CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE

505(b)(2) Clinical Trials for Insulin Glargine

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 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
New Formulation	NCT01658579 ↗	Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin	Completed	Sanofi	Phase 2	2012-08-01	Primary Objective: - To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: - To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening - To compare the incidence and frequency of hypoglycemic episodes - To assess the safety and tolerability of the new formulation of insulin glargine
New Formulation	NCT01676220 ↗	Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy	Completed	Sanofi	Phase 3	2012-08-01	Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: - occurrence of nocturnal hypoglycemia

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.
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 Insulin Glargine

Condition Name

Condition Name for Insulin Glargine
Intervention	Trials
Diabetes Mellitus, Type 2	161
Type 2 Diabetes Mellitus	93
Diabetes	89
Type 2 Diabetes	73

Condition MeSH

Condition MeSH for Insulin Glargine
Intervention	Trials
Diabetes Mellitus	460
Diabetes Mellitus, Type 2	338
Diabetes Mellitus, Type 1	125
Hyperglycemia	29

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	12
PHASE3	9
PHASE2	2

Clinical Trial Status

Clinical Trial Status for Insulin Glargine
Clinical Trial Phase	Trials
Completed	433
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	479
Other	305
NIH	10

Insulin Glargine: Clinical Trials Update, Market Analysis and Projection

Last updated: April 28, 2026

What is insulin glargine and why does it matter for late-stage pipelines?

Insulin glargine is a long-acting basal insulin used to manage diabetes mellitus. It is a platform drug class member with multiple marketed “generations” and biosimilar competition, shaping both clinical development strategies and commercial pricing dynamics.

From a patent-analytics perspective, the market is dominated by:

• Original glargine (commonly associated with Lantus)
• Reformulations and next-generation long-acting analogs (e.g., glargine derivatives) that compete for the basal insulin category
• Biosimilar glargine products that compress spend and increase payer leverage

Which clinical trials are currently relevant and where do they concentrate?

A complete “clinical trials update” for insulin glargine requires pulling current trial statuses and enrollment for each registered study (ClinicalTrials.gov and major regional registries). The prompt does not include trial identifiers, geography scope, or a cut date. Without those inputs, a complete and accurate, source-cited trial status roll-up cannot be produced.

No further clinical trial enumeration is provided.

How does insulin glargine fit into the basal insulin market structure?

Basal insulin use is driven by:

• Chronic dosing adherence and hypoglycemia risk management
• Payer coverage rules (formulary position and step edits)
• Switching dynamics to long-acting analogs, including biosimilar entry and next-generation products

Commercial positioning is typically organized into:

• Value-tier generics/biosimilars (price competition)
• Preferred formulary products (contracting and rebate frameworks)
• Next-generation basal analogs (clinical differentiators used to support formulary preference and economics)

What does the market analysis say about insulin glargine growth, pricing, and volume?

A defensible market projection for insulin glargine depends on:

• Global and regional market sizing definitions (basal insulin only vs total insulin spend)
• Whether glargine includes only the “glargine” molecule and brand/biosimilar set, or includes glargine derivatives under a broader category
• Inclusion or exclusion of adjacent basal products (detemir, degludec, and others)

The prompt provides no market sizing source, geography, or definitional boundaries. Without that, a complete, accurate projection cannot be produced.

No market sizing figures or numeric forecast series are provided.

What are the main drivers and constraints for insulin glargine commercialization?

Market behavior for insulin glargine is dominated by the following real-world levers:

Biosimilar penetration and payer contracting

• Increased competitive SKUs reduce average selling prices via tendering and rebate compression.
• Formulary decisions can shift demand quickly if a biosimilar is placed as “preferred” with equivalent clinical labeling.

Switching economics and channel strategy

• Pharmacy benefit managers and national healthcare systems often incentivize switching.
• Manufacturer contracting can anchor share to specific payers and health systems.

Category substitution risk from newer basal analogs

• Other long-acting insulins with favorable dosing convenience, glycemic outcomes, and safety profiles can displace some glargine volume at the margin.
• Differentiation may be used in negotiations to retain or grow share in preferred tiers.

How should investors and R&D teams think about insulin glargine pipeline risk?

Key risk categories in an insulin biosimilar and basal analog landscape:

• Regulatory path constraints (comparability, immunogenicity data packages, manufacturing changes)
• Commercial risk (formulary exclusion, tender cycles, price compression)
• Patent and exclusivity risk (beyond the molecule, including device, formulation, and method-of-use where applicable)

A complete patent-driven risk map is not possible without the patent family set, jurisdictions, and listed exclusivities for each product and country.

What is the projected outlook for insulin glargine through the next cycle?

A forward-looking outlook with numbers (2026-2035 revenue, CAGR, share, or unit forecasts) requires a defined dataset and cited market-source model. The prompt does not provide any baseline market estimate source, unit assumptions, or projection method; producing figures without those would be non-actionable and not auditable.

No numeric projection is provided.

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Key Takeaways

• Insulin glargine is a basal insulin category anchor, but its economics are heavily shaped by biosimilar penetration and payer contracting.
• A complete “clinical trials update” requires trial-level extraction and a defined cut date and geography; none is provided.
• A credible “market analysis and projection” requires a defined market scope and cited sizing source; none is provided.

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FAQs

1. Is insulin glargine still growing in the basal insulin category?
   Growth dynamics depend on biosimilar penetration, pricing, and formulary preferences by region and payer; no sourced trend series is provided here.

2. What determines payer preference between glargine and other basal insulins?
   Contracted net price, formulary placement, step therapy, and perceived clinical outcomes.

3. How do biosimilars affect insulin glargine pricing?
   They typically compress average selling prices and increase demand elasticity through tendering and preferred-tier placement.

4. What types of trials matter most for insulin glargine updates?
   Trials focused on comparative glycemic control, hypoglycemia rates, immunogenicity, and real-world switching outcomes.

5. What is the largest investment risk in the glargine space?
   Commercial risk from price compression and formulary exclusion combined with regulatory and manufacturing execution risk.

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References

[1] ClinicalTrials.gov. (n.d.). Insulin glargine search results. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Insulin products: approvals and labeling information. https://www.fda.gov/Drugs/DrugApprovalsandDatabases/ucm080167.htm
[3] International Diabetes Federation. (n.d.). Diabetes statistics and reports. https://www.diabetesatlas.org/