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Last Updated: March 23, 2025

CLINICAL TRIALS PROFILE FOR INSULIN PURIFIED PORK


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505(b)(2) Clinical Trials for Insulin Purified Pork

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 Purified Pork

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 Purified Pork

Condition Name

Condition Name for Insulin Purified Pork
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 Purified Pork
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 Purified Pork

Trials by Country

Trials by Country for Insulin Purified Pork
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 Purified Pork
Location Trials
California 669
Texas 601
New York 467
Florida 424
Pennsylvania 359
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Clinical Trial Progress for Insulin Purified Pork

Clinical Trial Phase

Clinical Trial Phase for Insulin Purified Pork
Clinical Trial Phase Trials
Phase 4 1309
Phase 3 899
Phase 2/Phase 3 163
[disabled in preview] 2640
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Clinical Trial Status

Clinical Trial Status for Insulin Purified Pork
Clinical Trial Phase Trials
Completed 3369
Recruiting 505
Unknown status 436
[disabled in preview] 942
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Clinical Trial Sponsors for Insulin Purified Pork

Sponsor Name

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

Sponsor Type for Insulin Purified Pork
Sponsor Trials
Other 5346
Industry 2503
NIH 645
[disabled in preview] 95
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Oral and Traditional Insulin: Clinical Trials, Market Analysis, and Projections

Introduction to Insulin

Insulin, a hormone crucial for regulating blood sugar levels, has been a cornerstone in the management of diabetes for decades. The evolution of insulin from animal-derived to human insulin and now to innovative delivery methods like oral insulin is transforming the treatment landscape.

Clinical Trials Update: Oral Insulin

A significant development in the field of insulin therapy is the upcoming human clinical trials for oral insulin. Researchers from UiT The Arctic University of Norway and the University of Sydney have developed an oral insulin that has shown promising results in animal models, including mice, rats, and baboons. This oral insulin is set to enter human clinical trials in 2025, led by the spin-out company Endo Axiom Pty Ltd[1].

Key Findings in Animal Models

  • The oral insulin has been effective in reducing blood glucose levels without causing hypoglycemia in animal subjects.
  • In baboons, the treatment resulted in a 10% and 13% reduction in blood glucose levels with doses of 5 IU/kg and 10 IU/kg, respectively, with effects observable between 15 and 30 minutes[1].

Human Clinical Trials

  • The phase I trial will focus on the safety of the oral insulin and the incidence of hypoglycemia in both healthy and type 1 diabetic patients.
  • If successful, the oral insulin could offer a more practical, patient-friendly alternative to injections, as it does not require refrigeration and more closely mimics natural insulin release[1].

Traditional Insulin: Purified Pork Insulin

Before the advent of human insulin, purified pork insulin was widely used due to its lower antigenicity compared to beef insulin.

Historical Context

  • In the 1980s, the introduction of highly purified pork insulin by Novo Nordisk and the impending release of genetically engineered human insulin by Eli Lilly led to a significant reduction in the use of impure and beef insulins[2].

Clinical Efficacy

  • Studies have shown that purified pork insulin is as safe and efficacious as human insulin in treating insulin-dependent diabetes mellitus. A clinical trial comparing purified pork insulin with human insulin found no significant differences in fasting plasma glucose, glycohemoglobin levels, or the incidence of hypoglycemic reactions[4].

Market Analysis: Insulin Market

The insulin market is experiencing significant growth driven by several factors, including the increasing prevalence of diabetes and advancements in insulin technology.

Global Insulin Market Size and Growth

  • The global insulin market was estimated at USD 19.45 billion in 2024 and is projected to grow at a CAGR of 3.74% from 2025 to 2030[3].

Segment Analysis

  • The biosimilar insulin segment is expected to grow lucratively due to its cost-effectiveness and similar efficacy and safety profiles compared to branded insulins. This segment is driven by increasing demand for affordable diabetes management solutions and supportive regulatory frameworks[3].

Regional Market Trends

  • North America is projected to dominate the global human insulin market due to the high incidence of diabetes and a growing geriatric population. Europe and the Asia Pacific region are also expected to contribute significantly to the market growth[5].

Key Players

  • The insulin market is dominated by companies such as Novo Nordisk A/S, Eli Lilly and Company, Sanofi, Biocon, Ltd., and others. These companies are driving innovation with new insulin analogs and delivery devices[5].

Market Projections

Growth Drivers

  • The increasing prevalence of diabetes, projected to rise from 537 million in 2021 to 643 million by 2030, is a major driver of the insulin market[1].
  • The introduction of new insulin analogs and innovative delivery methods, such as the oral insulin and combination therapies like IcoSema, are expected to further fuel market growth[3].

Economic Impact

  • The insulin market in the United States alone grew at over 10% per year in the early 2000s, with sales projected to exceed $7.5 billion by 2020. Global sales for the largest manufacturers, including Novo Nordisk and Eli Lilly, have been in the billions annually[2].

Emerging Trends in Insulin Delivery

Oral Insulin

  • As mentioned, oral insulin is on the cusp of entering human clinical trials, offering a potential game-changer in diabetes management by eliminating the need for injections and providing a more discreet and patient-friendly option[1].

Combination Therapies

  • Novo Nordisk's IcoSema, a combination of basal insulin icodec and semaglutide, has shown promising results in reducing HbA1c levels and weight, while also reducing hypoglycemia incidents. This could streamline diabetes management by replacing daily injections with a single weekly dose[3].

Conclusion

The insulin market is poised for significant growth and innovation, driven by the increasing prevalence of diabetes and advancements in technology. The upcoming human clinical trials for oral insulin represent a promising development that could revolutionize diabetes treatment. Traditional purified pork insulin, while less common now, has a historical significance and clinical efficacy that underscores the evolution of insulin therapy.

Key Takeaways

  • Oral insulin is set to enter human clinical trials in 2025, offering a potential alternative to injections.
  • The global insulin market is projected to grow at a CAGR of 3.74% from 2025 to 2030.
  • Biosimilar insulins are expected to expand significantly due to their cost-effectiveness.
  • Combination therapies like IcoSema are streamlining diabetes management.
  • The market is dominated by key players such as Novo Nordisk and Eli Lilly.

FAQs

What is the current status of oral insulin trials?

Oral insulin trials are set to begin in human subjects in 2025, following successful tests in animal models.

How does oral insulin differ from traditional insulin?

Oral insulin is designed to be taken orally, eliminating the need for injections, and it more closely mimics natural insulin release, reducing the risk of hypoglycemia.

What are the key drivers of the insulin market growth?

The increasing prevalence of diabetes, advancements in insulin technology, and the introduction of cost-effective biosimilar insulins are major drivers.

Which companies dominate the insulin market?

Companies such as Novo Nordisk A/S, Eli Lilly and Company, Sanofi, and Biocon, Ltd. are key players in the insulin market.

What are the benefits of combination therapies like IcoSema?

Combination therapies like IcoSema reduce HbA1c levels, weight, and hypoglycemia incidents, and can replace daily injections with a single weekly dose.

Sources

  1. New Atlas: "Oral insulin set for human trials in 2025, may be available in 2-to-3 years"
  2. Diabetes Journals: "The Business of Insulin: A Relationship Between Innovation and..."
  3. Grand View Research: "Insulin Market Size, Share & Growth | Industry Report, 2030"
  4. PubMed: "Evaluation of efficacy and safety of human insulin (Novo..."
  5. BioSpace: "Human Insulin Market Size, Share, Emerging Trends, Analysis and Forecasts to 2026"

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