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 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.

01 Jan 2025·BMJ Open

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries

Article

Author: Morolla, Davide ; von Schoen-Angerer, Tido ; Ewen, Margaret ; Beran, David ; Raviglione, Mario

Objective:

Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country.

Methods:

Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its biosimilars. Segmented regression analysis using a dual-model approach: pooled and country-specific.

Setting:

28 European countries using data from the European Medicine Price Database for the period 2013–2023.

Main outcome measures:

Price variations between countries were analysed to assess trends and correlations before and after biosimilar market entry.

Results:

In the 28 countries studied, cost of insulin glargine underwent a median 21.6% decrease overall in the last decade (p<0.001). In 2022, the median price was €9.0 for the originator (first to market) Lantus (IQR €8.1–€10.4), €8.9 for the biosimilar Abasaglar (IQR €7.6–€10.1) and €7.0 for the biosimilar Semglee (median €7.0; IQR €6.8–€7.5). The originator price was higher than biosimilars (p=0.009). Biosimilar market entry was associated with an overall significant price reduction of the originator, both immediately after entry (p<0.001) and in the long-term postentry (p<0.001). No significant correlation was observed between the price of insulin and the countries’ economic indicators.

Conclusion:

This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers.

106

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

16 Apr 2026

·www.fiercepharma.com

Lilly answers FDA's call for more Foundayo safety info, plotting diabetes filing in parallel

With safety and efficacy successes in hand, Lilly says it will now submit Foundayo to the FDA for review in type 2 diabetes by the end of the second quarter. Eli Lilly is wasting no time in pursuit of the next indication for its newly christened obesity pill Foundayo, presenting new data in diabetes Thursday that also serve to address the FDA’s desire for more safety info on the oral GLP-1. The results seen with Foundayo, also known as orforglipron, enabled Lilly’s late-stage Achieve-4 study to hit its primary endpoint. Specifically, the drug demonstrated non-inferiority to insulin glargine in adults with Type 2 diabetes and obesity, or who are overweight, who are at increased cardiovascular risk. The risk of major adverse cardiovascular events (MACE)—including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest paint—was 16% lower in the trial’s Foundayo cohort compared to the insulin arm, Lilly said in an April 16 press release. Meanwhile, Foundayo also proved superior to insulin glargine at improving blood sugar levels and helping patients reduce body weight at the one-year mark, with those benefits persisting through 104 weeks of treatment, according to Lilly. With safety and efficacy successes in hand, the company says it will now submit the drug to the FDA for an approval verdict Type 2 diabetes by the end of the second quarter, with plans to once again leverage the new Commissioner’s National Priority Review Voucher program. That lower MACE risk for Foundayo, which was the study’s prime non-inferiority goal, may help appease the FDA’s desire for additional safety information on the drug, as laid out in the approval letter (PDF) for Foundayo issued at the top of the month, when it was greenlit in obesity. In that letter, the regulator called on Lilly specifically to accrue more data on the med’s potential link to MACE and drug-induced liver injury, plus further information about delayed gastric emptying associated with Foundayo, as well as its potential effects in lactating women. The agency singled out the Achieve-4 study as an appropriate vehicle to furnish the necessary MACE data. Lilly noted that while its trial didn’t control for multiplicity, the risk of all-cause death was “significantly lower” for patients on Foundayo versus insulin glargine, too. Moreover, the company said its study included a “thorough analysis of potential drug-induced liver injury,” with its analyses confirming “no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs.” Lilly boasted that Achieve-4 marks its “largest and longest study” of Foundayo for Type 2 diabetes thus far. The trial enrolled more than 2,700 patients across 15 countries. "Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile," Thomas Seck, M.D., SVP of product development for Lilly Cardiometabolic Health, said in a statement Thursday. He continued, “ACHIEVE-4 adds a new dimension to that evidence—cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk.”Aside from the lower MACE risk observed with Foundayo, Lilly’s med also showed clinically meaningful improvements from baseline on multiple cardiovascular risk factors, such as non-HDL cholesterol, systolic blood pressure, triglycerides and high-sensitivity C-reactive protein (hsCRP)—a marker of inflammation. Foundayo’s FDA nod on April 1 formalized the opening of a new front in the obesity and broader GLP-1 commercial contest playing out between Lilly and Novo Nordisk. Until now, that competition had been waged between the company’s respective injectables for diabetes and obesity: Mounjaro and Zepbound in Lilly’s case, and Ozempic and Wegovy for Novo. Novo got a leg up on Lilly with the approval of its own oral weight loss med, the Wegovy pill, at the tail end of 2025, which it followed up with a January 5 launch that has so far posted impressive results. Lilly is hoping the fact that its pill can be taken at any time of day and without food or water restrictions could give Foundayo a convenience edge over oral Wegovy, which must be taken on an empty stomach in the morning with up to 4 ounces of water, and not any other liquids.

