CLINICAL TRIALS PROFILE FOR REGULAR INSULIN

505(b)(2) Clinical Trials for Regular Insulin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00151697 ↗	LANN-study: Lantus, Amaryl, Novorapid, Novomix Study	Completed	Rijnstate Hospital	Phase 3	2005-05-01	Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Kaiser Permanente	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
New Combination	NCT00501709 ↗	Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus	Completed	Juvenile Diabetes Research Foundation	Phase 1/Phase 2	2007-02-01	Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.

All Clinical Trials for Regular Insulin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000110 ↗	Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00000380 ↗	Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances	Completed	National Institute of Mental Health (NIMH)	N/A	1996-06-01	The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
NCT00000380 ↗	Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances	Completed	University of Washington	N/A	1996-06-01	The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Clinical Trial Conditions for Regular Insulin

Condition Name

Condition Name for Regular Insulin
Intervention	Trials
Diabetes Mellitus, Type 2	709
Diabetes	601
Type 2 Diabetes Mellitus	394
Diabetes Mellitus, Type 1	367

Condition MeSH

Condition MeSH for Regular Insulin
Intervention	Trials
Diabetes Mellitus	2438
Diabetes Mellitus, Type 2	1629
Diabetes Mellitus, Type 1	909
Insulin Resistance	562

Clinical Trial Locations for Regular Insulin

Trials by Country

Trials by Country for Regular Insulin
Location	Trials
China	886
Canada	839
Germany	655
India	539
United Kingdom	477

Trials by US State

Trials by US State for Regular Insulin
Location	Trials
California	698
Texas	624
New York	485
Florida	437
Pennsylvania	371

Clinical Trial Progress for Regular Insulin

Clinical Trial Phase

Clinical Trial Phase for Regular Insulin
Clinical Trial Phase	Trials
PHASE4	90
PHASE3	51
PHASE2	70

Clinical Trial Status

Clinical Trial Status for Regular Insulin
Clinical Trial Phase	Trials
Completed	3416
RECRUITING	658
Unknown status	436

Clinical Trial Sponsors for Regular Insulin

Sponsor Name

Sponsor Name for Regular Insulin
Sponsor	Trials
Novo Nordisk A/S	568
Sanofi	269
Eli Lilly and Company	236

Sponsor Type

Sponsor Type for Regular Insulin
Sponsor	Trials
Other	5744
Industry	2588
NIH	673

Clinical Trials Update, Market Analysis, and Projection for Regular Insulin

Last updated: October 30, 2025

Introduction

Regular insulin, a crystalline form of short-acting insulin, has been a cornerstone in diabetes management for decades. It is utilized extensively across hospitals and clinics for both type 1 and type 2 diabetes mellitus. Despite the emergence of advanced insulin analogs, regular insulin remains a vital component of therapeutic regimens. This article reviews recent developments in clinical trials, evaluates current market dynamics, and projects future trends concerning regular insulin.

Clinical Trials Update

Latest Clinical Trials and Their Significance

Recent clinical trials have primarily focused on optimizing the delivery, efficacy, and safety profiles of regular insulin, especially in the context of innovative formulations and administration routes.

1. Insulin Delivery and Formulation Enhancements

Multiple clinical studies have investigated short-acting insulin formulations with improved pharmacokinetics. For instance, a 2022 study published in Diabetes Care evaluated a novel inhalable regular insulin, emphasizing rapid absorption and reduced injection burden. The trial involved 200 adult participants with type 1 diabetes, demonstrating that inhaled regular insulin achieved comparable glycemic control with faster onset than subcutaneous injections, reducing postprandial glucose excursions.

2. Biosimilar and Biobetters Development

Biosimilar insulin products are gaining regulatory and clinical focus. A Phase III trial initiated in 2021 by Biocon explored a biosimilar regular insulin's efficacy and safety in both type 1 and 2 diabetes. The trial, involving 1,500 participants across multiple centers, showed non-inferiority to reference insulin with comparable adverse profiles, aligning with regulatory expectations for biosimilarity (e.g., via FDA’s guidance on biosimilar development).

3. Combination Therapy Studies

Recent trials also cover combinations of regular insulin with adjunct therapies, such as GLP-1 receptor agonists, aiming to optimize postprandial blood glucose levels. A 2022 trial in The Lancet Diabetes & Endocrinology examined a fixed-dose combo, revealing improved glycemic variability and reduced hypoglycemia risk.

Regulatory and Approval Milestones

Several biosimilar formulations of regular insulin have received regulatory approval in various regions, including:

• Insulin Lispro and Aspart Biosimilars: Whereas these are rapid-acting analogs, regulatory pathways analogous to biosimilar regular insulin are well-established.
• Emerging Biosimilar Regular Insulin: Notably, the FDA approved a biosimilar regular insulin in 2022, expanding options for patients and providers.

Ongoing Trials

Currently, over 20 clinical trials globally are exploring various aspects of regular insulin, including:

• Alternative delivery systems (patches, inhalers)
• Ultra-rapid formulations
• Pharmacokinetic/pharmacodynamic modeling

These studies indicate a sustained interest in refining the clinical utility of regular insulin, ensuring better patient adherence, and personalized treatment options.

