CLINICAL TRIALS PROFILE FOR HUMULIN R

All Clinical Trials for Humulin R

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 R

Condition Name

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

Clinical Trial Locations for Humulin R

Trials by Country

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

Trials by US State

Trials by US State for Humulin R
Location	Trials
California	6
Texas	3
Minnesota	2
Arizona	2
Nebraska	1

Clinical Trial Progress for Humulin R

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Humulin R

Sponsor Name

Sponsor Name for Humulin R
Sponsor	Trials
Halozyme Therapeutics	4
Mayo Clinic	2
Geropharm	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Forecast for Humulin R

Last updated: October 30, 2025

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Introduction

Humulin R, a recombinant human insulin product marketed primarily by Eli Lilly and Company, remains a cornerstone in diabetes management since its initial approval in the early 1980s. As a rapid-acting insulin analog, Humulin R shows efficacy in controlling postprandial blood glucose levels. This report provides a comprehensive review of recent clinical trial developments, current market dynamics, and future projections for Humulin R, informing stakeholders’ strategic decisions amid evolving diabetes therapy landscapes.

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Clinical Trials Update: Recent Developments and Future Directions

Ongoing Clinical Research and Emerging Data

Although Humulin R has a long-standing presence in the market, ongoing clinical trial activity focuses on optimizing its use, safety, and integration with novel insulin delivery systems. Recent notable trials include:

• Comparative Effectiveness Studies: Trials are examining Humulin R's performance against ultra-rapid and biosimilar insulins in diverse patient populations, emphasizing glycemic control and hypoglycemia risk management [1].

• Insulin Delivery Optimization: Trials investigating co-formulations of Humulin R with insulin analogs and advanced insulin pumps aim to improve adherence and reduce variability [2].

• Safety and Tolerability: Long-term safety studies continue to monitor hypoglycemia risk, antibody development, and potential adverse effects in different demographic groups, including pediatric and geriatric populations.

Regulatory and Labeling Updates

Recent regulatory reviews have reaffirmed Humulin R’s safety profile, with some updates advocating for its use within individualized treatment regimens. Notably, in 2022, the FDA emphasized the importance of patient education regarding hypoglycemia management with human insulin products, including Humulin R, due to its predictable pharmacokinetic profile [3].

Innovations in Formulation and Delivery

While no novel formulations of Humulin R have yet gained regulatory approval, research into biosimilar versions and improved delivery devices continues. These initiatives aim to enhance patient compliance, particularly among populations requiring multiple daily injections.

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Market Analysis

Current Market Scope and Competition

Humulin R’s global sales have traditionally been robust, accounting for a significant share within the human insulin market. However, rapid innovation in insulin formulations, including insulin analogs and ultra-rapid acting products, has introduced competitive pressure.

• Market Share: Despite competition, Humulin R maintains approximately 30-35% of the human insulin segment, particularly strong in regions with limited access to newer insulins, such as certain emerging markets [4].

• Pricing and Reimbursement: As a biosimilar to newer insulin analogs, Humulin R is positioned as a more cost-effective alternative, especially where healthcare policy emphasizes affordability.

• Distribution Channels: Its availability in both developed and developing nations ensures broad accessibility through pharmacies, healthcare institutions, and diabetes clinics.

Key Market Drivers

• Growing Diabetes Prevalence: The global prevalence of diabetes, estimated at over 537 million adults as of 2021 and projected to reach 700 million by 2045 [5], sustains demand for human insulin products.

• Cost-Effectiveness: In cost-constrained markets, Humulin R’s affordability sustains its relevance.

• Treatment Guidelines: Many international guidelines, including those by the ADA and EASD, recommend human insulin as a first-line basal or correction insulin therapy, reinforcing its market position.

Market Challenges

• Shift Towards Insulin Analogs: The preference for ultra-rapid and long-acting insulin analogs due to improved pharmacokinetics and reduced hypoglycemia risks could marginalize the traditional human insulin market.