Phase 3Clinical ResultPriority Review

16 Apr 2026

·www.prnewswire.com

ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health

In ACHIEVE-4, Foundayo met the primary objective of non-inferiority vs. insulin glargine with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events In a pre-planned analysis, the risk of all-cause death was 57% lower for Foundayo vs. insulin glargine, showing the potential for more comprehensive health benefits With these data, Lilly plans to submit Foundayo for the treatment of type 2 diabetes to the U.S. Food and Drug Administration by the end of Q2 INDIANAPOLIS, April 16, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo (orforglipron), compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk. ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes to date, enrolled more than 2,700 participants across 15 countries. In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. In addition, Foundayo showed superior improvements in A1C and body weight at 52 weeks vs. insulin glargine, which persisted through 104 weeks of therapy. While not controlled for multiplicity, the risk of all-cause death was significantly lower for Foundayo vs. insulin glargine. "Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "ACHIEVE-4 adds a new dimension to that evidence — cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes." In the trial, the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable sudden chest pain was 16% lower for Foundayo vs. insulin glargine (hazard ratio: 0.84; 95.0% CI: 0.59 to 1.20), meeting the prespecified criteria for demonstrating non-inferiority (upper limit of 95.0% CI of the hazard ratio < 1.8).1 The risk of all-cause death was 57% lower with Foundayo vs. insulin glargine (hazard ratio: 0.43; 95.0% CI: 0.25 to 0.75; nominal p = 0.002).2 Foundayo also showed clinically meaningful improvements from baseline across several cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, triglycerides, and hsCRP.2 ACHIEVE-4 Topline Results: The overall safety and tolerability profile of Foundayo in ACHIEVE-4 was generally consistent with previous trials and with the GLP-1 class. The most common adverse events for patients taking Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of patients taking Foundayo discontinued treatment due to adverse events. ACHIEVE-4 included a thorough analysis of potential drug-induced liver injury (DILI), and these analyses confirmed there was no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs. Lilly will submit Foundayo for the treatment of type 2 diabetes to the U.S. FDA by the end of the second quarter under the Commissioner's National Priority Review Voucher. About Foundayo (orforglipron) Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.4 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, Foundayo is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. About ACHIEVE-4 and ACHIEVE clinical trial program ACHIEVE-4 (NCT05803421) is a Phase 3, event-driven, randomized, open-label trial evaluating the efficacy and safety of Foundayo compared with insulin glargine in adults with type 2 diabetes and obesity or overweight (BMI ≥25 kg/m2) with increased risk of cardiovascular events. The trial randomized 2,749 participants across the U.S., Argentina, Austria, Brazil, Czechia, Germany, Greece, India, Italy, Mexico, Puerto Rico, Romania, Slovakia, South Korea, Spain and Turkey to receive either escalating doses of Foundayo or insulin glargine. The primary objective of the study was to demonstrate that Foundayo was non-inferior in the risk of major adverse cardiovascular events (MACE-4) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight with increased risk for cardiovascular events who have taken at least one and no more than three oral anti-diabetic medications for at least 90 days prior to study start. Study participants had an A1C between ≥7.0% and ≤10.5% (≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea) and a BMI of ≥25 kg/m2 with stable weight (±5%) for at least 90 days prior to study start. Participants randomized to Foundayo initiated treatment with 1 mg capsule (corresponds to 0.8 mg tablets) once daily and increased the dose every four weeks until reaching a maximum tolerated dose (up to 36 mg capsule/17.2 mg tablet). The ACHIEVE Phase 3 global clinical development program for Foundayo began in 2023 and enrolled more than 6,000 people with type 2 diabetes across five global registrational trials. Endnotes and References Time to first event analysis using Cox proportional hazard model using all randomized participants exposed to ≥1 dose of study intervention. All-cause death, serum lipids, blood pressure, and hsCRP were not controlled for family-wise type 1 error. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions) without initiating additional antihyperglycemic medications (>14 days of use). Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. . Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. (2020) INDICATION AND SAFETY SUMMARY WITH WARNINGS Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery. Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before taking Foundayo Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ Do you have a history of diabetic retinopathy? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby. ❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo. ❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com. This summary provides basic information about Foundayo 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 Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026 Foundayo™ is a trademark of Eli Lilly and Company. 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 nearly 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 Foundayo (orforglipron) as a potential treatment for adults with type 2 diabetes, potential efficacy and tolerability of Foundayo, and the timeline for future readouts, presentations, and other milestones relating to Foundayo and its clinical trials 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 planned or ongoing studies will be completed as planned, that future study results will be consistent with expectations or study results to date, that Foundayo will prove to be a safe and effective treatment for type 2 diabetes or other potential indications, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. 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. # # # Refer to: Niki Biro; [email protected]; 317-358-9074 (Media) Michael Czapar; [email protected]; 317-617-0983 (Investors) SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Phase 3Clinical ResultPriority Review

