CLINICAL TRIALS PROFILE FOR INSULIN PURIFIED BEEF

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

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 Insulin Purified Beef

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 Insulin Purified Beef

Condition Name

Condition Name for Insulin Purified Beef
Intervention	Trials
Diabetes Mellitus, Type 2	689
Diabetes	585
Type 2 Diabetes Mellitus	386
Diabetes Mellitus, Type 1	360

Condition MeSH

Condition MeSH for Insulin Purified Beef
Intervention	Trials
Diabetes Mellitus	2390
Diabetes Mellitus, Type 2	1540
Diabetes Mellitus, Type 1	861
Insulin Resistance	518

Clinical Trial Locations for Insulin Purified Beef

Trials by Country

Trials by Country for Insulin Purified Beef
Location	Trials
Canada	811
China	785
Germany	638
India	514
United Kingdom	466

Trials by US State

Trials by US State for Insulin Purified Beef
Location	Trials
California	669
Texas	601
New York	467
Florida	424
Pennsylvania	359

Clinical Trial Progress for Insulin Purified Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Purified Beef
Clinical Trial Phase	Trials
Phase 4	1309
Phase 3	899
Phase 2/Phase 3	163

Clinical Trial Status

Clinical Trial Status for Insulin Purified Beef
Clinical Trial Phase	Trials
Completed	3369
Recruiting	505
Unknown status	436

Clinical Trial Sponsors for Insulin Purified Beef

Sponsor Name

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

Sponsor Type

Sponsor Type for Insulin Purified Beef
Sponsor	Trials
Other	5346
Industry	2503
NIH	645

The Evolution and Future of Insulin: Clinical Trials, Market Analysis, and Projections for Purified Beef Insulin

Introduction

Insulin, a cornerstone in the treatment of diabetes, has undergone significant transformations since its discovery nearly a century ago. From crude animal extracts to highly purified and recombinant forms, insulin therapy has evolved to meet the diverse needs of diabetic patients. This article delves into the clinical trials, market analysis, and future projections for purified beef insulin, a once dominant but now largely obsolete form of insulin therapy.

Historical Context of Insulin Therapy

Insulin was first isolated from animal pancreas in the early 20th century. Initially, it was derived from bovine (beef) and porcine (pork) sources. These early insulins were often contaminated with other pancreatic proteins, leading to immunogenic reactions and variable efficacy[3].

Clinical Trials on Purified Beef Insulin

Clinical trials in the 1980s and 1990s focused on the purification of beef insulin to reduce its immunogenicity. One study demonstrated that patients switched from conventional bovine insulin to highly purified bovine insulin experienced a significant reduction in insulin antibody levels. This purification reduced the incidence of lipoatrophy (fat loss at injection sites) and improved metabolic control without altering insulin doses[2].

Another study involved transferring patients from beef insulin to human insulin (produced through recombinant DNA technology) and purified beef insulin. The results showed no significant differences in metabolic control, including fasting and postprandial blood glucose levels, HbA1c, and daily insulin dosage. No severe hypoglycemic attacks or skin reactions were reported, indicating the safety and efficacy of purified beef insulin in comparison to human insulin[1].

Immunogenicity of Purified Beef Insulin

Despite purification efforts, beef insulin remains more immunogenic than human insulin. Studies have shown that even highly purified bovine insulin is associated with higher insulin antibody levels compared to human insulin. This immunogenicity can impact the long-term efficacy and safety of insulin therapy[2].

Market Analysis

The market for insulin has shifted significantly over the past few decades. With the advent of recombinant human insulin and insulin analogs, the demand for purified beef insulin has declined. Human insulin and its analogs offer better pharmacokinetic and pharmacodynamic profiles, closely mimicking the natural insulin response of the body. This has led to a preference for these newer forms of insulin among clinicians and patients[3].

Current Market Trends

• Human Insulin and Insulin Analogs: These have become the standard of care due to their reduced immunogenicity and improved action profiles.
• Biosimilar Insulins: The emergence of biosimilar insulins has further reduced the market share of purified beef insulin.
• Transgenic Insulin Production: Recent advancements in transgenic cows producing human insulin in their milk may revolutionize insulin production, potentially making traditional methods obsolete[4][5].

Future Projections

Given the current trends and advancements, the future of purified beef insulin looks bleak.

Decline in Use

• The continued preference for human insulin and insulin analogs due to their superior safety and efficacy profiles will likely lead to a further decline in the use of purified beef insulin.
• Regulatory approvals and market acceptance of new insulin production methods, such as transgenic cows, could accelerate this decline.

Technological Advancements

• Transgenic cows producing human insulin in their milk represent a promising future for insulin production. This method could offer a more efficient, cost-effective, and scalable solution, potentially eliminating the need for traditional animal-derived insulins[4][5].

Market Competition

• The insulin market is highly competitive, with major pharmaceutical companies investing heavily in recombinant human insulin and insulin analogs. This competition will continue to push purified beef insulin to the periphery.

Key Takeaways

• Clinical Efficacy: Purified beef insulin has shown comparable efficacy to human insulin in clinical trials but remains more immunogenic.
• Market Trends: The market is shifting towards human insulin and insulin analogs due to their superior profiles.
• Future Outlook: The emergence of transgenic cows producing human insulin may revolutionize insulin production, making purified beef insulin obsolete.
• Technological Advancements: New production methods could offer more efficient and cost-effective solutions, further reducing the demand for purified beef insulin.

FAQs

What are the main differences between purified beef insulin and human insulin?

Purified beef insulin is more immunogenic compared to human insulin, leading to higher insulin antibody levels. Human insulin, produced through recombinant DNA technology, closely mimics the natural insulin response of the body.

Why has the use of purified beef insulin declined?

The use of purified beef insulin has declined due to the availability of human insulin and insulin analogs, which offer better safety and efficacy profiles.

What are the potential benefits of transgenic cows producing human insulin?

Transgenic cows could provide a more efficient, cost-effective, and scalable method for insulin production, potentially eliminating drug scarcity and high costs for people living with diabetes.

How does the immunogenicity of purified beef insulin impact its use?

The higher immunogenicity of purified beef insulin can lead to reduced long-term efficacy and increased risk of adverse reactions, making it less favorable compared to human insulin.

What is the current market trend for insulin therapy?

The current market trend favors human insulin and insulin analogs due to their superior pharmacokinetic and pharmacodynamic profiles, reducing the demand for purified beef insulin.

Sources

1. Treatment with human insulin (recombinant DNA) in diabetic patients previously treated with beef insulin. PubMed.
2. Immunogenicity of highly purified bovine insulin. PubMed.
3. Evolution of Insulin and How it Informs Therapy and Treatment. Oxford Academic.
4. Milk to the rescue for diabetics? Illinois project creates first insulin-producing cow. ACES Illinois.
5. Illinois project creates first insulin-producing cow. IGB Illinois.