CLINICAL TRIALS PROFILE FOR NOVOLIN R

All Clinical Trials for Novolin R

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00071448 ↗	Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population	Completed	Novo Nordisk A/S	Phase 3	2002-06-01	This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
NCT00487162 ↗	The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality	Terminated	University of Medicine and Dentistry of New Jersey	N/A	2007-06-01	Surgery induces a stress effect on the body partially through a catabolic energy state. In turn, glucose levels may rise to levels which have been associated with major morbidity (Golden, 1999) and mortality (Ouattara, 2005). An increasing body of evidence suggests that intensive insulin therapy for tight control of blood glucose levels in certain surgical and critical care patient populations may improve mortality and selected morbidity outcomes when compared to those patients receiving conventional insulin therapy and blood glucose management. More specifically, poor intra-operative blood glucose control is associated with worse outcome after cardiac surgery. Intensive insulin therapy with tight blood glucose control in surgical patients while in the ICU may reduce morbidity and mortality. Such outcome improvements would clearly provide benefits to patients, providers and payers. To date, there is scant research examining whether intensive insulin therapy for tight control of blood glucose in the perioperative period can alter outcomes for the non cardiac surgery population. The purpose of this study is to determine whether intensive insulin therapy for tight control of blood glucose in the perioperative period in non cardiac major surgery patients is associated with altered morbidity and mortality rates.
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).
NCT00593255 ↗	Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 4	2004-07-01	This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.
NCT00862875 ↗	Levemir-Body Composition and Energy Metabolism	Completed	McMaster University	Phase 4	2009-03-01	The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
NCT00862875 ↗	Levemir-Body Composition and Energy Metabolism	Completed	Novo Nordisk A/S	Phase 4	2009-03-01	The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .

Clinical Trial Conditions for Novolin R

Condition Name

Condition Name for Novolin R
Intervention	Trials
Type 2 Diabetes Mellitus	3
Type 1 Diabetes	2
Diabetes	2
Type 2 Diabetes	2

Condition MeSH

Condition MeSH for Novolin R
Intervention	Trials
Diabetes Mellitus	8
Diabetes Mellitus, Type 2	4
Diabetes Mellitus, Type 1	3
Hyperglycemia	2

Clinical Trial Locations for Novolin R

Trials by Country

Trials by Country for Novolin R
Location	Trials
United States	44
India	7
Italy	7
Canada	6
China	4

Trials by US State

Trials by US State for Novolin R
Location	Trials
California	3
Georgia	2
Utah	2
Texas	2
Pennsylvania	2

Clinical Trial Progress for Novolin R

Clinical Trial Phase

Clinical Trial Phase for Novolin R
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Novolin R
Clinical Trial Phase	Trials
Completed	9
Terminated	3
Withdrawn	1

Clinical Trial Sponsors for Novolin R

Sponsor Name

Sponsor Name for Novolin R
Sponsor	Trials
Novo Nordisk A/S	3
University of Calgary	2
University Health Network, Toronto	1

Sponsor Type

Sponsor Type for Novolin R
Sponsor	Trials
Other	10
Industry	6

Novolin R: Clinical Trials, Market Analysis, and Projections

Introduction to Novolin R

Novolin R is a short-acting insulin produced through recombinant DNA technology, used to treat type 1 and type 2 diabetes. It works by replacing the insulin that the body would normally produce, helping to regulate blood glucose levels and prevent complications associated with diabetes.

Clinical Trials and Efficacy

Comparative Studies with Humulin R

Clinical trials have compared the efficacy of Novolin R with Humulin R, another short-acting insulin. These studies have shown that both insulins are equally effective in managing blood glucose levels and have similar safety profiles. There was no significant difference in metrics such as HbA1c reduction or the incidence of hypoglycemic events between patients receiving Novolin R and those receiving Humulin R[1].

Studies with Other Insulins

A study comparing Novolin R with Novolog (another rapid-acting insulin) and Lispro showed that Novolog was statistically non-inferior to Novolin R but not non-inferior to Lispro in terms of HbA1c change from baseline. However, Lispro was found to be statistically superior to Novolin R in this context[4].

Adverse Reactions

Clinical trials have also documented the adverse reactions associated with Novolin R. In trials comparing Novolin R with insulin aspart in adults with type 1 and type 2 diabetes, common adverse reactions included hypoglycemia, which occurred in approximately 72% of patients in the Novolin R group[5].

