Basaglar (insulin glargine biosimilar) / Boehringer Ingelheim, Eli Lilly - LARVOL DELTA

Efficacy and safety of orforglipron vs placebo added to titrated insulin glargine in adults with long-standing type 2 diabetes: ACHIEVE-5 (EASD 2026) - P3 | "Supported by: Eli Lilly and Company Clinical Trial Registration Number: NCT06109311 Background and aims: The efficacy and safety of the daily oral, non-peptide GLP-1RA orforglipron (OFG) were assessed as add-on to insulin glargine with/without metformin and/or SGLT-2 inhibitors in adults with type 2 diabetes (T2D)... In patients with long-standing T2D, oral OFG compared with PBO, in addition to titrated basal insulin, improved glycaemic control and reduced bodyweight without increasing hypoglycaemia risk."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Effects of orforglipron versus insulin glargine on kidney outcomes in people with type 2 diabetes and high cardiovascular risk: results of the ACHIEVE-4 trial (EASD 2026) - P3 | "Materials and In ACHIEVE-4, participants with T2D (HbA1c 7.0%-10.5% [53-91 mmol/mol], BMI ≥25 kg/m 2 ), on stable treatment with 1-3 glucose lowering medications (metformin, sulfonylurea, and/or sodium-glucose co-transporter 2 inhibitor [SGLT- 2i]), with increased CV risk were randomized 1:1 to OFG maximum tolerated dose (up to 36 mg capsule/17.2 mg tablet) or titrated IGlar... In people with T2D and excess weight at high CV risk, OFG preserved eGFR, lowered albuminuria, and reduced risk of major kidney outcomes vs IGlar over 104 weeks. Similar effects were observed in those with high/very high KDIGO risk."

Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • CST3

The GLAR-1-RANGE study: non-inferiority of EVA insulin glargine (Glargivin®) versus Lantus® in adolescents with type 1 diabetes assessed by continuous glucose monitoring metrics (EASD 2026) - "In this single center study, adolescents with T1D, Glargivin® achieved non-inferior CGM-based glycemic control compared with reference insulin glargine, with comparable TBR, TAR, GMI, and safety profiles. These findings support Glargivin® as a clinically effective and well-tolerated biosimilar basal insulin option in adolescents with T1D."

Head-to-Head • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

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. (PubMed, Lancet Diabetes Endocrinol) - P4 | "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."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Severe Hyperglycemia with A Normal HbA1c: Unmasking Hb Raleigh as A Cause of HbA1c Discordance (ENDO 2026) - "Treatment history included metformin intolerance and progression to basal–bolus insulin therapy (Basaglar 36 units daily; lispro 4 units with meals plus sliding-scale correction). Clinicians should suspect hemoglobin variants when HbA1c does not correlate with glucose data. In patients with Hb Raleigh, HbA1c significantly underestimates glycemia, risking undertreatment of diabetes. CGM-based metrics should be the primary method of monitoring in such cases."

Discordant • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia • Gastroenterology • Hematological Disorders • Hypertension • Hypoglycemia • Metabolic Disorders • Nephrology • Obstructive Sleep Apnea • Pancreatitis • Renal Calculi • Renal Disease • Respiratory Diseases • Sleep Disorder • Type 2 Diabetes Mellitus

Initiation of the interchangeable biosimilar insulin glargine-yfgn among older adults. (PubMed, Am J Manag Care) - "Insulin glargine-yfgn use among older adults is low despite its cost-effectiveness. Overcoming barriers related to prescribing patterns, formulary placement and reimbursement challenges, and pharmacy channels could improve insulin glargine-yfgn adoption, reducing diabetes care costs."

Journal • Retrospective data • Diabetes • Metabolic Disorders

Insulins for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison chart: Some available insulins for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Acute Dip in eGFR in Patients Treated with Tirzepatide: A Post Hoc Analysis of Long-Term Clinical Trials of Tirzepatide Treatment (KIDNEY WEEK 2025) - "The SURMOUNT-1 3-year study recruited adults with obesity or overweight and prediabetes randomized 1:1:1:1 to TZP 5:10:15mg or placebo (PBO) for 176 weeks...Conclusion These post-hoc analyses indicate a more frequent incidence of a dip in Cr-eGFR in TZP-treated (compared to iGlar-treated) participants with T2D. Furthermore, the presence of an acute dip in Cr-eGFR with TZP treatment was not associated with a more pronounced decline in kidney function."

Clinical • Late-breaking abstract • Retrospective data • Genetic Disorders • Metabolic Disorders • Obesity

Insulin Glargine Utilization and Spending Before and After the First Biosimilar Insulin Glargine: A Real-World Data Study. (PubMed, J Gen Intern Med) - "Basaglar® release was associated with spending reductions that accelerated after Semglee® availability. Biosimilar availability was associated with increases in glargine users and users per fixed-dollar amount. This study provides supportive evidence for biosimilar adoption policies."