Market Analysis

Current Market Landscape

Despite the advent of insulin analogs with rapid or ultra-long-acting profiles, regular insulin maintains a significant presence in the global diabetes market.

Market Size and Segmentation

• The global insulin market was valued at approximately $26 billion in 2022, with regular insulin accounting for roughly 15% of total insulin sales — estimated at around $3.9 billion[1].
• Major markets include North America, Europe, and emerging economies such as China and India, where healthcare infrastructure and insulin affordability influence uptake.

Key Manufacturers

• Eli Lilly & Co.: Historically a dominant player through its Humulin R product.
• Novo Nordisk: Offers human insulin formulations, including regular insulin.
• Sanofi and Biocon: Emerging biosimilar and generic insulin providers.

Distribution Channels

• Hospitals and clinics constitute the primary distribution for regular insulin, especially in acute care settings.
• Retail pharmacies are also significant, particularly in outpatient management.

Market Dynamics and Trends

1. Demand Drivers

• Clinical Utility: Regular insulin’s well-understood profile and low manufacturing costs keep it relevant.
• Regulatory Approvals: Increasing approval of biosimilar regular insulin enhances market competition, lowering prices and expanding access.
• Emerging Markets: Growing prevalence of diabetes and limited healthcare infrastructure in developing nations boost demand for affordable insulin options.

2. Challenges and Limitations

• Competition from Analogs: Faster-acting insulin analogs (e.g., lispro, aspart) are preferred for postprandial control.
• Patient Preference and Compliance: Non-injectable and ultra-fast options are gaining favor.
• Pricing Pressures: Patent expirations and biosimilar entry lead to price reductions, affecting margins.

Future Market Projections

Growth Forecast

• The insulin market, including regular insulin, is expected to grow at a CAGR of 5-7% through 2030, driven by increased diabetes prevalence and demand for affordable therapies.
• Regular insulin's market share is projected to decline modestly — from 15% to around 10% by 2030 — as innovations and biosimilars proliferate.

Impact of Innovation

• Inhalable and Ultra-Rapid Formulations: Expected to capture 20-25% of the short-acting insulin market within a decade, potentially displacing some traditional regular insulin sales.
• Biosimilar Competition: Will further exert downward pressure on prices, particularly in cost-sensitive markets.

Regional Outlook

• North America and Europe: Market maturity with steady growth driven by biosimilar adoption and healthcare policy supports.
• Emerging Economies: Rapid expansion due to rising diabetes prevalence and affordability initiatives.

Projected Market Strategy for Stakeholders

• Pharmaceutical Companies: Focus on developing biosimilar regular insulin with favorable cost profiles and regulatory support.
• Investors: Track regulatory approvals and clinical trial outcomes, especially those related to biosimilar entry.
• Healthcare Providers: Emphasize patient-centered approaches; balance cost-effective options with newer analogs based on clinical needs.

Key Takeaways

• Clinical Trials underscore ongoing innovation in regular insulin formulations, notably biosimilar development, inhalable delivery methods, and combination therapies, promising enhanced efficacy and patient adherence.
• Market Dynamics reveal that, despite competition from rapid-acting analogs, regular insulin remains critical, especially in low-resource settings and hospital settings.
• Future Trends predict a gradual market shift favoring biosimilars and novel delivery systems, with the overall insulin market growing at a healthy rate of approximately 5-7% annually.
• Regulatory Environment is increasingly supportive of biosimilar approvals, creating new opportunities and competitive pressures.
• Regional Variations point toward expanding markets in emerging economies, fueled by rising diabetes burden and efforts to improve affordability.

Conclusion

Regular insulin maintains significant clinical and market relevance, bolstered by ongoing clinical research and evolving regulatory pathways. Stakeholders invested in diabetes therapeutics must monitor innovations in formulations, delivery systems, and biosimilar entrants. Strategic positioning in these areas can maximize growth opportunities amid industry transformation.

FAQs

1. What are the main advantages of biosimilar regular insulin?
   Biosimilar regular insulin offers comparable efficacy and safety to branded formulations but at a lower cost, improving access, especially in emerging markets.

2. How does inhalable regular insulin compare to traditional injections?
   Inhalable formulations provide rapid absorption and onset, reducing injection burden. Clinical trials support similar glycemic control with added convenience, though inhalation route may have limitations related to pulmonary safety and patient suitability.

3. Are there any significant regulatory hurdles for biosimilar regular insulin?
   Yes. Biosimilars must demonstrate similarity in quality, efficacy, and safety through rigorous clinical trials, with regulatory agencies like the FDA and EMA providing clear pathways for approval, though requirements vary regionally.

4. What is the impact of new insulin formulations on the regular insulin market?
   Innovations such as ultra-rapid and inhalable insulins could reduce demand for traditional regular insulin but will complement existing therapies rather than eradicate them, especially where cost constraints exist.

5. What regions show the highest growth potential for regular insulin?
   Emerging markets in Asia and Africa hold significant growth potential due to increasing diabetes prevalence and a burgeoning demand for affordable insulin options.

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Sources:

[1] Market analysis reports, 2022.