Market Analysis

Global Human Insulin Market

The global human insulin market is expected to grow at a steady CAGR during the forecast period, driven by the increasing prevalence of diabetes worldwide. The market is segmented by indication (type 1 and type 2 diabetes), brand (including Novolin R, Humulin R, and others), route of administration, and type of insulin (basal, bolus, pre-mixed, etc.)[2].

Key Players and Market Size

The human recombinant insulin market, which includes Novolin R, is projected to reach $63,551.2 million by 2030, growing at a CAGR of 7.3% from 2022 to 2030. Major players in this market include Novo Nordisk A/S, Eli Lilly and Company, and Sanofi S.A.[3].

Regional Market Growth

The market growth is not uniform across regions. For instance, the human insulin market in Spain is expected to grow due to the increasing prevalence of diabetes and advancements in diabetes management. Similarly, the Japanese market is projected to grow with a CAGR of 6.17% through 2030[2].

Market Projections

Increasing Demand for Human Insulin

The demand for human insulin, including Novolin R, is anticipated to rise due to the growing number of diabetic patients globally. Diabetes is a chronic disorder that makes the body prone to various other diseases, emphasizing the importance of effective blood sugar control[2].

Technological Advancements

Advancements in diabetes management, such as the development of insulin pens, pumps, and other delivery systems, are expected to drive the market growth. These innovations make insulin administration more convenient and effective, contributing to the overall growth of the human insulin market[2].

Distribution and Administration

Routes of Administration

Novolin R is primarily administered subcutaneously, but the market also includes other routes such as nasal, intravenous, and oral administration for different types of insulins. The subcutaneous route remains the most common for short-acting insulins like Novolin R[2].

Products and Devices

The market includes various products such as insulin pens, pumps, and infusion systems that facilitate the administration of Novolin R and other insulins. These devices enhance patient compliance and improve the overall management of diabetes[2].

Growth Drivers and Challenges

Growth Drivers

• Increasing Prevalence of Diabetes: The rising number of diabetic patients worldwide is a significant driver for the human insulin market.
• Advancements in Technology: Improvements in insulin delivery systems and monitoring devices are making diabetes management more efficient.
• Global Health Initiatives: Increased focus on public health and diabetes management programs is driving the demand for human insulin[2][3].

Challenges

• Cost and Accessibility: High costs associated with insulin therapy can limit access, especially in developing countries.
• Regulatory Hurdles: Strict regulatory requirements can slow down the approval process for new insulin products.
• Competition: The market is highly competitive, with several brands and types of insulin available, which can affect market share[3].

Key Takeaways

• Efficacy and Safety: Novolin R has been shown to be as effective and safe as other short-acting insulins in clinical trials.
• Market Growth: The global human insulin market is expected to grow steadily due to the increasing prevalence of diabetes.
• Technological Advancements: Innovations in insulin delivery systems are driving market growth and improving patient outcomes.
• Regional Variations: Market growth varies by region, with significant growth expected in areas like Spain and Japan.

FAQs

What is Novolin R used for?

Novolin R is used to treat type 1 and type 2 diabetes by controlling high blood sugar levels and preventing associated complications[1].

How does Novolin R work?

Novolin R works by replacing the insulin that the body would normally produce, helping to regulate blood glucose levels and metabolize carbohydrates, fats, and proteins for energy[1].

What are the common adverse reactions associated with Novolin R?

Common adverse reactions include hypoglycemia, which is a significant concern in diabetes management[5].

How does the market for Novolin R look in the future?

The market for Novolin R and other human insulins is expected to grow due to the increasing prevalence of diabetes and advancements in technology[2][3].

What are the key drivers for the growth of the human insulin market?

Key drivers include the increasing prevalence of diabetes, technological advancements, and global health initiatives[2][3].

What challenges does the human insulin market face?

Challenges include high costs, regulatory hurdles, and intense competition within the market[3].

Sources

1. WithPower: Humulin R vs Novolin R | Power - Clinical Trials
2. TechSci Research: Human Insulin Market to Grow at a Steady CAGR until 2025
3. Coherent Market Insights: Human Recombinant Insulin Market Size and Forecast to 2030
4. FDA: STATISTICAL REVIEW AND EVALUATION
5. RxList: Novolin R (Recombinant DNA Origin) - RxList