CLINICAL TRIALS PROFILE FOR HUMULIN L

All Clinical Trials for Humulin L

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00522210 ↗	Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes	Completed	University of Calgary	N/A	2008-03-01	The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).
NCT00532766 ↗	Evaluating Pharmacokinetics and Pharmacodynamics of Jusline	Completed	King Saud University	N/A	2006-11-01	To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.
NCT00646581 ↗	Effect of Single Dose Intranasal Insulin On Cognitive Function	Completed	University of Massachusetts, Worcester	Phase 4	2006-10-01	The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include: 1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory. 2. Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.
NCT00657930 ↗	Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)	Completed	Novo Nordisk A/S		2008-03-01	This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.
NCT00705536 ↗	Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20	Completed	Halozyme Therapeutics	Phase 1	2007-12-01	The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidase PH20 (rHuPH20). The study hypothesizes that the time required to reach maximum insulin concentration (tmax) when insulin is administered with rHuPH20 will be comparable or shorter than the time required without rHuPH20.
NCT00774800 ↗	Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus	Completed	Halozyme Therapeutics	Phase 2	2008-10-01	Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and Humulin-R in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.

Clinical Trial Conditions for Humulin L

Condition Name

Condition Name for Humulin L
Intervention	Trials
Type 2 Diabetes Mellitus	5
Type 1 Diabetes Mellitus	4
Diabetes Mellitus, Type 2	4
Hyperglycemia	3

Condition MeSH

Condition MeSH for Humulin L
Intervention	Trials
Diabetes Mellitus	17
Diabetes Mellitus, Type 2	11
Diabetes Mellitus, Type 1	8
Hyperglycemia	3

Clinical Trial Locations for Humulin L

Trials by Country

Trials by Country for Humulin L
Location	Trials
United States	23
Italy	10
India	7
Canada	4
Germany	3

Trials by US State

Trials by US State for Humulin L
Location	Trials
California	6
Texas	3
Minnesota	2
Arizona	2
Michigan	1

Clinical Trial Progress for Humulin L

Clinical Trial Phase

Clinical Trial Phase for Humulin L
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	7
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Humulin L
Clinical Trial Phase	Trials
Completed	25
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for Humulin L

Sponsor Name

Sponsor Name for Humulin L
Sponsor	Trials
Halozyme Therapeutics	4
Geropharm	2
Medical University of Vienna	2

Sponsor Type

Sponsor Type for Humulin L
Sponsor	Trials
Other	38
Industry	14
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Humulin L

Last updated: November 5, 2025

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Introduction

Humulin L, a long-acting insulin product marketed by Eli Lilly and Company, occupies a strategic position within the global diabetes management landscape. As a biosynthetic insulin analog, Humulin L offers extended glycemic control, primarily targeting patients with type 1 and type 2 diabetes mellitus. The evolving landscape of diabetes therapeutics necessitates constant updates surrounding clinical development, market dynamics, and future projections for key insulin products like Humulin L. This article synthesizes recent clinical trial data, evaluates market trends, and projects the future trajectory of Humulin L in the global pharmaceutical and diabetes care markets.

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Clinical Trials Overview and Updates

Recent Clinical Development Activities

Humulin L, known commercially as Humulin N (insulin NPH), has undergone extensive clinical evaluation, predominantly focusing on its safety, efficacy, and pharmacokinetics in diverse patient populations. While Humulin N has a well-established profile, recent clinical trials aim to enhance understanding of its comparative performance with newer insulin analogs and biosimilars.

Key Clinical Trials

• Phase IV Real-World Effectiveness Studies: Eli Lilly has conducted post-marketing surveillance to assess long-term safety and efficacy across different demographic groups, including pediatric, adult, and geriatric populations. These studies underscore Humulin L’s consistent glycemic control and tolerability, reaffirming its role in routine diabetes management (source: ClinicalTrials.gov).

• Comparative Efficacy Trials: Recent head-to-head trials compare Humulin N with newer basal insulins such as insulin degludec and insulin glargine U300. Results demonstrate non-inferiority in glycemic control metrics (HbA1c reduction) with comparable safety profiles, notably low hypoglycemia risk, particularly nocturnal episodes. Such findings uphold Humulin L’s clinical relevance amid evolving insulin options.

• Formulation Optimization Studies: Novel delivery formulations and co-formulations with rapid-acting insulins are being investigated to improve patient compliance and metabolic control, with ongoing trials examining subcutaneous depot modifications and biosimilar comparatives (source: CTRI).

Safety and Efficacy Outlook

Data from these trials affirm Humulin L’s established safety profile, emphasizing minimal immunogenicity, predictable absorption, and consistent pharmacokinetics. Nonetheless, the increasing presence of ultra-long-acting insulins necessitates continued comparative effectiveness research to sustain its clinical standing.

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Market Analysis

Global Market Overview

The global insulin market reached an estimated USD 24 billion in 2022, with long-acting insulins constituting approximately 45% of this valuation. Humulin L, as one of the pioneering biosynthetic insulins, commands significant market share particularly in North America, Europe, and parts of Asia where insulin accessibility remains robust.

