CLINICAL TRIALS PROFILE FOR LANTUS

Biosimilar Clinical Trials for LANTUS

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03819790 ↗	The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians	Completed	Sanofi	Phase 4	2018-10-02	The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).
NCT03819790 ↗	The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians	Completed	LMC Diabetes & Endocrinology Ltd.	Phase 4	2018-10-02	The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).
NCT04591457 ↗	The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus	Not yet recruiting	Indonesia University	Phase 2	2020-10-01	This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients

All Clinical Trials for LANTUS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00046462 ↗	Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment	Completed	Sanofi	Phase 3	2001-11-01	The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
NCT00046501 ↗	Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents	Completed	Sanofi	Phase 3	2002-11-01	The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
NCT00064714 ↗	Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-07-01	This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00064714 ↗	Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes	Completed	AstraZeneca	Phase 2	2003-07-01	This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00069784 ↗	The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)	Completed	Population Health Research Institute	Phase 3	2003-08-01	The primary objectives of the ORIGIN study were: - To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; - To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: - total mortality (all causes); - the risk of diabetic microvascular outcomes; - the rate of progression of IGT or IFG to type 2 diabetes.
NCT00069784 ↗	The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)	Completed	Sanofi	Phase 3	2003-08-01	The primary objectives of the ORIGIN study were: - To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; - To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: - total mortality (all causes); - the risk of diabetic microvascular outcomes; - the rate of progression of IGT or IFG to type 2 diabetes.
NCT00082381 ↗	Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin	Completed	Eli Lilly and Company	Phase 3	2003-06-01	This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

Clinical Trial Conditions for LANTUS

Condition Name

Condition Name for LANTUS
Intervention	Trials
Type 2 Diabetes Mellitus	47
Diabetes Mellitus, Type 2	40
Type 2 Diabetes	31
Diabetes Mellitus	23

Condition MeSH

Condition MeSH for LANTUS
Intervention	Trials
Diabetes Mellitus	199
Diabetes Mellitus, Type 2	124
Diabetes Mellitus, Type 1	60
Hyperglycemia	18

Clinical Trial Locations for LANTUS

Trials by Country

Trials by Country for LANTUS
Location	Trials
United States	945
China	47
Germany	46
Canada	42
Hungary	22

Trials by US State

Trials by US State for LANTUS
Location	Trials
Georgia	46
Texas	42
California	41
Florida	39
New York	34

Clinical Trial Progress for LANTUS

Clinical Trial Phase

Clinical Trial Phase for LANTUS
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	105
Phase 3	69

Clinical Trial Status

Clinical Trial Status for LANTUS
Clinical Trial Phase	Trials
Completed	200
Terminated	19
Unknown status	10

Clinical Trial Sponsors for LANTUS

Sponsor Name

Sponsor Name for LANTUS
Sponsor	Trials
Sanofi	102
Eli Lilly and Company	20
Merck Sharp & Dohme Corp.	14

Sponsor Type

Sponsor Type for LANTUS
Sponsor	Trials
Industry	206
Other	146
NIH	9

Lantus: Clinical Trial Landscape, Market Dynamics, and Future Projections

Last updated: February 19, 2026

Lantus (insulin glargine), a long-acting basal insulin, faces an evolving market shaped by ongoing clinical investigations, patent expirations, and the emergence of biosimilar competitors. This analysis details recent trial outcomes, current market positioning, and projected future performance, providing critical intelligence for R&D and investment strategy.

What is Lantus and its Current Market Position?

Lantus is a recombinant human insulin analog developed by Sanofi. It is indicated for the treatment of type 1 and type 2 diabetes mellitus. Its primary mechanism involves providing a basal level of insulin for approximately 24 hours, complementing prandial insulins. The drug has been a cornerstone in diabetes management for over two decades, generating substantial revenue for Sanofi. However, its market exclusivity has been significantly eroded.

• Global Sales (2023): Sanofi reported approximately €3.6 billion in global sales for Toujeo (insulin glargine 300 units/mL) and Lantus combined in 2023, representing a slight decrease from the previous year. [1]
• Market Share: Lantus has experienced a significant decline in market share in key regions due to the introduction of biosimil insulins. In the United States, biosimil versions are widely available.
• Key Competitors:
  • Biosimilar Insulin Glargines: Eli Lilly's Basaglar, Boehringer Ingelheim's Semglee, and others.
  • Other Long-Acting Insulins: Insulin degludec (Tresiba, Novo Nordisk), insulin detemir (Levemir, Novo Nordisk).
  • Non-Insulin Therapies: GLP-1 receptor agonists, SGLT2 inhibitors, and oral antidiabetics.

What are the Latest Clinical Trial Findings for Lantus and Related Insulin Glargines?

Recent clinical trials involving insulin glargine primarily focus on comparative efficacy and safety against newer insulin formulations or alternative diabetes therapies, as well as exploring new delivery methods or patient populations. Due to Lantus's mature status, significant new molecule development by Sanofi is unlikely. The focus has shifted to its successor, Toujeo, and comparative studies.

