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
New Formulation	NCT01499095 ↗	Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy	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 Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: - 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.
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.

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
Phase 4	105
Phase 3	69
Phase 2	12

Clinical Trial Status

Clinical Trial Status for Lantus
Clinical Trial Phase	Trials
Completed	199
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	205
Other	146
NIH	9

LANTUS (Insulin Glargine): Clinical Trials, Market Analysis, and Projections

Introduction to LANTUS

LANTUS, developed by Sanofi, is a long-acting human insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged two years and above. It is administered once daily and has been a cornerstone in diabetes management for many years.

Clinical Trials Update

Lannett's Biosimilar Insulin Glargine

Lannett Company, Inc. has made significant progress in the development of a biosimilar to LANTUS. In March 2022, Lannett initiated a pivotal clinical trial for its biosimilar insulin glargine, which is being co-developed with the HEC Group of companies. The first patient was dosed, and top-line study results are expected by the end of 2022. If successful, Lannett anticipates filing the Biologics License Application (BLA) in early 2023 and potentially launching the product in the first half of 2024[1][4].

Previous Studies and FDA Approval

The pivotal trial follows a previously completed first human volunteer pilot study, which suggested that Lannett's insulin glargine product would be biosimilar to US-approved LANTUS in terms of pharmacokinetics (PK) and pharmacodynamics (PD) endpoints. The FDA's acceptance of the Investigational New Drug (IND) application with no comments further supports the optimism for a successful outcome[1].

Market Analysis

Current Market Dominance of LANTUS

Despite the emergence of biosimilars, LANTUS still maintains a significant market share. As of 2023, LANTUS holds 78% of the total market volume and 54% of new drug starts, even with competition from biosimilars like Semglee[2].

Competition from Biosimilars

Semglee, an interchangeable biosimilar to LANTUS, has seen modest uptake since its launch in 2021. While it has gained some market share, particularly in the commercial space with 24% of new-to-brand starts, its overall impact on LANTUS's market dominance has been limited. The wholesale acquisition cost (WAC) of Semglee is not significantly lower than LANTUS, which may contribute to its slower adoption[2].

Pricing Strategies

Sanofi has announced a significant price reduction for LANTUS, starting January 2024, with a 78% cut in the list price and a $35 cap on out-of-pocket costs for patients with commercial insurance. This move is expected to further influence the market dynamics and potentially impact the adoption of biosimilars[2].

Market Projections

Global Insulin Glargine Market

The global insulin glargine market was valued at USD 1290 million in 2022 and is projected to reach USD 2200 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.11% during the forecast period (2023-2031). This growth is driven by the increasing prevalence of diabetes globally, largely due to sedentary lifestyles[3].

Sales Trends for LANTUS

In the first quarter of 2024, LANTUS sales experienced a decline of 15.4% to €360 million, with a significant drop in the US and China. However, this decline is partly offset by shifts in market dynamics, such as competitor medicines withdrawing from the market and changes in sales channel mix[5].

Impact of Biosimilars on LANTUS Sales

Market Share and Uptake

Despite the launch of biosimilars like Rezvoglar by Eli Lilly and Semglee, LANTUS continues to dominate the market. However, the slow but consistent uptake of unbranded biosimilar insulin glargine, particularly in managed Medicaid, indicates a gradual shift towards more affordable alternatives[2].

Pricing and Accessibility

The pricing strategies of both the original product and its biosimilars play a crucial role in market dynamics. Sanofi's decision to reduce the price of LANTUS significantly could impact the adoption rates of biosimilars, making LANTUS more competitive in the market[2].

Regulatory Environment

FDA Approvals and IND Applications

The FDA has approved several biosimilars to LANTUS, including Rezvoglar by Eli Lilly and Semglee. Lannett's submission of an IND application for its biosimilar insulin glargine and the FDA's acceptance without comments highlight the regulatory environment's support for biosimilar development[1][4].

Patient Impact

Cost and Accessibility

The introduction of biosimilars and the subsequent price reductions by original manufacturers like Sanofi are expected to make insulin glargine more accessible to patients. The $35 cap on out-of-pocket costs for patients with commercial insurance is a significant step towards reducing the financial burden on diabetes patients[2].

Clinical Outcomes

Biosimilars, such as those developed by Lannett and Eli Lilly, have shown comparable pharmacokinetics and pharmacodynamics to LANTUS, ensuring that patients receive high-quality, effective treatment options at a lower cost[1][4].

Key Takeaways

• Lannett's biosimilar insulin glargine is in pivotal clinical trials, with expected top-line results by the end of 2022 and potential launch in early 2024.
• LANTUS maintains a significant market share despite competition from biosimilars.
• Sanofi's price reduction for LANTUS in 2024 is expected to impact market dynamics.
• The global insulin glargine market is projected to grow at a CAGR of 6.11% from 2023 to 2031.
• Biosimilars are gradually gaining market share, particularly in managed Medicaid and commercial spaces.

FAQs

What is the current status of Lannett's biosimilar insulin glargine clinical trial?

Lannett has initiated the pivotal clinical trial for its biosimilar insulin glargine, with the first patient dosed in March 2022. Top-line study results are expected by the end of 2022, and a potential launch is anticipated in the first half of 2024[1].

How has the market share of LANTUS been affected by biosimilars?

Despite the launch of biosimilars like Semglee, LANTUS still holds 78% of the total market volume and 54% of new drug starts. However, biosimilars have seen modest uptake, particularly in the commercial space[2].

What pricing strategies have been announced by Sanofi for LANTUS?

Sanofi has announced a 78% reduction in the list price of LANTUS starting January 2024 and will establish a $35 cap on out-of-pocket costs for patients with commercial insurance[2].

What is the projected growth of the global insulin glargine market?

The global insulin glargine market is projected to grow from USD 1290 million in 2022 to USD 2200 million by 2031, at a CAGR of 6.11% during the forecast period[3].

How do biosimilars compare to LANTUS in terms of clinical outcomes?

Biosimilars, such as those developed by Lannett and Eli Lilly, have shown comparable pharmacokinetics and pharmacodynamics to LANTUS, ensuring that patients receive high-quality, effective treatment options[1][4].

What regulatory approvals have been received by biosimilars to LANTUS?

The FDA has approved several biosimilars to LANTUS, including Rezvoglar by Eli Lilly and Semglee. Lannett's IND application for its biosimilar insulin glargine has been accepted by the FDA without comments[1][4].

Sources

1. Lannett Initiates Pivotal Clinical Trial For Biosimilar Insulin Glargine. Biospace.
2. Payer Controls Limiting Semglee Uptake Despite Patient Demand. AJMC.
3. Insulin Glargine Market Size to Reach 2200 Million by 2031. Straits Research.
4. Recent Insulin Glargine Biosimilar Developments. Goodwin Law.
5. Sanofi Q1: robust 7% sales growth driven by .... Sanofi Press Release.