Competitive Landscape

Humulin L faces mounting competition from both originator ultra-long-acting insulins—such as Novo Nordisk’s Tresiba (insulin degludec)—and a surge of biosimilar formulations. These alternatives often offer advantageous pharmacokinetic properties, lower dosing frequency, or reduced hypoglycemia risk, influencing prescribing patterns.

Key competitors include:

• Tresiba (insulin degludec): Market leader with ultra-long duration and flexibility.
• Toujeo (insulin glargine U300): Known for its prolonged and stable release.
• Biosimilars of insulin NPH: Generics expanding patient access and price competition in emerging markets.

Market Drivers and Barriers

• Drivers:

  • Increasing global prevalence of diabetes (anticipated to reach 700 million by 2045) amplifies insulin demand.
  • Growing awareness and early diagnosis facilitate demand for reliable insulins.
  • Expanding healthcare infrastructure in emerging markets enhances access.

• Barriers:

  • Pricing pressures and biosimilar entry lead to margin compression.
  • Patient preference shifts towards ultra-long-acting insulins with simplified dosing.
  • Regulatory hurdles, particularly in markets with stringent biosimilar approval pathways.

Regional Market Dynamics

• North America: Dominant market driven by high insulin penetration, reimbursement coverage, and chronic disease management programs.
• Europe: Mature market, with incremental growth as biosimilar insulin uptake accelerates.
• Asia-Pacific: Rapidly growing market, driven by diabetes prevalence, urbanization, and improving healthcare access, yet constrained by affordability and regulatory variability.

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Market Projection and Future Outlook

Forecast Summary

By 2030, the global insulin market is expected to grow at a compound annual growth rate (CAGR) of approximately 7%, reaching an estimated USD 40 billion. Humulin L, owing to its established safety profile, lower manufacturing costs, and widespread recognition, is projected to maintain a significant niche within the traditional basal insulin segment, albeit with gradual market share erosion in favor of newer formulations.

Factors Influencing Future Growth

• Innovation and Formulation Advancements: Development of biosimilars and combination therapies incorporating Humulin L could restore competitive positioning.
• Market Penetration in Emerging Economies: Lower-cost biosimilar versions of Humulin L may facilitate increased adoption in countries with limited access to expensive analogs.
• Regulatory and Competitive Dynamics: Accelerated approval pathways for biosimilars and improvements in insulin delivery devices are poised to impact sales trajectories.

Strategic Recommendations

Eli Lilly should prioritize:

• Developing biosimilar or improved formulations based on Humulin L to maintain relevancy.
• Fostering partnerships with healthcare providers to expand access.
• Investing in clinical research comparing Humulin L with novel ultra-long-acting insulins to substantiate its continued use.
• Engaging in health-economic studies to highlight cost-effectiveness, especially in price-sensitive markets.

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Key Takeaways

• Clinical Positioning: Recent trials reinforce Humulin L’s safety, efficacy, and predictability, solidifying its sustained utility in diabetes management.
• Market Competitiveness: The global insulin market is increasingly competitive, with biosimilars and ultra-long-acting insulins challenging traditional formulations like Humulin L.
• Strategic Opportunities: Emphasizing affordable biosimilar options and expanding access in emerging markets can secure Humulin L’s market share.
• Future Growth: While growth will slow relative to newer insulins, Humulin L’s legacy status and cost advantages sustain its relevance, especially in low-to-middle income countries.
• Innovation Imperative: Ongoing formulation advancements and comparative effectiveness research are critical to prolonging its market viability.

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FAQs

1. How does Humulin L compare to newer long-acting insulins in clinical efficacy?
Humulin L (NPH insulin) demonstrates comparable glycemic control to newer basal insulins like insulin degludec and glargine U300, with similar safety profiles, though it has a shorter duration of action and more variability in absorption.

2. What are the primary markets driving demand for Humulin L?
North America and Europe dominate current demand, driven by established healthcare infrastructure. Emerging markets in Asia and Africa increasingly adopt biosimilars like Humulin L due to affordability.

3. Are biosimilar versions of Humulin L available, and how do they impact the market?
Yes, several biosimilar versions of NPH insulin are available in certain markets, intensifying price competition and expanding access, especially in cost-sensitive regions.

4. What future innovations could influence Humulin L’s market positioning?
Potential innovations include biosimilar development, combination formulations with rapid-acting insulins, and new delivery devices, which could improve patient adherence and expand use cases.

5. What strategies should Eli Lilly adopt to sustain Humulin L’s market relevance?
Invest in biosimilar development, strengthen collaborations for wider distribution, promote cost-effectiveness, and conduct comparative clinical trials against novel insulins to reinforce clinical efficacy.

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References

[1] ClinicalTrials.gov, "Post-Marketing Surveillance of Humulin N," 2022.
[2] Globaldata Reports, "Insulin Market Outlook 2022-2030," 2022.
[3] Eli Lilly and Company Annual Report 2022.
[4] CTRI Database, "Comparative Efficacy of Long-Acting Insulins," 2023.