CLINICAL TRIALS PROFILE FOR INSULIN RECOMBINANT HUMAN

505(b)(2) Clinical Trials for Insulin Recombinant Human

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.
New Combination	NCT00501709 ↗	Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus	Completed	University of California, San Francisco	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 Insulin Recombinant Human

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.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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 Insulin Recombinant Human

Condition Name

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

Condition MeSH

Condition MeSH for Insulin Recombinant Human
Intervention	Trials
Diabetes Mellitus	2438
Diabetes Mellitus, Type 2	1630
Diabetes Mellitus, Type 1	913
Insulin Resistance	563

Clinical Trial Locations for Insulin Recombinant Human

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Insulin Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Insulin Recombinant Human
Clinical Trial Phase	Trials
PHASE4	95
PHASE3	53
PHASE2	75

Clinical Trial Status

Clinical Trial Status for Insulin Recombinant Human
Clinical Trial Phase	Trials
Completed	3419
Recruiting	662
Unknown status	436

Clinical Trial Sponsors for Insulin Recombinant Human

Sponsor Name

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

Sponsor Type

Sponsor Type for Insulin Recombinant Human
Sponsor	Trials
Other	5759
Industry	2591
NIH	673

Clinical Trials Update, Market Analysis, and Projection for Insulin Recombinant Human

Last updated: October 30, 2025

Introduction

Recombinant human insulin (RHI), a bioengineered form of insulin synthesized via genetic recombination, remains a cornerstone in the management of diabetes mellitus. As the global diabetes epidemic accelerates, innovations and advancements in insulin formulations and delivery systems have propelled the market. This article provides a comprehensive update on ongoing clinical trials, current market dynamics, and future projections for recombinant human insulin, offering critical insights for stakeholders ranging from pharmaceutical companies to investors.

Clinical Trials Overview

Recent and Current Clinical Trials

Over the past year, numerous clinical trials have focused on enhancing the efficacy, safety, and patient compliance associated with recombinant human insulin. Notably, the emphasis remains on developing ultra-long-acting formulations, alternative delivery methods, and improved biosimilar options.

• Ultra-long-acting formulations: Several ongoing trials are evaluating insulin analogs such as insulin degludec and insulin glargine, with recombinant human insulin formulations being refined for extended action. For example, a phase 3 trial (NCT04578945) assessed a sustained-release recombinant human insulin, demonstrating promising pharmacokinetics suitable for once-daily dosing.1

• Inhalable and alternative delivery systems: Researchers are investigating inhalable recombinant human insulin (e.g., Afrezza), with mixed results regarding pulmonary safety and absorption. A recent phase 2 trial (NCT05012367) explored a dry powder recombinant human insulin inhaler, aiming to improve patient adherence.2

• Biosimilar development: Multiple trials are underway to establish biosimilar recombinant human insulin products, with regulator-approved candidates entering Phase 3 in markets such as the European Union and the U.S. (e.g., NCT04354321).3

Regulatory and Approval Status

The FDA approved several biosimilar recombinant human insulins, like Basaglar (insulin glargine) and Semglee (insulin glargine-yfgn), reflecting a competitive landscape driven by clinical efficacy data and manufacturing standards. Meanwhile, ongoing Phase 4 studies aim to gather real-world data on long-term safety and efficacy for these biosimilars.

Research Focus and Innovations

Advances include the engineering of recombinant human insulin with modified amino acid sequences for improved stability, faster onset, or prolonged duration. Additionally, there is a significant push toward developing biosimilar versions to reduce costs and expand accessibility, especially in emerging markets.

Market Analysis

Market Size and Growth Drivers

The global insulin market was valued at approximately $25.3 billion in 2022 and is projected to reach $45.0 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 7.1%.4 Major drivers include the rising prevalence of diabetes mellitus—estimated to affect 537 million adults worldwide—and the increasing adoption of insulin therapy for both type 1 and type 2 diabetes.

Key Market Players

Leading industry players include Novo Nordisk, Eli Lilly, Sanofi, Biocon, and emerging biosimilar manufacturers such as Biocon and Mylan. The competitive landscape now emphasizes biosimilar entries, which have gained regulatory approval following successful clinical trials demonstrating bioequivalence and safety.

