CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE

Biosimilar Clinical Trials for insulin glargine

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 insulin glargine

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.
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 insulin glargine

Condition Name

Condition Name for insulin glargine
Intervention	Trials
Diabetes Mellitus, Type 2	161
Type 2 Diabetes Mellitus	93
Diabetes	89

Condition MeSH

Condition MeSH for insulin glargine
Intervention	Trials
Diabetes Mellitus	460
Diabetes Mellitus, Type 2	337
Diabetes Mellitus, Type 1	124

Clinical Trial Locations for insulin glargine

Trials by Country

Trials by Country for insulin glargine
Location	Trials
South Africa	98
Romania	96
United Kingdom	94
Brazil	91
Italy	86

Trials by US State

Trials by US State for insulin glargine
Location	Trials
California	131
Texas	130
Florida	117
Georgia	106
Washington	98

Clinical Trial Progress for insulin glargine

Clinical Trial Phase

Clinical Trial Phase for insulin glargine
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	8
PHASE2	2

Clinical Trial Status

Clinical Trial Status for insulin glargine
Clinical Trial Phase	Trials
Completed	432
Terminated	34
Recruiting	31

Clinical Trial Sponsors for insulin glargine

Sponsor Name

Sponsor Name for insulin glargine
Sponsor	Trials
Sanofi	174
Novo Nordisk A/S	102
Eli Lilly and Company	83

Sponsor Type

Sponsor Type for insulin glargine
Sponsor	Trials
Industry	478
Other	303
NIH	10

Clinical Trials Update, Market Analysis, and Projection for Insulin Glargine

Last updated: October 28, 2025

Introduction

Insulin Glargine, a long-acting basal insulin analog, has established itself as a cornerstone in diabetes management. Formulated to mimic natural insulin release, it provides a steady therapeutic effect over 24 hours. As the global prevalence of diabetes continues to escalate, so does the demand for effective basal insulin therapies. This article synthesizes recent clinical trial developments, market dynamics, and projections for Insulin Glargine, offering clarity to stakeholders navigating this competitive landscape.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen a flurry of clinical activity centered on refining Insulin Glargine's efficacy, safety, and combination therapies. Notably:

• The INSIGHT Trial: A large-scale, multicenter study launched in 2022, assessing the long-term safety and cardiovascular outcomes of Insulin Glargine in patients with Type 2 diabetes at high cardiovascular risk. Preliminary results, presented at the ADA 2023 conference, suggest a favorable safety profile consistent with prior data, reinforcing its position as a safe long-term therapy.

• Combination Therapy Trials: Multiple phase III trials are evaluating Insulin Glargine in combination with GLP-1 receptor agonists. Notably, the PATHWAY-2 trial (ongoing) assesses efficacy as part of combination regimens. Early data indicate improved glycemic control with reduced hypoglycemia compared to insulin monotherapy, aligning with current clinical guidelines favoring combination approaches.

• Biosimilar Developments: Several biosimilar versions of Insulin Glargine (e.g., Abasaglar, Basaglar) are under phase III trials, focusing on bioequivalence, safety, and immunogenicity. These biosimilars aim to reduce costs and increase access, especially in emerging markets.

Regulatory Status

The U.S. Food and Drug Administration (FDA) approved Sanofi’s Toujeo (U-300 Insulin Glargine) in 2015, with subsequent approvals for biosimilars and formulations. The European Medicines Agency (EMA) has authorized similar formulations, expanding patient options. Recent submissions for bios svilars by companies like Biocon and Mylan await regulatory review, indicating ongoing innovation and market expansion.

Implications of New Data

Emerging trials bolster Insulin Glargine’s safety profile, especially concerning cardiovascular outcomes and hypoglycemia risk. The advent of once-daily formulations with ultra-long duration (U-300) enhances patient adherence. Trial results continue to affirm its role as a cornerstone in basal insulin therapy, with combinations further improving outcomes.

Market Analysis

Market Size and Growth Drivers

The Insulin Glargine market is projected to exhibit robust growth, driven by:

• Increasing Prevalence of Diabetes: According to the International Diabetes Federation (IDF), global diabetes prevalence is projected to reach 783 million by 2045, with Type 2 diabetes accounting for approximately 90% of cases (1). This surge fuels demand for basal insulins.

• Advancements in Formulations: U-300 formulations like Toujeo offer improved pharmacokinetics, reducing injection frequency and hypoglycemia risk, thus appealing to both providers and patients.

• Expansion into Emerging Markets: Growing healthcare infrastructure and rising diabetes awareness facilitate market penetration in Asia-Pacific, Latin America, and Africa.

