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Last Updated: June 18, 2025

CLINICAL TRIALS PROFILE FOR INSULIN RECOMBINANT HUMAN


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Recombinant Human

Condition Name

Condition Name for Insulin Recombinant Human
Intervention Trials
Diabetes Mellitus, Type 2 689
Diabetes 585
Type 2 Diabetes Mellitus 386
Diabetes Mellitus, Type 1 360
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Condition MeSH

Condition MeSH for Insulin Recombinant Human
Intervention Trials
Diabetes Mellitus 2390
Diabetes Mellitus, Type 2 1540
Diabetes Mellitus, Type 1 861
Insulin Resistance 518
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Clinical Trial Locations for Insulin Recombinant Human

Trials by Country

Trials by Country for Insulin Recombinant Human
Location Trials
Canada 811
China 785
Germany 638
India 514
United Kingdom 466
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Trials by US State

Trials by US State for Insulin Recombinant Human
Location Trials
California 669
Texas 601
New York 467
Florida 424
Pennsylvania 359
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Clinical Trial Progress for Insulin Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Insulin Recombinant Human
Clinical Trial Phase Trials
Phase 4 1309
Phase 3 899
Phase 2/Phase 3 163
[disabled in preview] 1128
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Clinical Trial Status

Clinical Trial Status for Insulin Recombinant Human
Clinical Trial Phase Trials
Completed 3369
Recruiting 505
Unknown status 436
[disabled in preview] 650
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Clinical Trial Sponsors for Insulin Recombinant Human

Sponsor Name

Sponsor Name for Insulin Recombinant Human
Sponsor Trials
Novo Nordisk A/S 557
Sanofi 265
Eli Lilly and Company 230
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Sponsor Type

Sponsor Type for Insulin Recombinant Human
Sponsor Trials
Other 5346
Industry 2503
NIH 645
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Oral and Recombinant Human Insulin: Clinical Trials, Market Analysis, and Projections

Introduction to Human Insulin

Human insulin, particularly recombinant human insulin, has revolutionized the treatment of diabetes since its introduction in the 1980s. This synthetic insulin, produced using recombinant DNA technology, offers a safer and more reliable alternative to insulin derived from animal sources. Here, we will delve into the latest developments in oral insulin clinical trials, market analysis, and future projections for the human recombinant insulin market.

Clinical Trials Update: Oral Insulin

Human Trials in 2025

Researchers from UiT The Arctic University of Norway and the University of Sydney have made significant strides in developing an oral insulin that has shown promising results in animal models. This oral insulin is set to enter human clinical trials in 2025, led by the spin-out company Endo Axiom Pty Ltd[1].

Trial Phases and Objectives

The clinical trials will be conducted in three phases. Phase I will focus on the safety of the oral insulin and the incidence of hypoglycemia in both healthy and type 1 diabetic patients. The researchers aim to replicate the results seen in baboons, where the oral insulin showed no incidence of hypoglycemia. This phase is crucial for ensuring the safety of the drug for human use[1].

Potential Impact

If successful, this oral insulin could offer a more precise and convenient method of insulin delivery, avoiding the unwanted side effects associated with traditional injectable insulin. According to Peter McCourt, one of the study’s co-authors, "This way of taking insulin is more precise because it delivers the insulin rapidly to the areas of the body that need it most"[1].

Market Analysis: Human Recombinant Insulin

Market Size and Growth

The global human recombinant insulin market is experiencing significant growth. In 2023, the market size was valued at approximately USD 41.35 billion and is projected to reach USD 64.79 billion by 2030, growing at a CAGR of 8.25%[2].

Key Drivers

Several factors are driving this growth:

  • Increasing Prevalence of Diabetes: The rising number of diabetic patients globally is a major driver. By 2030, the number of adults with diabetes is expected to increase to 643 million[1][3].
  • Technological Advancements: Continuous improvements in insulin delivery systems, formulations, and monitoring technologies enhance patient convenience and compliance[3].
  • Healthcare Infrastructure Expansion: Improvements in healthcare infrastructure and favorable reimbursement policies across various regions are increasing patient access to insulin therapies[3].
  • Research and Development: Robust investments in R&D activities are driving the discovery of novel insulin formulations and delivery systems[3].