Company	Product	Market Position	Key Developments
Novo Nordisk	NovoLog, Tresiba	Market leader	Focus on ultra-long-acting formulations
Eli Lilly	Humalog, Trulicity	Significant share	Expansion into biosimilars
Sanofi	Lantus, Toujeo	Well-established	Biosimilar entries and patent challenges
Biocon	INSUPen,drugbiosimilars	Growing presence	Clinical trials for biosimilar recombinant human insulin

Regional Market Dynamics

• North America: Dominates due to high diabetes prevalence, advanced healthcare infrastructure, and strong pharmaceutical innovation. The U.S. FDA’s expedited approval pathways significantly accelerate biosimilar market entries.

• Europe: A mature market with a focus on biosimilar adoption driven by cost containment policies and regulatory support.

• Asia-Pacific: Exhibits rapid growth, driven by increasing diabetic populations, increased healthcare spending, and local manufacturing capabilities, notably in India and China.

Market Challenges

Key hurdles include:

• Pricing and reimbursement policies: Variability across regions impacts market penetration of biosimilar recombinant human insulin.
• Patent litigations: Patent expirations often invite biosimilar entry, yet legal challenges occasionally delay commercialization.
• Patient acceptance: Concerns about biosimilar interchangeability and immunogenicity pose barriers.

Market Projection

Future Trends

• Biosimilar proliferation: Expected to constitute 40-50% of the recombinant human insulin market by 2030, driven by cost competition.
• Technological innovation: Focus on needle-free delivery systems, implantable pumps, and inhalable formulations will diversify product pipelines.
• Personalized medicine: Use of pharmacogenomics and precision dosing is anticipated to optimize insulin therapy, enhancing market growth.

Revenue and Market Share Outlook

By 2030, the global recombinant human insulin market is forecast to reach $45 billion, driven predominantly by biosimilar adoption and innovations in delivery. North America will retain the largest market share (~45%), followed by Europe (~25%) and Asia-Pacific (~20%).

Regional Growth Strategies

Manufacturers targeting emerging markets should invest in local production, regulatory engagement, and patient education to capture expanding diabetic populations. Conversely, established players in mature markets will focus on biosimilar differentiation and technology upgrades.

Conclusion

Recombinant human insulin remains a vital therapeutic agent amid fierce competition from insulin analogs and biosimilars. Recent clinical trials highlight ongoing efforts to improve pharmacokinetics, administration routes, and affordability. The market is poised for robust growth, with biosimilar proliferation and technological innovations propelling expansion. Stakeholders should adapt to regulatory landscapes, focus on personalized delivery solutions, and capitalize on emerging markets to sustain growth.

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Key Takeaways

• Continuous clinical trials focus on ultra-long-acting formulations, inhalable options, and biosimilar development to improve patient outcomes and reduce costs.
• The global insulin market is expected to nearly double by 2030, driven by rising diabetes prevalence and biosimilar adoption.
• Major players are investing heavily in biosimilar pipelines, with regulatory approvals increasing access and competition.
• Geographic dynamics underscore the importance of tailored strategies; North America and Europe lead, while Asia-Pacific offers significant growth opportunities.
• Innovations such as needle-free delivery systems and personalized dosing are set to transform insulin therapy over the next decade.

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FAQs

1. What are the recent breakthroughs in recombinant human insulin formulations?
Recent advances include the development of ultra-long-acting insulin analogs with extended pharmacokinetics, inhalable recombinant human insulin formulations, and biosimilar versions that offer cost-effective alternatives to originator products.

2. How competitive is the recombinant human insulin market?
Highly competitive, dominated by large pharmaceutical companies like Novo Nordisk, Eli Lilly, and Sanofi, with a growing number of biosimilar manufacturers entering the space, driven by patent expirations and regulatory approvals.

3. What role do biosimilars play in the future of recombinant human insulin?
Biosimilars are expected to significantly increase market accessibility by offering cost-effective options, accounting for about 40-50% of the insulin market share by 2030, thus broadening patient access worldwide.

4. Which regions are experiencing the fastest growth in recombinant insulin demand?
The Asia-Pacific region is seeing rapid growth due to increasing diabetes prevalence, expanding healthcare infrastructure, and local manufacturing capabilities.

5. What upcoming innovations could reshape the delivery of recombinant human insulin?
Emerging technologies include needle-free injectors, inhalable formulations, implantable pumps, and personalized dosing systems, all aimed at improving compliance and outcomes.

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References

1. ClinicalTrials.gov. (2022). Phase 3 trial of sustained-release recombinant human insulin. NCT04578945.
2. ClinicalTrials.gov. (2023). Inhalable dry powder recombinant human insulin trial. NCT05012367.
3. European Medicines Agency. (2022). Biosimilar insulin approval updates.
4. MarketWatch. (2023). Global Insulin Market Size and Forecast.