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Last Updated: November 7, 2025

CLINICAL TRIALS PROFILE FOR INSULIN HUMAN


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505(b)(2) Clinical Trials for INSULIN 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for INSULIN 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for INSULIN HUMAN

Condition Name

Condition Name for INSULIN HUMAN
Intervention Trials
Diabetes Mellitus, Type 2 709
Diabetes 601
Type 2 Diabetes Mellitus 394
Diabetes Mellitus, Type 1 367
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Condition MeSH

Condition MeSH for INSULIN HUMAN
Intervention Trials
Diabetes Mellitus 2437
Diabetes Mellitus, Type 2 1627
Diabetes Mellitus, Type 1 906
Insulin Resistance 558
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Clinical Trial Locations for INSULIN HUMAN

Trials by Country

Trials by Country for INSULIN HUMAN
Location Trials
China 885
Canada 839
Germany 654
India 539
United Kingdom 477
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Trials by US State

Trials by US State for INSULIN HUMAN
Location Trials
California 698
Texas 624
New York 485
Florida 437
Pennsylvania 371
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Clinical Trial Progress for INSULIN HUMAN

Clinical Trial Phase

Clinical Trial Phase for INSULIN HUMAN
Clinical Trial Phase Trials
PHASE4 88
PHASE3 51
PHASE2 67
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Clinical Trial Status

Clinical Trial Status for INSULIN HUMAN
Clinical Trial Phase Trials
Completed 3416
Recruiting 656
Unknown status 436
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Clinical Trial Sponsors for INSULIN HUMAN

Sponsor Name

Sponsor Name for INSULIN HUMAN
Sponsor Trials
Novo Nordisk A/S 568
Sanofi 269
Eli Lilly and Company 236
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Sponsor Type

Sponsor Type for INSULIN HUMAN
Sponsor Trials
Other 5733
Industry 2584
NIH 671
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Insulin Human: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Insulin Human, a recombinant form of insulin synthesized for therapeutic use, maintains its pivotal role in diabetes management. As a bioengineered growth hormone, it continues to evolve through ongoing clinical evaluations, regulatory endorsements, and market dynamics. This report synthesizes recent clinical trial developments, markets landscape, and future growth projections, offering a comprehensive overview for stakeholders leveraging insights into the insulin market.


Clinical Trials Update for Insulin Human

Recent Developments and Ongoing Studies

Over the past year, clinical research for Insulin Human has focused on optimizing delivery mechanisms, safety profiles, and therapeutic efficacy. Several notable milestones include:

  • Phase III Trials of Ultra-Long Acting Insulin Analogues: Multiple studies compare the efficacy of Insulin Human in ultra-long-acting formulations versus existing insulin analogs, assessing fasting glucose control and hypoglycemia risk. Results from these trials demonstrate comparable or superior efficacy with favorable safety profiles, bolstering approvals for advanced formulations.

  • Biosimilar Development: Several pharmaceutical companies are conducting biosimilar trials of Insulin Human, aiming to reduce costs and improve access. These studies evaluate pharmacokinetics, immunogenicity, and non-inferiority relative to originator products. Positive outcomes have led to regulatory submissions in key markets such as the EU and India.

  • Sustained-Release and Closed-Loop Systems: Integration with insulin pump technology and cellular interface systems is under active investigation, seeking to enhance automation in diabetes management. Early-phase clinical trials report promising results in maintaining glycemic stability with reduced patient intervention.

Regulatory and Market Approvals

Recent approvals include:

  • FDA and EMA Approvals: Certain generic formulations and biosimilars of Insulin Human have secured approval, promoting broader accessibility, especially in emerging markets.

  • Equivalence and Interchangeability Designations: Regulatory agencies are increasingly recognizing biosimilar Insulin Human products as interchangeable, boosting market confidence and prescribing flexibility.

Challenges in Clinical Advancement

Despite promising signals, challenges persist:

  • Immunogenicity Concerns: Variability in immune responses remains a core concern for biosimilars; ongoing trials rigorously evaluate this aspect.

  • Delivery Innovation: The transition to minimally invasive, smart-injection devices requires extensive validation to meet safety and efficacy benchmarks.


Market Analysis of Insulin Human

Global Market Overview

The insulin market, globally valued at approximately USD 24.3 billion in 2022[1], continues to expand driven by rising diabetes prevalence. Insulin Human remains a substantial segment due to its cost-effectiveness and well-established manufacturing processes.

Market Segmentation and Dynamics

  • Traditional Insulin Market: Insulin Human dominates the baseline segment, favored for its biosimilar options, especially in price-sensitive markets such as India, China, and parts of Latin America.

  • Premium Insulin Segment: Longer-acting, analog-based insulins (e.g., insulin glargine, degludec) command higher margins, but Insulin Human is often prescribed as a first-line therapy in resource-limited settings.

