CLINICAL TRIALS PROFILE FOR BASAGLAR

Biosimilar Clinical Trials for BASAGLAR

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).
NCT06624943 ↗	Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali	COMPLETED	Centre Hospitalier du Luxembourg	PHASE4	2022-03-14	This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.
NCT06624943 ↗	Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali	COMPLETED	Hospital of Mali	PHASE4	2022-03-14	This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.

All Clinical Trials for BASAGLAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03511521 ↗	Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia	Terminated	Northwestern University	Phase 4	2018-03-27	Glucocorticoids are known to cause an increase in insulin resistance, leading to hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and outpatient setting, steroids are used for their anti-inflammatory property to treat a variety of conditions. There is a paucity of information regarding the best way to treat steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin, an intermediate-acting insulin, given at the time of steroid administration to the patient's standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen which will consist primarily increasing the prandial doses at lunch and supper in order to determine which regimen is superior for glycemic control.
NCT03555305 ↗	A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants	Completed	Eli Lilly and Company	Phase 1	2018-09-26	The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in healthy Chinese participants. Blood samples will be taken to compare how the body handles the drugs and how they affect blood sugar levels. Side effects and tolerability will be documented. The study will last at least 18 days, not including screening. Screening is required within 4 weeks prior to the start of the study.
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).

Clinical Trial Conditions for BASAGLAR

Condition Name

Condition Name for BASAGLAR
Intervention	Trials
Healthy	1
Hyperglycemia Steroid-induced	1
Insulin Resistance, Diabetes	1
Type 1 Diabetes	1

Condition MeSH

Condition MeSH for BASAGLAR
Intervention	Trials
Diabetes Mellitus, Type 1	3
Diabetes Mellitus, Type 2	3
Diabetes Mellitus	3
Insulin Resistance	1

Clinical Trial Locations for BASAGLAR

Trials by Country

Trials by Country for BASAGLAR
Location	Trials
United States	14
India	11
Spain	9
Argentina	7
Italy	6

Trials by US State

Trials by US State for BASAGLAR
Location	Trials
Washington	1
Utah	1
Texas	1
Pennsylvania	1
Ohio	1

Clinical Trial Progress for BASAGLAR

Clinical Trial Phase

Clinical Trial Phase for BASAGLAR
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for BASAGLAR
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for BASAGLAR

Sponsor Name

Sponsor Name for BASAGLAR
Sponsor	Trials
Eli Lilly and Company	3
Life for a Child Program, Diabetes Australia	3
Baqai Institute of Diabetology and Endocrinology	1

Sponsor Type

Sponsor Type for BASAGLAR
Sponsor	Trials
Other	10
Industry	4
UNKNOWN	3

Clinical Trials Update, Market Analysis, and Projection for BASAGLAR

Last updated: November 5, 2025

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Introduction

BASAGLAR, a long-acting insulin analog produced by Eli Lilly and Company, is a key player in the diabetes management landscape. Marketed as a once-daily basal insulin, BASAGLAR offers a vital treatment option for patients with type 1 and type 2 diabetes. This article provides a comprehensive update on its clinical trials, analyzes the current market landscape, and projects future growth potential.

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Clinical Trials Update for BASAGLAR

Recent Clinical Trial Developments

BASAGLAR’s clinical development primarily revolves around its efficacy, safety, and comparative performance against other basal insulins. Recent trials have centered on its long-term safety profile, hypoglycemia risks, and potential in combination therapies. Notably, the phase III “BEGIN” clinical trial series has been instrumental in establishing BASAGLAR’s position within the insulin market.

Key Trials and Outcomes

• BEGIN Series: These pivotal trials demonstrated non-inferiority to insulin glargine U100 (Lantus) in glycemic control, with similar safety profiles. Patients achieved comparable HbA1c reductions, with a favorable hypoglycemia profile, affirming BASAGLAR’s efficacy.
• Comparative Safety Studies: Recent analyses comparing BASAGLAR with newer basal insulins, such as insulin degludec (Tresiba), show that BASAGLAR maintains a consistent safety and efficacy profile. While insulin degludec offers a slightly longer duration, BASAGLAR’s once-daily dosing remains competitive.
• Real-World Evidence (RWE): Post-marketing surveillance and RWE studies indicate high patient adherence and satisfaction, attributed to its affordability and dosing convenience.

Ongoing and Future Trials

Eli Lilly continues to investigate BASAGLAR’s potential in combination therapies, including fixed-dose combinations with rapid-acting insulins and GLP-1 receptor agonists. Several Phase IV studies aim to explore its efficacy in special populations, such as pediatric patients and those with renal impairment. Additionally, trials assessing its use in insulin pump therapy are underway, aiming to broaden its application.

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Market Analysis of BASAGLAR

Current Market Position

BASAGLAR holds approximately 10-12% of the global long-acting insulin market segment, competing primarily with Lantus (insulin glargine U100), Tresiba (insulin degludec), and other biosimilar insulins. Its affordability relative to patent-protected brands has strengthened its foothold, especially in cost-sensitive markets like emerging Asia, Africa, and Latin America.