Distribution Channels

The market is segmented by distribution channels, with retail pharmacies expected to hold the highest share due to their growing adoption rate of human insulin delivery systems. Other significant channels include hospitals, online pharmacies, and others[2].

Regional Analysis

The global human recombinant insulin market is geographically segmented into North America, Europe, Asia Pacific, and the Rest of the world. North America is one of the largest growing regions, driven by advanced healthcare infrastructure and robust R&D activities. The Asia-Pacific region is also witnessing rapid growth due to the rising incidence of diabetes in countries like China and India[2][3].

Market Projections

Future Growth

By 2032, the global recombinant human insulin market is expected to reach approximately USD 55.99 billion, growing at a CAGR of 8.5% from 2023 to 2032[3].

Emerging Trends

  • Personalized Medicine: The shift towards personalized medicine is highlighting the importance of tailored treatment plans, which aligns with the customizable nature of recombinant human insulin[3].
  • Technological Innovations: Ongoing technological advancements in insulin delivery systems and monitoring technologies are expected to further drive market growth[3].

Key Players

The market is dominated by several key players, including:

  • Novo Nordisk A/S
  • Sanofi S.A.
  • Eli Lilly and Company
  • Medtronic plc.
  • Biocon Limited
  • Dongbao Enterprise Group Co., Ltd.
  • Zhuhai United Laboratories Co. Ltd.[5]

Challenges and Opportunities

Challenges

Despite the advancements, there are challenges such as economic barriers and limited access to advanced treatments in certain regions. For instance, in the Middle East and Africa, economic challenges can hinder widespread adoption of recombinant human insulin[3].

Opportunities

The growing geriatric population and increasing healthcare investments in emerging nations present significant opportunities for market expansion. Additionally, the potential success of oral insulin trials could open up new avenues for insulin delivery, enhancing patient compliance and convenience[1][3].

Key Takeaways

  • Oral Insulin Trials: Human clinical trials for oral insulin are set to begin in 2025, offering a potential game-changer in diabetes management.
  • Market Growth: The global human recombinant insulin market is projected to grow significantly, driven by increasing diabetes prevalence, technological advancements, and expanding healthcare infrastructure.
  • Regional Dynamics: North America and the Asia-Pacific region are expected to be key growth drivers due to their advanced healthcare systems and rising diabetes incidence.
  • Technological Innovations: Continuous R&D and technological advancements are crucial for market growth and patient convenience.
  • Personalized Medicine: The trend towards personalized medicine aligns with the customizable nature of recombinant human insulin.

FAQs

Q: When are the human clinical trials for oral insulin expected to start?

A: The human clinical trials for oral insulin are expected to start in 2025, led by the spin-out company Endo Axiom Pty Ltd[1].

Q: What is the projected market size of the global human recombinant insulin market by 2030?

A: The global human recombinant insulin market is projected to reach USD 64.79 billion by 2030, growing at a CAGR of 8.25% from 2024 to 2030[2].

Q: What are the key drivers of the global human recombinant insulin market?

A: Key drivers include the increasing prevalence of diabetes, technological advancements, healthcare infrastructure expansion, and robust R&D investments[2][3].

Q: Which regions are expected to be the largest growth drivers for the human recombinant insulin market?

A: North America and the Asia-Pacific region are expected to be the largest growth drivers due to their advanced healthcare systems and rising diabetes incidence[2][3].

Q: What is the potential impact of oral insulin on diabetes management?

A: Oral insulin could offer a more precise and convenient method of insulin delivery, avoiding the unwanted side effects associated with traditional injectable insulin[1].

Sources

  1. New Atlas: "Oral insulin set for human trials in 2025, may be available in 2-to-3 years"[1].
  2. Verified Market Research: "Human Recombinant Insulin Market Size & Forecast"[2].
  3. GlobeNewswire: "Latest Global Recombinant Human Insulin Market Size/Share"[3].
  4. BusinessWire: "China Recombinant Lispro Insulin Market Report 2021-2025"[4].
  5. Allied Market Research: "Human Recombinant Insulin Market Size, and Growth Report, 2033"[5].
Last updated: 2025-01-07

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