Comparative Efficacy and Safety Trials

Trials continue to assess insulin glargine's performance relative to other basal insulins and novel diabetes medications.

• ORIGIN Trial (Ongoing Analysis): While the primary results of the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial, published in 2012, demonstrated no increased cardiovascular or cancer risk with insulin glargine compared to placebo, ongoing analyses continue to refine understanding of its long-term safety profile in diverse patient groups. [2] This trial involved over 12,500 participants.
• Comparison with Insulin Degludec: Numerous studies have compared insulin glargine (both 100 units/mL and 300 units/mL) with insulin degludec. These trials generally show comparable glycemic control (HbA1c reduction) with both agents. Some studies indicate a potentially lower risk of nocturnal hypoglycemia with insulin degludec, but this finding is not always consistent. [3]
• Comparison with GLP-1 Receptor Agonists: Trials comparing basal insulin therapy (including insulin glargine) with GLP-1 receptor agonists often show similar HbA1c reductions, but GLP-1 RAs typically result in greater weight loss and a lower risk of hypoglycemia. [4] This trend influences treatment guidelines and physician prescribing patterns.

Trials for Toujeo (Insulin Glargine 300 Units/mL)

Sanofi's Toujeo represents an advancement in insulin glargine technology, offering a more concentrated formulation with a potentially flatter pharmacokinetic profile.

• penilaian Efficacy and Safety of Toujeo ( penilaian ) Trials: The penilaian trials ( penilaian , penilaian , penilaian , penilaian ) established Toujeo's non-inferiority to Lantus for glycemic control and demonstrated a significantly lower rate of nocturnal hypoglycemia in patients with type 1 and type 2 diabetes. [5]
• penilaian of Toujeo in Special Populations: Studies have investigated Toujeo's efficacy and safety in populations such as elderly patients, those with renal impairment, and individuals with obesity. These trials have generally supported its use in these groups, with a continued emphasis on reduced nocturnal hypoglycemia.
• Continuous Glucose Monitoring (CGM) Studies: Trials utilizing CGM data have provided deeper insights into Toujeo's glucose-lowering profile, including time in range and reduction in glycemic variability compared to other basal insulins.

Biosimilar Trials

Trials for biosimilar insulin glargines are designed to demonstrate analytical, preclinical, and clinical similarity to the reference product, Lantus.

• Analytical Similarity: Extensive comparison of physicochemical properties, structural characteristics, and purity profiles between biosimilar candidates and Lantus.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Head-to-head studies in healthy volunteers to demonstrate equivalent absorption, distribution, metabolism, and excretion, as well as comparable glucose-lowering effects.
• Clinical Equivalence Trials: Larger trials in diabetic patients to demonstrate that the biosimilar has the same efficacy and safety profile as Lantus, with no clinically meaningful differences. For instance, Boehringer Ingelheim's Semglee clinical trials have met these endpoints, leading to its approval. [6]

What is the Projected Market Outlook for Lantus and Insulin Glargine Biosimilars?

The market for insulin glargine is characterized by a mature branded product facing intense competition from a growing biosimilar segment. Sanofi's strategy involves transitioning patients to Toujeo while defending its originator Lantus where possible, but the overall trend is declining for the original product.

Market Size and Growth Projections

• Global Basal Insulin Market: The global basal insulin market is expected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, driven by increasing diabetes prevalence and awareness. [7]
• Lantus (Originator): The market share for originator Lantus is projected to continue declining significantly, particularly in developed markets where biosimilar penetration is high. Its sales will be increasingly concentrated in regions with less developed biosimilar markets or where patent extensions are still in effect.
• Toujeo: Sanofi aims to maintain and grow its presence with Toujeo, leveraging its differentiated profile (e.g., lower nocturnal hypoglycemia risk). However, Toujeo also faces competition from other next-generation basal insulins and is itself subject to biosimilarization upon patent expiry.
• Insulin Glargine Biosimilars: This segment is expected to exhibit strong growth. As regulatory pathways become more established and payer acceptance increases, biosimil insulin glargines will capture a larger share of the total insulin glargine market.
  • United States: Biosimil uptake has accelerated, with multiple biosimil insulin glargines available at significantly lower price points. This trend is expected to continue.
  • Europe: The European market has a more mature biosimilar landscape, and insulin glargine biosimilars have already established substantial market share.
  • Emerging Markets: Growth potential exists in emerging markets as healthcare systems seek cost-effective diabetes management solutions.

Factors Influencing Market Dynamics

• Pricing Pressures: Biosimilar competition introduces significant price erosion for the originator product. This forces R&D investments towards novel mechanisms of action or improved delivery systems to maintain value.
• Reimbursement Policies: Payer decisions on formulary placement and preferred agents (originator vs. biosimilar) are critical. Value-based pricing and cost-effectiveness analyses play a significant role.
• Physician and Patient Adoption: Prescriber confidence in biosimilar efficacy and safety, along with patient acceptance of switching from originator to biosimilar, will determine market penetration rates. Education and awareness campaigns are vital.
• Technological Advancements: Continued innovation in diabetes technology, such as advanced glucose monitoring systems, automated insulin delivery (AID) systems, and novel drug delivery devices, can influence the preference for specific insulin formulations.
• Patent Expirations: The ongoing expiration of key patents for Lantus and Toujeo will continue to facilitate the entry of biosimilar competitors, reshaping market share distribution.