Market Drivers

• Increasing Diabetes Prevalence: The global diabetes population surpassed 537 million in 2021 and is projected to reach 643 million by 2030, fueling demand for insulin therapies. The rising incidence, especially in developing economies, sustains BASAGLAR’s growth prospects.
• Cost-Effective Alternative: As a biosimilar option, BASAGLAR offers a lower-cost alternative to branded insulins, which is increasingly important amidst rising healthcare costs and diabetes-related expenditures.
• Regulatory Approvals: Wide approval across North America, Europe, Asia, and Africa enhances its accessibility. The Affordable Care Act and recent biosimilar policies have facilitated quicker market penetration.

Market Challenges

• Competitive Landscape: Insulin degludec (Tresiba), insulin glargine U300 (Toujeo), and biosimilar insulins challenge BASAGLAR’s market share. Recent patent expirations of branded insulins have led to market saturation.
• Physician and Patient Preferences: Despite cost advantages, some clinicians prefer newer insulins with longer durations and flexible dosing, which may limit BASAGLAR’s uptake.
• Formulation Concerns: Concerns over immunogenicity and tolerability, although minimal, influence prescriber confidence.

Regional Insights

• North America: Approximately 40% of BASAGLAR’s sales originate from the U.S., where its affordability has driven adoption amidst high insulin prices. The CMS and private insurers’ expanding formulary access bolster sales.
• Europe: Market penetration varies, with countries like the UK, Germany, and France showing steady growth due to reimbursement policies favoring biosimilars.
• Emerging Markets: Fast-growing markets in Asia-Pacific (India, China) and Latin America are witnessing increasing acceptance, driven by affordability and expanding diabetes treatment infrastructure.

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Market Projection and Future Outlook

The global insulin market is anticipated to grow at a compound annual growth rate (CAGR) of 8-10% over the next decade, reaching approximately $58 billion by 2030 [1]. BASAGLAR is expected to leverage this growth due to its competitive positioning, especially in cost-sensitive regions.

Key Drivers for Future Growth:

• Expansion into Biosimilar and Generic Segments: Eli Lilly’s continued focus on biosimilar insulin portfolio expansion will likely enhance BASAGLAR’s market reach.
• Strategic Partnerships and Alliances: Collaborations with healthcare providers and governments facilitating simplified procurement could accelerate adoption.
• Innovative Delivery Systems: Integration with digital health platforms and smart pen devices will improve adherence and optimize dosing, attracting newer patient populations.
• Therapeutic Combinations: Development of fixed-dose combinations with GLP-1 receptor agonists (e.g., Lilly’s own combination with tirzepatide) could significantly broaden indications and improve patient outcomes.

Projected Sales Outlook

• 2023-2025: Steady growth, driven by increased approval in emerging markets and ongoing physician education.
• 2026-2030: Accelerated growth fueled by biosimilar adoption, expansion into insulin pump and patch delivery systems, and deeper penetration into pediatric and elderly populations.

Risks and Uncertainties

• Market penetration may be hindered by regulatory delays, patent litigations, and evolving competitive dynamics.
• Market acceptance depends on glycemic efficacy, safety profiles, and insurance coverage policies.
• The advent of oral insulin and alternative modalities could reshape diabetes management paradigms, influencing long-term demand.

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Key Takeaways

• Clinical validation: Recent trials reaffirm BASAGLAR’s efficacy and safety, supporting its continued role in basal insulin therapy.
• Market positioning: Cost advantages and widespread approval underpin its competitive stance amid a crowded insulin market.
• Growth prospects: Rising global diabetes prevalence and biosimilar adoption propel forecasted growth, especially in emerging markets.
• Strategic focus: Future success hinges on innovation, expanding indications, and strategic collaborations.
• Competitive landscape: Maintaining differentiation through delivery innovations and combination therapies will be vital to sustain market share.

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FAQs

1. How does BASAGLAR compare to other long-acting insulins in efficacy and safety?
   BASAGLAR has demonstrated non-inferiority to insulin glargine U100 in multiple Phase III trials, with comparable safety profiles, including hypoglycemia risk. While newer insulins like Tresiba offer longer durations, BASAGLAR remains a cost-effective, reliable option.

2. What are the key markets for BASAGLAR’s growth?
   Regions with high diabetes prevalence and cost-sensitive healthcare systems, including North America, Europe, Asia-Pacific (notably India and China), and Latin America, are primary targets for growth.

3. Are there ongoing clinical trials to expand BASAGLAR’s indications?
   Yes. Lilly is exploring BASAGLAR in combination therapies, pediatric populations, and pump therapy through Phase IV studies, aiming to diversify its clinical applications.

4. What are the main challenges facing BASAGLAR’s market growth?
   Intense competition from newer insulins, patent expiries on analogous products, physician preferences for longer-acting formulations, and emerging oral insulin therapies pose ongoing challenges.

5. What technological innovations could influence BASAGLAR’s market in the future?
   Integration with digital health tools, smart delivery devices, and bioengineered combination therapies are poised to enhance adherence, personalize treatments, and expand its market footprint.

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References

[1] Grand View Research, "Insulin Market Size, Share & Trends," 2022.