CLINICAL TRIALS PROFILE FOR LANTUS

505(b)(2) Clinical Trials for Lantus

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00151697 ↗	LANN-study: Lantus, Amaryl, Novorapid, Novomix Study	Completed	Rijnstate Hospital	Phase 3	2005-05-01	Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
New Formulation	NCT01349855 ↗	Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus	Completed	Sanofi	Phase 1	2011-03-01	Primary Objective: To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen Secondary Objective: To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
New Formulation	NCT01493115 ↗	Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus	Completed	Sanofi	Phase 1	2011-11-01	Primary Objective: To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® Secondary Objective: To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation
New Formulation	NCT01499082 ↗	Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin	Completed	Sanofi	Phase 3	2011-12-01	Primary Objective: - To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus Secondary Objectives: - To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

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.

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
Emory University	14

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Lantus

Last updated: October 28, 2025

Introduction

Lantus (insulin glargine) has been a cornerstone in the treatment of diabetes mellitus, particularly Type 1 and Type 2 insulin-dependent diabetes. Launched by Sanofi in 2000, Lantus marked a significant advancement as a long-acting basal insulin with a duration of action extending over 24 hours. Despite its therapeutic success, recent developments, clinical trial updates, and evolving market dynamics necessitate a comprehensive review to inform stakeholders’ strategic decisions.

---

Clinical Trials Update

Recent and Ongoing Clinical Trials

Lantus’s clinical development landscape has largely shifted towards biosimilar competition and combination therapies, but ongoing research remains relevant. Notably:

• Biosimilar Development: Multiple biosimilars to Lantus, such as Basaglar (Eli Lilly) and Semglee (Mylan/Biocon), have received regulatory approval, influencing Lantus’s market share. To maintain efficacy standards, biosimilars undergo extensive biosimilarity trials, including pharmacokinetic and pharmacodynamic assessments, confirming therapeutic equivalence with the originator [1].

• Safety and Efficacy Trials: Phase 4 studies continue to monitor long-term safety profiles, focusing on hypoglycemia rates, weight impact, and cardiovascular outcomes. For instance, recent observational studies underscore that Lantus demonstrates a sustained safety profile, but differential hypoglycemia risk remains a clinical consideration [2].

• Fixed-Dose Combination Studies: Trials exploring insulin glargine combined with GLP-1 receptor agonists (e.g., lixisenatide) aim to optimize therapy, enhance adherence, and reduce injection burden. Notably, the SoliMix trial evaluated the efficacy and safety of insulin glargine combined with lixisenatide, approaching clinical practice application [3].

Regulatory Landscape and Market Approvals

Notably, in 2023, the FDA approved Lyumjev (insulin lispro-aabc), an ultra-rapid acting insulin, to complement basal insulin therapy. While this doesn't directly alter Lantus’s class, the regulatory environment indicates ongoing interest in refining insulin therapy strategies.

Innovations and Future Directions

Innovative research includes:

• Smart Insulin Delivery: Efforts to integrate Lantus into closed-loop insulin pump systems continue, aiming to optimize real-time glycemic control.

• Cell-based Therapies: Experimental trials are evaluating insulin-producing cell transplants as potential alternatives, which could challenge long-term insulin therapies like Lantus in the future.

---

Market Analysis

Historical Market Dynamics

Lantus dominated global insulin markets for over a decade, capturing a substantial portion of basal insulin sales. In 2015, it held approximately 45% of the basal insulin market, peaking due to its pharmacokinetic profile and favorable safety data [4].

Market Disruption by Biosimilars

Since 2018, biosimilar entries—such as Basaglar (Eli Lilly) and Semglee (Mylan/Biocon)—have eroded Lantus’s market share:

• Biosimilar adoption accelerated in Europe and parts of Asia, driven by pricing pressures and reimbursement policies.
• The U.S. Food and Drug Administration (FDA) approved the Semglee biosimilar in 2020, further intensifying competition.

By 2022, Lantus’s market share declined to below 30% in major markets, with biosimilars accounting for over 40%, and rapid market penetration expected to continue.

Market Size and Revenue

According to IQVIA data, the global insulin market was valued at approximately $24 billion in 2022, with basal insulins accounting for nearly half. Lantus’s global sales were approximately $4.2 billion in 2022, representing a decline from its peak, yet maintaining significant revenue owing to its brand perception and clinical legacy [5].