Journal • Real-world evidence • Diabetes • Metabolic Disorders

Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. (PubMed, Lancet Diabetes Endocrinol) - P3 | "Tirzepatide added to basal insulin improved glycaemic control and was generally well tolerated, providing evidence to support its potential therapeutic use in patients with type 2 diabetes in China."

Journal • P3 data • Diabetes • Infectious Disease • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

Use of Highly Concentrated U500 Insulin with Omnipod 5 in automated mode (ENDO 2025) - "In addition to the insulin she received from her pump, she also required ~140 units of subcutaneous Basaglar daily... U-500R proved to be safe and effective with Omnipod 5 AID. Further research is required to adapt the automated dosing algorithm to U-500R to reduce the risk of nocturnal hypoglycemia."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Presentation of Glucokinase-Maturity-Onset Diabetes of the Young (GCK-MODY 2) in Obesity and with Transient Autoantibodies in Children and Adolescents. (ENDO 2025) - "She was treated with Glyburide, Metformin, Basaglar, and Victoza. MODY diagnosis should be considered regardless of BMI. The presence of severe obesity in cases of GCK heterozygotes treatment with insulin sensitizers, insulin, and GLPs becomes necessary. After normalization of weight, no treatment is necessary except for weight control."

Clinical • Diabetes • Gene Therapies • Genetic Disorders • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

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. (PubMed, Lancet) - P3 | "Efsitora showed non-inferior HbA1c reductions and similar rates of combined clinically significant or severe hypoglycaemia versus glargine U100 in participants with type 2 diabetes treated with basal and prandial insulin. These findings show that efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes."

Head-to-Head • Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Insulin Glargine Biosimilar Prescribing and Cost Trends in the United Kingdom's Primary Care from 2020 to 2024. (PubMed, Pharmacy (Basel)) - "The introduction of biosimilars does not automatically result in altered prescribing practices, though we show that the most commonly prescribed iGlar was also the least expensive product at the end of the analysis period. At launch and for several years after, biosimilars failed to gain strong utilization, despite cost advantages, highlighting the need for active switching policies and prescriber engagement."

Journal • Diabetes • Metabolic Disorders

Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. (PubMed, N Engl J Med) - P3 | "In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora, administered in a fixed-dose regimen, was noninferior to once-daily glargine in reducing glycated hemoglobin levels. (Funded by Eli Lilly; ClinicalTrials.gov number, NCT05662332.)."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Mannkind Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

State Substitution Laws and Uptake of an Interchangeable Insulin Biosimilar. (PubMed, JAMA Health Forum) - "This retrospective cohort study using MarketScan commercial claims data examined fills for insulin glargine among users who were younger than 65 years and had fills for the insulin glargine Lantus (Sanofi) and its biosimilars, interchangeable insulin glargine-yfgn (Semglee [Mylan Pharmaceuticals]) and a noninterchangeable insulin glargine (Basaglar [Lilly]). Three restrictions had more pronounced associations with a lower uptake of insulin glargine-yfgn: enhanced physician notification (-8.15 pp; 95% CI, -12.49 to -3.81 pp; P < .001), refill notifications (-4.68 pp; 95% CI, -8.78 to -0.58 pp; P = .03), and patient notification (-3.52 pp; 95% CI, -8.44 to 1.40 pp; P = .16). In this cohort study, insulin users in states with less restrictive substitution laws were more likely to fill the biosimilar alternative to insulin glargine, underscoring the role of state regulations of substitution as an important determinant of biosimilar adoption and the need for reforms to..."

Journal • Retrospective data

FIRST CLINICAL REPORT OF THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM BOLUS CALCULATOR USE IN FREE LIVING ENVIRONMENT (ATTD 2025) - "The Lilly Tempo Smart Button enables Basaglar®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. Use of the IC was consistent across all meals and corrections.Conclusions The aggregate glucose data indicates increased usage of the IC over the 6-week period corresponds to greater trust in the IC recommendations, as a significant percentage of administered doses were within 10% of the IC's suggested dose. Aggregate data indicates meaningful improvement in glycemic outcomes with the Tempo Platform IC over this period."

Clinical • Diabetes • Metabolic Disorders

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups-Sharing Canadian perspectives. (PubMed, Diabetes Obes Metab) - "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,..."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

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). (PubMed, J Assoc Physicians India) - "Basaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM."

Journal • P4 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries. (PubMed, BMJ Open) - "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."

Journal • Retrospective data

Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth with Diabetes in Pakistan (clinicaltrials.gov) - P4 | N=296 | Completed | Sponsor: Life for a Child Program, Diabetes Australia

HEOR • New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh (clinicaltrials.gov) - P4 | N=202 | Completed | Sponsor: Life for a Child Program, Diabetes Australia

HEOR • New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali (clinicaltrials.gov) - P4 | N=260 | Completed | Sponsor: Life for a Child Program, Diabetes Australia

New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus