CLINICAL TRIALS PROFILE FOR HUMULIN BR

All Clinical Trials for Humulin Br

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.

Clinical Trial Conditions for Humulin Br

Condition Name

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

Condition MeSH

Condition MeSH for Humulin Br
Intervention	Trials
Diabetes Mellitus	17
Diabetes Mellitus, Type 2	11
Diabetes Mellitus, Type 1	7
Hyperglycemia	3

Clinical Trial Locations for Humulin Br

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Humulin Br

Clinical Trial Phase

Clinical Trial Phase for Humulin Br
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Humulin Br
Clinical Trial Phase	Trials
Completed	25
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Humulin Br

Sponsor Name

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

Sponsor Type

Sponsor Type for Humulin Br
Sponsor	Trials
Other	37
Industry	14
NIH	1

Humulin: Clinical Trials, Market Analysis, and Projections

Introduction to Humulin

Humulin, developed by Eli Lilly and Company, is a human recombinant insulin produced through recombinant DNA technology. It was the first marketable product created using this technology and has been a cornerstone in the treatment of diabetes since its introduction.

Clinical Trials and Development

Historical Context

Humulin was first approved by the FDA in 1982 and has since become a widely used insulin therapy. It is synthesized in a non-disease-producing laboratory strain of E. coli bacteria, making it structurally identical to human insulin[2].

Current Clinical Landscape

While Humulin itself is not in new clinical trials, the broader landscape of insulin therapies is evolving rapidly. For instance, numerous clinical trials are ongoing for new antidiabetic agents, including novel insulin analogues and combination therapies. These trials often involve new molecular targets and combination regimens that may offer improved glucose control and additional benefits such as weight loss and reduced cardiovascular risk[1].

Market Analysis

Global Market Size and Growth

The human recombinant insulin market, which includes Humulin, is projected to grow significantly. By 2025, the market is expected to reach USD 29.30 billion and is anticipated to grow at a CAGR of greater than 2.9% to reach USD 33.80 billion by 2030[2].

Regional Market Dynamics

North America currently holds the largest market share in the human recombinant insulin market, while the Asia Pacific region is expected to be the fastest-growing market over the forecast period. This growth is driven by increasing healthcare expenditure and the rising prevalence of diabetes in these regions[2].

Market Segmentation

The human recombinant insulin market is segmented by drug type (short-acting, intermediate-acting, and premixed human insulin), brand (including Humulin, Insuman, Novolin, and others), and geography. Humulin, being one of the pioneering brands, continues to be a significant player in this market[2].

Key Players and Market Competition

Major Market Players

The human recombinant insulin market is dominated by several key players, including Novo Nordisk A/S, Eli Lilly and Company, Sanofi S.A., Biocon, and Zhuhai United Laboratories Co., Ltd. These companies are continuously innovating and expanding their product portfolios to meet the growing demand for insulin therapies[2].

Competitive Advantage of Humulin

Humulin's long-standing presence and wide acceptance in the market contribute to its competitive advantage. It is available in various formulations, such as Humulin R U-500, which has a higher concentration of insulin, and Humulin N, which has a slower onset and longer duration of action. This versatility makes Humulin a preferred choice for many patients and healthcare providers[2].

Projections and Future Outlook

Market Growth Projections

The North America insulin market, which includes Humulin, generated a revenue of USD 8,664.8 million in 2024 and is expected to grow at a CAGR of 2.3% from 2025 to 2030, reaching USD 9,510.3 million by 2030. The insulin analog segment, which includes advanced formulations of Humulin, is expected to be the fastest-growing segment during this period[5].

Emerging Trends

The market is witnessing a shift towards more personalized and accessible treatments for diabetes. New drug combinations and novel molecular targets are being explored, which may complement or even surpass traditional insulin therapies like Humulin in the future. However, Humulin's established reputation and continuous improvements in its formulations are likely to keep it a significant player in the market[1].

Cost and Accessibility

Out-of-Pocket Costs

The average out-of-pocket spending for Humulin R U-500 by Medicare Part D enrollees was USD 116, highlighting the ongoing need to manage the cost of insulin therapies. Efforts to make these treatments more affordable are crucial for increasing accessibility, especially in developing economies[2].

Conclusion

Humulin remains a cornerstone in the treatment of diabetes, with a strong market presence and ongoing demand. As the human recombinant insulin market continues to grow, driven by increasing healthcare expenditure and the rising prevalence of diabetes, Humulin is poised to remain a key player. However, the landscape is evolving with new clinical trials and innovative treatments, which may offer additional benefits and challenges in the future.

Key Takeaways

• Market Growth: The human recombinant insulin market is expected to reach USD 29.30 billion by 2025 and USD 33.80 billion by 2030.
• Regional Dynamics: North America holds the largest market share, while the Asia Pacific region is the fastest-growing.
• Competitive Advantage: Humulin's long-standing presence and versatility in formulations contribute to its market position.
• Future Outlook: The market is shifting towards more personalized and accessible treatments, with a focus on new drug combinations and novel molecular targets.
• Cost and Accessibility: Managing the cost of insulin therapies remains a critical issue for increasing accessibility.

FAQs

1. What is the projected market size for the human recombinant insulin market by 2030? The human recombinant insulin market is expected to reach USD 33.80 billion by 2030[2].

2. Which region is the fastest-growing in the human recombinant insulin market? The Asia Pacific region is expected to be the fastest-growing market over the forecast period[2].

3. What are the different formulations of Humulin available? Humulin is available in various formulations, including Humulin R U-500 and Humulin N, which have different onset and duration of action[2].

4. Who are the major players in the human recombinant insulin market? The major players include Novo Nordisk A/S, Eli Lilly and Company, Sanofi S.A., Biocon, and Zhuhai United Laboratories Co., Ltd.[2].

5. What is the average out-of-pocket spending for Humulin R U-500 by Medicare Part D enrollees? The average out-of-pocket spending for Humulin R U-500 by Medicare Part D enrollees was USD 116[2].

Sources

1. Frontiers in Pharmacology: Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New Combinations, and Novel Targets[1].
2. Mordor Intelligence: Human Recombinant Insulin Market - Trends & Industry Analysis[2].
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Meeting Documents[3].
4. Open Targets Platform: INSULIN HUMAN profile page[4].
5. Grand View Research: North America Insulin Market Size & Outlook, 2024-2030[5].

Last updated: 2025-01-07