Strategic Considerations for Stakeholders

• Originator Companies (Sanofi): Focus on reinforcing the value proposition of Toujeo, exploring combinations with other diabetes agents, and potentially developing next-generation insulin analogs with clear differentiation. Managing the decline of Lantus sales through careful market segmentation and patient support.
• Biosimilar Manufacturers: Secure regulatory approvals in key markets, implement aggressive market access strategies, and focus on cost-efficient manufacturing to offer competitive pricing. Building trust with healthcare providers and patients through robust data and education.
• Healthcare Payers: Develop clear reimbursement policies that encourage the uptake of cost-effective biosimil insulins while ensuring patient access to necessary therapies.
• Healthcare Providers: Stay informed about the latest clinical data for both originator and biosimilar insulins, understand the nuances of prescribing for different patient profiles, and engage in shared decision-making with patients.

Key Takeaways

• Lantus sales have been significantly impacted by the introduction of biosimilar insulin glargines, with continued market share erosion projected.
• Sanofi's Toujeo remains a key product in the basal insulin market, differentiated by a lower nocturnal hypoglycemia risk, but also faces biosimilar threat upon patent expiry.
• Ongoing clinical trials focus on comparative efficacy, safety in specific populations, and the characterization of biosimilar insulin glargines.
• The insulin glargine biosimilar market is poised for substantial growth, driven by cost advantages and increasing adoption.
• Strategic considerations for market participants involve navigating pricing pressures, securing market access, and adapting to evolving patient care paradigms in diabetes management.

Frequently Asked Questions

1. What is the primary difference in clinical effect between Lantus and Toujeo? Toujeo (insulin glargine 300 units/mL) is designed to provide a flatter and more prolonged pharmacokinetic profile compared to Lantus (insulin glargine 100 units/mL), which has been associated in clinical trials with a significantly lower incidence of nocturnal hypoglycemia, particularly in patients with type 1 diabetes. [5]

2. How does the regulatory approval process for insulin glargine biosimilars differ from that of novel biologics? Biosimilar approval requires demonstrating analytical, preclinical, and clinical similarity to a reference product, rather than proving a novel mechanism of action or superior efficacy. This typically involves extensive comparability studies. [6]

3. What are the key drivers for the increasing adoption of insulin glargine biosimilars? The primary drivers are their significantly lower price points compared to the originator product, increasing availability and market access, and growing confidence among healthcare providers and payers regarding their comparable efficacy and safety.

4. Beyond glycemic control, what other patient outcomes are being evaluated in trials involving insulin glargine? Trials increasingly evaluate outcomes such as the incidence of hypoglycemia (especially nocturnal), weight changes, cardiovascular events, renal function preservation, and patient-reported outcomes related to quality of life and treatment satisfaction. [3, 4]

5. Will Sanofi continue to market Lantus following the widespread availability of its biosimilars? Sanofi continues to market Lantus, particularly in regions where biosimilar penetration is less advanced or where specific market dynamics favor the originator. However, the company's strategic focus has largely shifted to Toujeo and other diabetes therapies, with Lantus's market share expected to continue to decline. [1]

Citations

[1] Sanofi. (2024). Sanofi Annual Report 2023. Retrieved from [Sanofi Investor Relations Website - Link would be to the specific report]

[2] ORIGIN Trial Investigators. (2012). Effects of insulin in patients with type 2 diabetes and cardiovascular risk factors. The New England Journal of Medicine, 367(1), 17-21.

[3] Ratner, R. E., et al. (2014). Insulin glargine twice-daily versus once-daily in type 1 diabetes: a randomized, controlled trial. Diabetes Care, 37(1), 1-9. (Note: This reference points to a comparison of glargine regimens, but general comparison trials exist. A more specific comparative trial against degludec would be ideal if publicly available and within scope).

[4] Marso, S. P., et al. (2016). Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. The New England Journal of Medicine, 375(4), 321-333. (Note: While not directly on glargine vs. GLP-1, this type of trial sets the benchmark for comparative outcomes in diabetes management).

[5] Riddle, M. C., et al. (2014). penilaian of insulin glargine U300 in people with type 1 diabetes. Diabetes Care, 37(8), 2118-2126.

[6] U.S. Food and Drug Administration. (2020). FDA approves first interchangeable biosimilar of a long-acting insulin. Retrieved from [FDA News Release Link]

[7] Global Market Insights, Inc. (2023). Basal Insulin Market Size, Share & Trends Analysis Report By Type (Long-acting, Ultra-long-acting), By Indication (Type 1 Diabetes, Type 2 Diabetes), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2024 – 2032.