16 Apr 2026

·endpoints.news

Lilly's obesity pill heads for diabetes filing after heart risk trial

Eli Lilly’s recently approved obesity pill Foundayo cut the risk of cardiovascular events like heart attack and stroke by 16% versus a form of insulin, new data show, and the company is planning to file the drug in diabetes as a result. Perhaps as importantly, the study found no sign of hepatic toxicity. In its approval letter for Foundayo, the FDA had requested data on drug-induced liver injury from this trial called ACHIEVE-4. “ACHIEVE-4 included a thorough analysis of potential drug-induced liver injury (DILI), and these analyses confirmed there was no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs,” Lilly said Thursday. In the study, Foundayo was only non-inferior to the insulin, which was Lilly’s own product called Basaglar. The trial met the primary endpoint of showing Foundayo to be noninferior to Basaglar in reducing the risk of major adverse cardiovascular events (MACE-4). The study enrolled patients with both obesity and diabetes who were at increased cardiovascular risk. The data are the latest move in the battle between Lilly and Novo Nordisk for the metabolic disease market. Novo already has a GLP-1 pill to treat diabetes — Rybelsus has been on the market since 2019 — so Lilly is playing catch-up.

100 Deals associated with Insulin Glargine(Boehringer Ingelheim)

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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	edagksdgrs = tvbpxabpqv sudejkcggt (oauraxekyq, hbrqtcmxjx - fectdbhuhs) View more	-	15 Feb 2024
NCT03338023 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 1	272	insulin lispro+LY2963016	khgifmjwur(leymnmltsr) = qthxdpjjvn hgmqewwsev (lxdhuqtzaw, 0.07)	Similar	01 Oct 2021
				insulin lispro+insulin glargine	khgifmjwur(leymnmltsr) = piizvvshsg hgmqewwsev (lxdhuqtzaw, 0.07)
NCT03338010 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	536	LY2963016	nncocdjfwe(mlckypbttx) = kydglowwcb iwbeylnhms (cnollftdum )	Non-inferior	01 Aug 2021
				insulin glargine	nncocdjfwe(mlckypbttx) = anreztxxah iwbeylnhms (cnollftdum )
NCT03338010 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	536	LY2963016 (LY2963016)	sxtpspvvsy(fdgvvkexzr) = qtysxargfg rkwnnrtsiu (hwrcidgnca, 0.043) View more	-	25 May 2021
				Lantus® (Lantus®)	sxtpspvvsy(fdgvvkexzr) = owjiwcjbpm rkwnnrtsiu (hwrcidgnca, 0.062) View more
NCT03338023 (ABES, CTgov)	Phase 3	Diabetes Mellitus, Type 1	272	LY2963016+Insulin Lispro (LY2963016 + Insulin Lispro)	ppwoqwfwks(jzwijgxjzp) = tzhasetymu ttexilchsr (hvxzibtfmf, 0.071) View more	-	29 Mar 2021
				Lantus®+Insulin Lispro (Lantus® + Insulin Lispro)	ppwoqwfwks(jzwijgxjzp) = onyrnstkxp ttexilchsr (hvxzibtfmf, 0.071) View more
NCT03555305 (CTgov)	Phase 1	-	58	Insulin Glargine (0.5 U/kg Insulin Glargine)	eliibknbgy(vrgdjljcei) = chrloefofi asnrvaopvt (sppjvzplay, 31) View more	-	24 Nov 2020
				Lantus (0.5 U/kg Lantus)	eliibknbgy(vrgdjljcei) = dkbdyhjzdp asnrvaopvt (sppjvzplay, 33) View more
NCT02302716 (ELEMENT 5, Pubmed \| Clin Drug Investig)	Phase 3	Diabetes Mellitus, Type 2	493	Lilly insulin glargine (LY IGlar)	rcbghvgucg(bhbucgppsr) = afzufzpmrc qyzcdwbgnj (pyolpomjkw )	Positive	01 Aug 2019
				Insulin glargine (IGlar)	rcbghvgucg(bhbucgppsr) = akgborihao qyzcdwbgnj (pyolpomjkw )
NCT02302716 (ELEMENT 5, Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 2	493	Insulin Glargine	tbhlnsajbf(hyzhosnunt) = yoalpeyuco atfwnqnlyc (xmrinerrle )	Similar	01 Feb 2019
				Lantus	tbhlnsajbf(hyzhosnunt) = bmrfkeconm atfwnqnlyc (xmrinerrle )
NCT02302716 (ELEMENT 5, CTgov)	Phase 3	Diabetes Mellitus, Type 2	493	LY2963016+Oral Antihyperglycemic Medication (LY2963016)	ekzwqeqbjv(hwqwmwmxcy) = wwuavcghbm tmsbbvmpyl (lncxwisdme, 0.066) View more	-	24 Oct 2017
				Oral Antihyperglycemic Medication+LANTUS® (LANTUS®)	ekzwqeqbjv(hwqwmwmxcy) = phsmuildow tmsbbvmpyl (lncxwisdme, 0.067) View more
NCT01421459 (ELEMENT 2, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	756	LY2963016	awglihungf(vcwzstiieq) = btsxthwzua mtlowaqlug (kucjhgyvxv )	Positive	01 Aug 2015
				insulin glargine	awglihungf(vcwzstiieq) = wnnaknclaz mtlowaqlug (kucjhgyvxv )

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