Emerging Opportunities

• Personalized Medicine: Increased demand for tailored insulin regimens supports the growth of slow/ultra-long acting insulins.
• Market Expansion in Emerging Economies: Rising diabetes prevalence and expanding healthcare infrastructure in Asia, Africa, and Latin America offer growth pathways.
• Combination Therapies: The increasing approval and adoption of fixed-dose combinations may stimulate demand for branded formulations aligned with Lantus.

Regulatory and Payer Dynamics

Pricing pressures from payers are intensifying, especially with biosimilars’ entries. Reimbursement policies increasingly favor cost-effective options, compelling Sanofi to innovate or differentiate Lantus through enhanced delivery systems or combination products.

---

Market Projection (2023–2030)

Forecast Overview

The insulin market is projected to grow at a compound annual growth rate (CAGR) of approximately 6–8% through 2030, driven by escalating diabetes prevalence and technological advancements [6].

Lantus’s Market Share Outlook

• Short-Term (2023–2025): Market share is expected to decline steadily due to biosimilar competition but remain significant due to brand loyalty and clinical familiarity.
• Mid to Long-Term (2025–2030): Growth prospects hinge on the product’s evolution—such as biosimilar differentiation, new delivery mechanisms, or label extensions.

Revenue Projections

• 2023–2025: Revenue declines are anticipated, possibly stabilizing around $2.5–3 billion annually.
• 2026–2030: Potential stabilization or modest growth could emerge from new formulations, combination products, or expanded indications.

Strategic Outlook

Sanofi’s focus on biosimilar pipeline expansion and innovation in insulin delivery suggests a strategic pivot toward maintaining market relevance. Investment in digital health integration and patient-centered delivery is critical to safeguard Lantus’s long-term positioning.

---

Key Takeaways

• Clinical Trial Developments: Ongoing studies continue to affirm Lantus’s long-term safety and efficacy, with emerging research on combinations and delivery innovations.
• Market Competition: Biosimilars have significantly eroded Lantus’s market share since 2018, driven by cost competition and regulatory approvals.
• Revenue Dynamics: While revenue is declining, Lantus remains a commercially valuable asset for Sanofi, especially in emerging markets.
• Future Growth Opportunities: Expansion into combination therapies, digital health integration, and personalized medicine are key to sustaining relevance.
• Investment Considerations: Stakeholders should monitor biosimilar and innovative developments, regulatory trends, and reimbursement policies affecting long-term profitability.

---

FAQs

1. How has the entry of biosimilars impacted Lantus’s market share?
Biosimilars like Basaglar and Semglee, approved in various markets since 2018, have captured a substantial portion of the basal insulin market, leading to Lantus’s market share decline from over 45% to below 30%, primarily due to competitive pricing and reimbursement strategies [4].

2. Are there any ongoing clinical trials that could enhance Lantus’s therapeutic profile?
Current trials focus on fixed-dose combinations with GLP-1 receptor agonists, aiming to improve glycemic control and reduce injection frequency, which could bolster Lantus’s clinical utility [3].

3. What are the key regulatory developments affecting Lantus?
Regulatory bodies continue to approve biosimilars to Lantus, with the FDA approving Semglee in 2020, promoting price competition and broader patient access. Additionally, research into delivery system innovations remains a regulatory focus.

4. What is the outlook for Lantus’s revenue over the next five years?
Revenue is projected to decline gradually due to biosimilar competition but may stabilize or slightly increase if new formulations or combination therapies are successfully commercialized.

5. How might digital health influence Lantus’s market prospects?
Integrating Lantus into closed-loop insulin pump systems and digital monitoring platforms can enhance therapeutic outcomes, improve adherence, and potentially revive market interest through personalized insulin management.

---

References

1. [1] European Medicines Agency. Biosimilar Insulins: Regulatory Pathways and Clinical Data. 2021.
2. [2] American Diabetes Association. Long-term Safety Profiles of Insulin Therapies. Diabetes Care. 2022.
3. [3] ClinicalTrials.gov. SoliMix: Evaluation of Insulin Glargine and Lixisenatide. NCT042***.
4. [4] IQVIA. Global Insulin Market Report. 2022.
5. [5] Sanofi Annual Report 2022.
6. [6] Grand View Research. Insulin Market Analysis and Forecast. 2023.