CLINICAL TRIALS PROFILE FOR HUMULIN U

All Clinical Trials for Humulin U

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 U

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Humulin U

Trials by Country

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

Trials by US State

Trials by US State for Humulin U
Location	Trials
California	6
Texas	3
Minnesota	2
Arizona	2
Massachusetts	1

Clinical Trial Progress for Humulin U

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Humulin U

Sponsor Name

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

Sponsor Type

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

Humulin R U-500: Clinical Trials, Market Analysis, and Projections

Introduction to Humulin R U-500

Humulin R U-500 is a highly concentrated insulin formulation developed by Eli Lilly and Company, designed for individuals with diabetes who require high doses of insulin. This insulin is five times more concentrated than the standard U-100 insulin, making it a crucial treatment option for those with high insulin requirements.

Clinical Trials and Efficacy

The VIVID Study

One of the most significant clinical trials involving Humulin R U-500 is the VIVID study. This phase 3, open-label, multicenter, parallel, randomized, controlled study evaluated the safety and efficacy of Humulin R U-500 delivered via Continuous Subcutaneous Insulin Infusion (CSII) compared to multiple daily injections (MDI) in adults with type 2 diabetes requiring high doses of insulin (201-600 units/day)[1][3].

Key findings from the VIVID study include:

• A1C Reduction: Humulin R U-500 administered via an investigational insulin pump (Omnipod® U-500™ Insulin Management System) resulted in greater A1C reduction (-1.27%) compared to MDI (-0.85%) at the primary endpoint of 26 weeks.
• Insulin Dosage: The study also showed that using the pump led to a lower total daily insulin dose compared to MDI, with a difference of -0.47 units/kg at the primary endpoint.
• Glycemic Control: Beginning at week eight, A1C improvement was greater with the pump compared to MDI, with a difference of -0.42% between treatment groups at the primary endpoint.

Real-World Outcomes

Real-world outcome analyses have also demonstrated the efficacy of Humulin R U-500. A study published in the BMJ showed that initiation of U-500R insulin was associated with clinically meaningful improvements in glycemic control over a 12-month period, although with a modest increase in the incidence and rate of hypoglycemia[4].

Market Analysis

Market Size and Growth

The human recombinant insulin market, which includes Humulin R U-500, 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][5].

Market Segmentation

The human recombinant insulin market is segmented by drug type, brand, and geography. Key segments include:

• Drug Type: Short-acting, intermediate-acting, and premixed human insulin.
• Brand: Humulin, Insuman, Novolin, and others.
• Geography: North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America.

Regional Insights

North America is expected to hold the largest market share due to the growing prevalence of diabetes in the U.S. and significant investments in medical research. The Asia-Pacific region is also projected to demonstrate rapid growth, driven by a high diabetic population in countries like India and China[2][5].

Distribution Channels

The market is segmented by distribution channels into hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies are forecasted to hold the major market share, followed by hospital pharmacies. Online pharmacies are expected to grow at the highest CAGR due to the rising popularity and convenience of online medicine purchases[5].

Projections and Future Outlook

Market Growth Drivers

The growth of the human recombinant insulin market, including Humulin R U-500, is driven by several factors:

• Increasing Prevalence of Diabetes: The rising global diabetic population, particularly in regions like Asia-Pacific, is a significant driver.
• Technological Advancements: Continuous advancements in insulin delivery systems, such as insulin pumps, enhance the efficacy and convenience of insulin therapy.
• Healthcare Expenditure: Increasing healthcare expenditure and better accessibility to insulin therapy are also contributing to market growth[2][5].

Challenges and Risks

Despite the positive projections, there are substantial risks and uncertainties associated with the development and commercialization of Humulin R U-500. These include:

• Regulatory Approvals: There is no guarantee that future study results will be consistent with current findings or that Humulin R U-500 will receive additional regulatory approvals.
• Commercial Success: The commercial success of Humulin R U-500 is subject to various market and economic factors[1][3].

Key Takeaways

• Clinical Efficacy: Humulin R U-500 has shown significant efficacy in reducing A1C levels and lowering daily insulin doses when administered via an insulin pump.
• Market Growth: The human recombinant insulin market, including Humulin R U-500, is expected to grow substantially, driven by increasing diabetes prevalence and technological advancements.
• Regional Dominance: North America and the Asia-Pacific region are key markets, with the latter expected to show rapid growth.
• Distribution Channels: Retail and online pharmacies are crucial distribution channels, with online pharmacies expected to grow at the highest CAGR.

FAQs

Q1: What is Humulin R U-500?

A1: Humulin R U-500 is a highly concentrated insulin formulation, five times more concentrated than standard U-100 insulin, designed for individuals with high insulin requirements.

Q2: What were the key findings of the VIVID study?

A2: The VIVID study showed that Humulin R U-500 administered via an insulin pump resulted in greater A1C reduction and lower total daily insulin doses compared to multiple daily injections.

Q3: How is the human recombinant insulin market segmented?

A3: The market is segmented by drug type (short-acting, intermediate-acting, premixed), brand (Humulin, Insuman, Novolin), and geography (North America, Europe, Asia-Pacific, etc.).

Q4: Which region is expected to show the most rapid growth in the human recombinant insulin market?

A4: The Asia-Pacific region is projected to demonstrate rapid growth due to a high diabetic population in countries like India and China.

Q5: What are the main distribution channels for human recombinant insulin?

A5: The main distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies, with online pharmacies expected to grow at the highest CAGR.

Sources

1. Eli Lilly and Company. First-ever Study of Lilly's Humulin® R U-500 Administered in an Insulin Pump Shows Improved A1C in People with Type 2 Diabetes. June 25, 2018.
2. Mordor Intelligence. Human Recombinant Insulin Market - Trends & Industry Analysis.
3. PR Newswire. First-ever Study of Lilly's Humulin® R U-500 Administered in an Insulin Pump Shows Improved A1C in People with Type 2 Diabetes. June 25, 2018.
4. BMJ. Initiation of human regular U-500 insulin use is associated with clinically meaningful improvement in glycemic control.
5. Global Market Estimates. Human Recombinant Insulin Market Insights.