Regional Landscape

  • North America: Largest market share, driven by high diabetes prevalence (over 34 million Americans with diagnosed diabetes[2]) and advanced healthcare infrastructure. The U.S. accounts for nearly 50% of global insulin sales.

  • Europe: Rapid adoption of biosimilars has increased access, with regulatory bodies facilitating generic entries.

  • Asia-Pacific: Rapid market growth, forecasted to expand at a CAGR of 9% through 2030, attributed to increasing healthcare expenditure and diabetes prevalence.

  • Emerging Markets: Cost considerations favor the proliferation of Biosimilar Insulin Human, supported by governmental policies to reduce healthcare expenditure.

Key Market Drivers

  • Rising diabetes incidence globally, projected to reach 700 million cases by 2045[3].

  • Increasing adoption of biosimilars to address high drug costs and improve accessibility.

  • Policy reforms encouraging biosimilar use to reduce healthcare expenditure.

Market Challenges

  • Patent expirations hinge on biosimilar entry, but regulatory hurdles and manufacturing complexities impede swift market penetration.

  • Competition from innovative insulin analogs with improved pharmacokinetics.

  • Price-sensitive markets face persistent challenges due to price wars and market saturation of biosimilars.


Market Projections for Insulin Human (2023-2030)

Growth Forecasts

The insulin market, with Insulin Human as a core component, is expected to grow at a CAGR of approximately 7.5% between 2023 and 2030[4]. This is driven by:

  • Expanding global diabetic population.

  • Increasing healthcare investments in biosimilar insulin development.

  • Policy shifts favoring affordable biosimilar insulins.

Future Market Opportunities

  • Biosimilar Expansion: As patent protections cease, biosimilar Insulin Human products are likely to increase market share, especially in cost-sensitive regions.

  • Digital Integration: Combining Insulin Human with smart delivery devices and continuous glucose monitoring (CGM) systems offers potential for personalized therapy.

  • Strategic Collaborations: Partnerships between originator companies and biosimilar manufacturers may accelerate access and adoption.

Risks and Uncertainties

  • Regulatory delays or rejections.

  • Market penetration barriers owing to entrenched preferences for insulin analogs.

  • Immunogenicity and safety perceptions influencing prescriber confidence.


Key Takeaways

  • Clinical Progress: Recent trials underscore the ongoing innovation in Insulin Human formulations, focusing on long-acting, biosimilar, and integrated delivery systems. These developments aim to improve efficacy, safety, and patient compliance.

  • Market Dynamics: The insulin market remains highly competitive, with biosimilar entries expanding access and pressuring prices. Geographic disparities influence growth trajectories, with emerging markets presenting lucrative opportunities.

  • Growth Outlook: Driven by the rising global diabetic burden and policy support for biosimilars, insulin Human is poised for sustained growth, especially in cost-sensitive regions. Technological integration with digital health platforms further enhances its future relevance.

  • Strategic Implications: Stakeholders should monitor regulatory pathways and technological advancements to optimize product portfolio strategies. Emphasizing safety, bioequivalence, and accessibility remains central.


FAQs

1. How does Insulin Human differ from insulin analogs?
Insulin Human is a recombinant, unmodified form of insulin with a molecular structure identical to endogenous human insulin. Insulin analogs are modified to alter absorption and action profiles, often resulting in faster or longer duration effects. While analogs offer flexible dosing, Insulin Human remains a cost-effective, reliable option, especially where biosimilar versions are available.

2. What are the main advantages of biosimilar Insulin Human products?
Biosimilars provide comparable efficacy and safety at lower costs, improving access for underserved populations. They foster competitive markets, reduce healthcare expenses, and align with regulatory standards for biosimilarity.

3. What regulatory hurdles do biosimilar Insulin Human products face?
Regulatory agencies require rigorous demonstration of biosimilarity, including extensive analytical, preclinical, and clinical data to establish equivalence in safety and efficacy. Immunogenicity assessment is critical, and regional approval processes may differ.

4. How is digital health impacting Insulin Human market prospects?
Integration with CGM devices and smart insulin delivery systems can enhance glycemic control, improve patient adherence, and reduce hypoglycemia. Companies investing in such technologies can differentiate their Insulin Human products and expand service offerings.

5. What is the future role of Insulin Human amid emerging therapies?
While innovative insulin analogs and non-insulin therapies continue to emerge, Insulin Human remains essential due to its affordability, manufacturing simplicity, and established clinical track record. Its role is likely to persist, especially in resource-limited settings, coupled with biosimilar proliferation and digital integration.


References

[1] International Diabetes Federation. (2022). Diabetes Atlas, 10th Edition.
[2] CDC. (2022). National Diabetes Statistics Report.
[3] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
[4] MarketWatch. (2023). Global Insulin Market Forecast, 2023-2030.

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