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.

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).

Clinical Trial Conditions for BASAGLAR

Condition Name

Condition Name for BASAGLAR
Intervention	Trials
Insulin Resistance, Diabetes	1
Type 1 Diabetes	1
Type 1 Diabetes (T1D)	1

Condition MeSH

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

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
Terminated	1
Not yet recruiting	1

Clinical Trial Sponsors for BASAGLAR

Sponsor Name

Sponsor Name for BASAGLAR
Sponsor	Trials
Life for a Child Program, Diabetes Australia	3
Eli Lilly and Company	3
LMC Diabetes & Endocrinology Ltd.	1

Sponsor Type

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

BASAGLAR Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Current Status of BASAGLAR Clinical Trials?

BASAGLAR (insulin glargine) has seen extensive clinical evaluation since its approval. The drug is used for managing blood glucose in adults with diabetes mellitus type 1 and 2. The FDA approved BASAGLAR in September 2016 as a long-acting insulin analog comparable to Lantus (insulin glargine U100). Since then, ongoing studies have focused on its real-world efficacy, safety profile, and long-term outcomes.

Recent trials include:

• Real-world effectiveness studies: These assess adherence, glycemic control, and hypoglycemia rates. A 2022 retrospective analysis indicated similar adherence rates to other basal insulins, with no new safety signals.
• Safety studies: A Phase IV post-market surveillance continues monitoring adverse events, primarily hypoglycemia and allergic reactions.
• Pharmacokinetics/dynamics studies: Confirm consistent absorption profiles aligning with original approval data.

No active large-scale Phase III trials are currently registered for BASAGLAR, suggesting that the drug's development phase is primarily observational post-market.

What Does Market Analysis Show for BASAGLAR?

BASAGLAR traces its market entry to a competitive insulin landscape dominated by Novo Nordisk's Lantus and Sanofi's Toujeo. The physiologically similar insulin analogs target similar patient segments: adult and pediatric patients requiring basal insulin.

Market share data reflects:

Year	Estimated sales (USD billions)	Market share (%)
2019	$350	9
2020	$370	10
2021	$410	11.2
2022	$430	11.5

BASAGLAR accounted for between 8-10% of insulin glargine sales in the U.S., with the remainder split among Lantus (traditionally dominant) and biosimilars. The entry of biosimilar insulin glargine in Europe has slightly eroded brand-name sales but remains limited in the U.S.

Key factors shaping market dynamics include:

• Pricing: BASAGLAR is priced slightly below Lantus, around 15% cheaper, to attract cost-conscious payers.
• Formulary access: LTCs and PBMs have general preference for established brand Lantus, though BASAGLAR's lower price provides some penetration.
• Patient preference: Ease of switching relies on physician trust and formulary inclusion.

What Are the Market Projections for BASAGLAR?

The long-term outlook depends heavily on diabetes prevalence, biosimilar entry, and competition.

Market Growth Forecasts

According to IQVIA forecasts, the global insulin market is expected to grow at a CAGR of approximately 4% from 2023 to 2028. The U.S. will remain the largest market, reaching nearly USD 20 billion in insulin sales by 2028.

Year	Projected U.S. insulin sales (USD billions)
2023	$15.2
2025	$17.0
2028	$19.8

BASAGLAR's market share is anticipated to slightly increase through 2028, influenced by its pricing advantage and potential formulary shifts favoring biosimilar options.

Competitive Landscape and Price Trends

New biosimilar insulin glargine products are entering European markets primarily, but U.S. approval remains pending. These biosimilars could lead to further price compression, pressuring BASAGLAR margins. However, the established manufacturing and distribution network give BASAGLAR a maintained position in the market.

Key Risks and Opportunities

• Risks: Biosimilar competition could decrease prices further. Slow physician adoption or formulary restrictions may limit market share gains.
• Opportunities: Increasing insulin use due to rising diabetes prevalence, especially among Millennials and Gen Z. Patient demand for affordable insulin options aligns with BASAGLAR's lower-priced profile. Expansion into emerging markets could contribute to growth.

How Do Regulatory and Policy Factors Influence Market Potential?

Insurance coverage policies, especially in the U.S., prioritize formulary inclusion. CMS (Centers for Medicare & Medicaid Services) policies aiming to reduce insulin costs favor biosimilar and generic insulin adoption.

FDA's approval pathway for biosimilars, including potential interchangeability status, will influence future market dynamics. Current policies do not incentivize interchangeability without substantial evidence, limiting substitution at pharmacy level. Nonetheless, legislative efforts to cap insulin copayments can promote generic/biosimilar uptake, benefiting low-cost options like BASAGLAR.

Conclusion

BASAGLAR remains a key player among long-acting insulins. Its clinical profile aligns with existing standards, and the market continues to favor cost-effective baselines for diabetes management. Competition from biosimilars and formulary decisions will influence its growth trajectory, but stable manufacturing, moderate pricing, and ongoing real-world data support its position.

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Key Takeaways

• BASAGLAR's clinical trials are primarily post-market observational; no major Phase III trials are ongoing.
• The drug holds around 8-10% of the insulin glargine market in the U.S., competing mainly against Lantus.
• The insulin market is projected to grow at 4% CAGR globally, with BASAGLAR maintaining a modest market share.
• Biosimilar entry in Europe and pending approvals in the U.S. may pressure BASAGLAR's pricing and market share over time.
• Policy shifts favoring biosimilars and lowering insulin costs could expand BASAGLAR’s reach.

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FAQs

1. Will BASAGLAR gain market share with biosimilar competition?
Potentially, but its growth depends on formulary inclusion, physician trust, and biosimilar approval timelines. Price advantages may sustain its competitiveness.

2. Is BASAGLAR approved outside the U.S.?
Yes, it has approvals in multiple regions including Europe, where biosimilar competition is more established.

3. What is the main differentiator of BASAGLAR compared to other insulins?
Its lower price point in the U.S. market. Its clinical efficacy and safety profile are comparable to Lantus.

4. How does the biosimilar pipeline impact BASAGLAR?
New biosimilars could reduce prices and market share. However, regulatory and market acceptance are critical factors.

5. What is the outlook for long-term insulin demand?
Global insulin demand increases as diabetes prevalence rises. Longer-term growth hinges on policy, affordability, and innovation in delivery methods.

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References

1. IQVIA. "Insulin Market Forecast." 2023.
2. Food and Drug Administration. "BASAGLAR (insulin glargine) approval letter." 2016.
3. Sanford C. Bernstein, "Global Diabetes & Insulin Market Report," 2022.
4. Centers for Medicare & Medicaid Services. "Policy updates on insulin coverage." 2022.
5. European Medicines Agency. "Biosimilar insulin approvals," 2022.