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.

Clinical Trial Conditions for Humulin R

Condition Name

Condition Name for Humulin R
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 R
Intervention	Trials
Diabetes Mellitus	17
Diabetes Mellitus, Type 2	11
Diabetes Mellitus, Type 1	7
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
Michigan	1

Clinical Trial Progress for Humulin R

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Humulin R

Sponsor Name

Sponsor Name for Humulin R
Sponsor	Trials
Halozyme Therapeutics	4
Biodel	2
Juvenile Diabetes Research Foundation	2

Sponsor Type

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

Humulin R: Clinical Trials, Market Analysis, and Projections

Introduction to Humulin R

Humulin R, developed by Eli Lilly and Company, is a human recombinant insulin that has been a cornerstone in the management of diabetes since its introduction. It is synthesized through recombinant DNA technology in a non-disease-producing laboratory strain of E. coli bacteria, making it structurally identical to human insulin[5].

Clinical Trials and Efficacy

Comparative Studies with Novolin R

Clinical trials have consistently shown that Humulin R and Novolin R, another regular insulin, have similar efficacy and safety profiles. Studies have demonstrated no significant difference between the two insulins in terms of HbA1c reduction or the incidence of hypoglycemic events. Both insulins are effective in managing high blood sugar levels, with a rapid onset of action starting within an hour after injection[4].

Use in Insulin Pumps

A significant study, known as the VIVID study, evaluated the use of Humulin R U-500 (a concentrated form of Humulin R) administered via an insulin pump (Omnipod® U-500™ Insulin Management System) compared to multiple daily injections (MDI). The study found that Humulin R U-500 delivered through the insulin pump resulted in greater A1C reduction and lower total daily insulin doses compared to MDI in adults with type 2 diabetes requiring high doses of insulin[1].

Market Analysis

Global Human Recombinant Insulin Market

The global human recombinant insulin market, which includes Humulin R, is projected to grow significantly. By 2025, the market size is estimated to reach USD 29.30 billion and is expected to grow at a CAGR of greater than 2.9% to reach USD 33.80 billion by 2030[5].

Market Segmentation

The human recombinant insulin market is segmented by product type, distribution channel, and region. The retail pharmacies segment is forecasted to hold the major market share, followed by hospital pharmacies. The online pharmacies segment is expected to grow at the highest CAGR due to the rising popularity and convenience of online medicine purchases[2].

Regional Insights

North America is expected to hold the largest market share in the human recombinant insulin market, driven by 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, attributed to a high diabetic population in countries such as India and China[2].

Brand Insights

Humulin, along with other brands like Insuman and Novolin, is a key player in the human recombinant insulin market. The increasing healthcare expenditure and better accessibility of Humulin are driving its demand. For instance, the average out-of-pocket spending by Medicare Part D enrollees per Humulin R U-500 was USD 116, indicating a significant market presence[5].

Distribution Channels

The distribution of Humulin R is primarily through hospital pharmacies, retail pharmacies, and increasingly through online pharmacies. The convenience and rising popularity of online medicine purchases are expected to boost the growth of the online pharmacies segment[2].

End-Use Landscape

The end-use landscape includes a wide range of consumers, from individual patients to healthcare institutions. Companies like LifePoint Health and Prime Healthcare Services are among the leading consumers of human recombinant insulin, including Humulin R[2].

Challenges and Opportunities

Challenges

Despite the growth prospects, the market faces challenges such as the rising cost of insulin, lack of awareness about diabetic conditions, and a rigid regulatory framework. Complications associated with insulin formulation and product recalls also pose significant challenges[3].

Opportunities

The rise in diabetes prevalence, especially in emerging countries, presents lucrative opportunities for the human recombinant insulin market. Improvements in healthcare facilities, strategic innovations by major players, and the use of in-vitro diagnostics for diabetic conditions are expected to bolster market growth[3].

Key Takeaways

• Clinical Efficacy: Humulin R has been shown to be as effective as other regular insulins in managing blood glucose levels, with no significant difference in HbA1c reduction or hypoglycemic events.
• Insulin Pump Use: The VIVID study demonstrated improved A1C reduction and lower insulin doses when Humulin R U-500 was administered via an insulin pump.
• Market Growth: The global human recombinant insulin market is expected to grow significantly, with North America holding the largest market share and the Asia Pacific region showing rapid growth.
• Distribution: The market is segmented by distribution channels, with retail pharmacies holding the major share and online pharmacies growing rapidly.
• Challenges and Opportunities: Despite challenges like rising costs and regulatory hurdles, the market is driven by increasing healthcare expenditure and improvements in healthcare facilities.

FAQs

What is the expected market size of the human recombinant insulin market by 2030?

The human recombinant insulin market is expected to reach USD 33.80 billion by 2030, growing at a CAGR of greater than 2.9% from 2025[5].

Which region holds the largest market share in the human recombinant insulin market?

North America holds the largest market share in the human recombinant insulin market, driven by the growing prevalence of diabetes and significant investments in medical research[2].

What are the key distribution channels for Humulin R?

The key distribution channels for Humulin R include hospital pharmacies, retail pharmacies, and online pharmacies, with the online segment expected to grow at the highest CAGR[2].

How does Humulin R compare to Novolin R in clinical trials?

Humulin R and Novolin R have been shown to have similar efficacy and safety profiles in clinical trials, with no significant difference in HbA1c reduction or hypoglycemic events[4].

What are the challenges facing the human recombinant insulin market?

The market faces challenges such as rising costs, lack of awareness about diabetic conditions, rigid regulatory frameworks, and complications associated with insulin formulation[3].

Sources

1. First-ever Study of Lilly's Humulin® R U-500 Administered in an Insulin Pump Shows Improved A1C in People with Type 2 Diabetes. Investor.lilly.com.
2. Global Human Recombinant Insulin - Market Analysis | Size. Globalmarketestimates.com.
3. Global Diabetic Hyperosmolar Syndrome Market – Global Industry Trends. Databridgemarketresearch.com.
4. Humulin R vs Novolin R | Power - Clinical Trials. Withpower.com.
5. Human Recombinant Insulin Market - Trends & Industry Analysis. Mordorintelligence.com.