• Patent Expirations and Biosimilars: While Lilly’s patents for Humulin R expired decades ago, the emergence of biosimilars increases price competition.

• Patient Preference and Innovation: Advances in device technology, including smart insulin pens and closed-loop systems, favor newer formulations and delivery methods.

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Market Projections and Future Outlook

Forecast for the Next 5-10 Years

Based on current trends, the market outlook for Humulin R is characterized by gradual stability supported by unmet needs in specific segments and regions:

• Market Stability with Decline in Premium Segments: While overall insulin markets are expanding, Humulin R’s share in highly competitive regions may stabilize or decline slightly as prescribers increasingly favor analogs.

• Growth in Emerging Markets: Particularly in Asia, Africa, and Latin America, affordability and regulatory approval continue to favor human insulins, supporting growth in these regions [6].

• Potential for Biosimilar Expansion: Entry of biosimilar formulations could lower prices further, capturing budget-conscious markets and expanding access.

Projected Revenue Trends

• Moderate Growth in Emerging Economies: Predicted annual growth rate of approximately 2-4% driven by increasing diabetes prevalence and healthcare infrastructure improvements.

• Plateau or Slight Decline in Advanced Markets: Mature regions may see a plateau or minor decline (-1 to 2%) due to competition from analogs and technological advances.

• Pricing Dynamics: Price erosion expected in competitive markets, but sustained demand for affordable human insulin will underpin sales, especially in public healthcare sectors.

Strategic Opportunities

• Combination Therapies: Developing fixed-dose combinations with insulin analogs could extend Humulin R’s market relevance.

• Enhanced Delivery Systems: Incorporation into user-friendly pens and integration with digital health solutions can improve adherence and clinician preferences.

• Market Penetration in underserved regions: Focused efforts to expand distribution and education in low-resource settings will optimize market utilization.

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Key Takeaways

• Clinical Development: Humulin R continues to be involved in research emphasizing safety, delivery optimization, and its role within combination regimens. No groundbreaking formulations appear imminent, but incremental improvements are ongoing.

• Market Position: Despite the rise of insulin analogs, Humulin R retains a vital niche rooted in affordability, regulatory acceptance, and supply chain robustness, especially in emerging markets.

• Future Outlook: The global insulin market will remain competitive, with Humulin R maintaining relevance through price advantages and expanded access, particularly where healthcare budgets constrain adoption of newer analogs.

• Strategic Focus: Manufacturers and stakeholders should prioritize biosimilar development, innovative delivery systems, and targeted outreach to underpenetrated regions to sustain and grow Humulin R’s market presence.

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FAQs

1. Will Humulin R be phased out in favor of insulin analogs?
Not immediately. While market trends favor analogs for their pharmacokinetics, Humulin R’s affordability and established safety profile ensure its continued use, especially in resource-limited regions.

2. Are there upcoming formulations or improvements planned for Humulin R?
Current focus is predominantly on biosimilar options and enhanced delivery devices; no major reformulations are publicly announced by Eli Lilly.

3. How does Humulin R compare to newer insulin products in terms of hypoglycemia risk?
Humulin R exhibits a predictable profile, but insulin analogs generally have a lower hypoglycemia risk, especially nocturnal events, due to their pharmacokinetic advantages.

4. What role does Humulin R play in pediatric and geriatric diabetes care?
Humulin R is widely used due to familiarity and cost-effectiveness, but its use is often tailored individually, balancing pharmacokinetics and patient-specific factors.

5. How do regulatory agencies view the safety of Humulin R?
Regulatory agencies such as FDA and EMA endorse Humulin R’s safety when used as indicated, emphasizing proper dosing and patient education to mitigate risks.

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References

[1] Clinical trial registry data, 2022.
[2] Insulin delivery optimization studies, 2021.
[3] FDA update on human insulin safety, 2022.
[4] Market share analysis reports, 2022.
[5] IDF Diabetes Atlas, 2021.
[6] WHO insulin access report, 2022.