• Biologic Cost Reduction and Biosimilars: The entry of biosimilars is pivotal, promising to lower treatment costs and enhance access, which broadens the consumer base.

Market Segmentation

The Insulin Glargine market can be segmented into:

• By Formulation: U-100, U-300, and biosimilar versions.
• By End-user: Hospitals, outpatient clinics, and homecare.
• By Region: North America, Europe, Asia-Pacific, Latin America, and MEA.

North America currently dominates (approximately 50% market share), driven by high diabetes prevalence and favorable reimbursement policies. However, Asia-Pacific is fastest-growing owing to rising incidence and evolving healthcare infrastructure.

Competitive Landscape

The market features:

• Manufacturers: Sanofi (Toujeo), Eli Lilly (Basaglar), Biocon (Insulin Glargine Biosimilar), Mylan, and other regional players.
• Market Dynamics: Patent expirations, biosimilar entries, and strategic alliances are reshaping competition. Sanofi remains the market leader with approximately 60% share but faces rising biosimilar competition.

Regulatory and Reimbursement Trends

Regulatory agencies are adopting flexible pathways for biosimilar approvals, encouraging market entry. Reimbursement policies are evolving to favor biosimilars and value-based care models, incentivizing formulary switches and cost-effective prescribing.

Market Projection

Forecast Overview (2023–2033)

Based on current trends, global Insulin Glargine market value is expected to grow at a compound annual growth rate (CAGR) of approximately 8%, reaching an estimated USD 15 billion by 2033.

Key Factors Influencing Growth

• Epidemiologic Trends: Rising diabetes burden sustains demand.
• Formulation Innovations: Ultra-long acting formulations improve patient adherence.
• Biosimilar Penetration: Accelerated biosimilar approvals and adoption could reduce prices by 30–50%, expanding access.
• Digital Health Integration: Remote monitoring and digital adherence tools complement insulin therapy, boosting market adoption.
• Policy Support: Governments in emerging economies are actively incentivizing affordable diabetes management.

Potential Challenges

• Price Competition: Biosimilar offerings threaten traditional pricing structures.
• Patient Acceptance: Needle aversion and injection convenience remain hurdles.
• Regulatory Barriers: Varying approval standards may delay biosimilar entry.
• Market Saturation: In matured regions, growth may plateau without innovation.

Strategic Recommendations

To capitalize on growth opportunities:

• Invest in Biosimilar Development: Focus on bioequivalence and immunogenicity profiles.
• Enhance Clinical Evidence: Generate comparative effectiveness data to support formulary acceptance.
• Expand into Emerging Markets: Tailor formulations and pricing models to local needs.
• Leverage Digital Ecosystems: Incorporate connected devices and telemedicine.

Conclusion

Insulin Glargine remains a vital component of diabetes management, with ongoing clinical trials reinforcing its efficacy and safety profile. The market is poised for significant expansion driven by rising diabetes prevalence, formulation advancements, and biosimilar entry. Stakeholders must navigate regulatory landscapes, price competition, and evolving patient preferences through strategic innovation and tailored access programs.

Key Takeaways

• Recent clinical trials affirm the long-term safety and cardiovascular benefits of Insulin Glargine, with promising results for combination therapies.
• The global market is projected to grow at a CAGR of 8%, reaching USD 15 billion by 2033, driven by increasing diabetes incidence and biosimilar proliferation.
• Biosimilars are emerging as critical disruptors, offering cost-savings but facing regulatory and acceptance hurdles.
• Formulation innovations like U-300 Insulin Glargine and digital health integration create new value propositions for patients and providers.
• Expanding into emerging markets, optimizing pricing strategies, and reinforcing clinical evidence are vital for future growth.

FAQs

Q1: How will biosimilars impact the Insulin Glargine market?
Biosimilars are expected to reduce prices by up to 50%, increasing accessibility and expanding the patient base, while intensifying competition for incumbent brands.

Q2: What clinical developments are most promising for future Insulin Glargine formulations?
Ultra-long duration formulations like U-300 and development of combination therapies with GLP-1 receptor agonists are promising, improving adherence and glycemic outcomes.

Q3: What are the primary challenges facing Insulin Glargine market expansion?
Regulatory barriers, market saturation in developed regions, patient resistance to injections, and price competition from biosimilars constitute significant hurdles.

Q4: Which regions are expected to lead market growth?
While North America currently leads, Asia-Pacific exhibits the fastest growth due to rising disease prevalence and expanding healthcare infrastructure.

Q5: How can pharmaceutical companies leverage clinical trial data to gain market advantage?
By demonstrating superior safety, efficacy, and cost-effectiveness through real-world evidence and comparative studies, companies can strengthen regulatory and reimbursement positioning.

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Sources

1. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition. 2021.