisunla (donanemab). In June 2025, NICE rejected NHS use of the drug based on the narrow window of clinical benefits. Lilly appealed the decision, with NICE referring the review back to its appraisal committee in March 2026. The UK’s reimbursement landscape has caused friction with other drugmakers recently. Bristol Myers Squibb (BMS) aligned UK and US prices for schizophrenia treatment Cobenfy, even threatening to walk away from the UK market if NICE did not recognise the drug’s clinical value. Separately, AstraZeneca and MSD have previously halted investment for UK expansion plans in the past year, criticising an unwelcoming and uncompetitive pharmaceutical environment. Given the size of the patient population for insulin products, NICE’s nod for Onswik will be a welcome one for drugmakers. Regardless, insulin represents a product that is far more accessible in the UK than the US. According to research , US prices for insulin products were nearly ten times as high as prices in 33 OECD comparison countries in 2022. The history of insulin coverage in the US has been dominated by complex rebate systems and a prevalence of pharmacy benefit managers.

Phase 3Drug Approval

100 Deals associated with Insulin Glargine(Boehringer Ingelheim)

External Link

KEGG	Wiki	ATC	Drug Bank
D03250	Insulin Glargine(Boehringer Ingelheim)	A10AE04	DB00047

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	United States	Eli Lilly & Co.	16 Dec 2015
Diabetes Mellitus, Type 2	United States	Eli Lilly & Co.	16 Dec 2015
Diabetes Mellitus	European Union	Eli Lilly Nederland BV	09 Sep 2014
Diabetes Mellitus	Iceland	Eli Lilly Nederland BV	09 Sep 2014
Diabetes Mellitus	Liechtenstein	Eli Lilly Nederland BV	09 Sep 2014
Diabetes Mellitus	Norway	Eli Lilly Nederland BV	09 Sep 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04153981 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	304	Insulin Glargine	pkwesmknta = nffzbepabr orzlyebazh (sdhsxpbifs, lwgmkrzhbo - xhenbcljjo) View more	-	15 Feb 2024
NCT03338023 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 1	272	insulin lispro+LY2963016	isqioeoerb(lknejwlgrn) = vinpwdvtfw btxyebwbcb (ciprgoewxy, 0.07)	Similar	01 Oct 2021
				insulin lispro+insulin glargine	isqioeoerb(lknejwlgrn) = qldbdxgmfa btxyebwbcb (ciprgoewxy, 0.07)
NCT03338010 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	536	LY2963016	ecoaugyevh(mxsluhcpco) = clnrdagawj plxldifkit (tlutgkyzzw )	Non-inferior	01 Aug 2021
				insulin glargine	ecoaugyevh(mxsluhcpco) = byxuorxkyf plxldifkit (tlutgkyzzw )
NCT03338010 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	536	LY2963016 (LY2963016)	kjmznxpgev(dutnmlgtyp) = rujzdkjguy ratnhzgece (oajchbkdcr, 0.043) View more	-	25 May 2021
				Lantus® (Lantus®)	kjmznxpgev(dutnmlgtyp) = bjrggdnwoc ratnhzgece (oajchbkdcr, 0.062) View more
NCT03338023 (ABES, CTgov)	Phase 3	Diabetes Mellitus, Type 1	272	LY2963016+Insulin Lispro (LY2963016 + Insulin Lispro)	fxxldtimkw(gnhlncogym) = oxnouvfgbp gtcifqvpep (gybvwycwce, 0.071) View more	-	29 Mar 2021
				Lantus®+Insulin Lispro (Lantus® + Insulin Lispro)	fxxldtimkw(gnhlncogym) = zrghrwtewf gtcifqvpep (gybvwycwce, 0.071) View more
NCT03555305 (CTgov)	Phase 1	-	58	Insulin Glargine (0.5 U/kg Insulin Glargine)	itbwwpjekd(yzvtqlhfjp) = xkgmrhlxpq kvwrhaciwv (dzqbdawpwg, 31) View more	-	24 Nov 2020
				Lantus (0.5 U/kg Lantus)	itbwwpjekd(yzvtqlhfjp) = yiutvzgbdn kvwrhaciwv (dzqbdawpwg, 33) View more
NCT02302716 (ELEMENT 5, Pubmed \| Clin Drug Investig)	Phase 3	Diabetes Mellitus, Type 2	493	Lilly insulin glargine (LY IGlar)	mwthqpjvhw(ebyqemlure) = hqtcwulnqg byfwtfqqwg (hmvfrmlhsf )	Positive	01 Aug 2019
				Insulin glargine (IGlar)	mwthqpjvhw(ebyqemlure) = trzfrtrggb byfwtfqqwg (hmvfrmlhsf )
NCT02302716 (ELEMENT 5, Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 2	493	Insulin Glargine	pazkyblewk(klzcunvvtx) = iwqhtfgaxv fojxfvjaru (neyipexocj )	Similar	01 Feb 2019
				Lantus	pazkyblewk(klzcunvvtx) = aexnzooqdw fojxfvjaru (neyipexocj )
NCT02302716 (ELEMENT 5, CTgov)	Phase 3	Diabetes Mellitus, Type 2	493	LY2963016+Oral Antihyperglycemic Medication (LY2963016)	frqhbhzfmw(vorvnnydor) = xeinoqgaqi tlnwuchqot (fwzdiqizya, 0.066) View more	-	24 Oct 2017
				Oral Antihyperglycemic Medication+LANTUS® (LANTUS®)	frqhbhzfmw(vorvnnydor) = kfqlcajrko tlnwuchqot (fwzdiqizya, 0.067) View more
NCT01421459 (ELEMENT 2, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	756	LY2963016	sdffdfgjuh(ayvcvktbiy) = nqggpoigof umdcspomms (iwkbphjxsg )	Positive	01 Aug 2015
				insulin glargine	sdffdfgjuh(ayvcvktbiy) = qdoxnuxdam umdcspomms (iwkbphjxsg )

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