CLINICAL TRIALS PROFILE FOR INSULIN

505(b)(2) Clinical Trials for Insulin

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.

All Clinical Trials for Insulin

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.

Clinical Trial Conditions for Insulin

Condition Name

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

Clinical Trial Locations for Insulin

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Insulin

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Insulin

Sponsor Name

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

Sponsor Type

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

Oral Insulin: A Revolutionary Leap in Diabetes Treatment

Introduction to Oral Insulin

For over a century, insulin has been the cornerstone of diabetes management, but its administration has been limited to injections. However, with the advent of oral insulin, the landscape of diabetes treatment is on the verge of a significant transformation.

Clinical Trials Update

Human Trials in 2025

Researchers from Endo Axiom Pty Ltd are set to initiate human clinical trials for their oral insulin formulation as early as January 2025. This development follows successful preclinical trials in mice, rats, and baboons, where the oral insulin demonstrated efficacy in reducing blood glucose levels without inducing hypoglycemia[1][4].

Phase 1 Clinical Trials

The phase 1 clinical trial will focus on assessing the safety of the oral insulin and monitoring the incidence of hypoglycemia in both healthy individuals and those with type 1 diabetes. These trials will be conducted under strict quality standards and in collaboration with physicians to ensure the safety of the test subjects. The primary goal is to replicate the positive results seen in baboons, which would be a substantial breakthrough in diabetes treatment[1][4].

Regulatory Pathway

The oral insulin platform is expected to follow the FDA’s regulatory pathway for biological products, which could expedite the approval process. By demonstrating biosimilarity to existing insulin products, the usual five- to six-year timeline for clinical trials could be halved, potentially making the oral insulin available for clinical use within three to four years[4].

Market Analysis

Global Insulin Market

The global insulin market is projected to grow significantly due to the rising prevalence of diabetes. By 2025, the market is forecast to reach $27.81 billion, growing at a CAGR of 5.40% from 2020 to 2025. The primary drivers include the increasing number of diabetic patients and technological advancements in insulin delivery devices[2].

Regional Market Dynamics

North America dominated the human insulin market in 2019, with a share of over 41.2%, followed by the Asia Pacific region. However, the Asia Pacific is expected to grow at a higher CAGR during the forecast period due to rising disposable income, a large diabetic population, and increasing awareness about diabetes-related disorders[2].

U.S. Human Insulin Market

In the U.S., the human insulin market was valued at $7.87 billion in 2022 and is projected to grow to $8.67 billion by 2030. The market is driven by the rise in diabetes prevalence and the introduction of new insulin products with potentially lower costs. Retail and online pharmacies are expected to contribute significantly to the market growth due to their rising sales and availability of cost-effective products[3].

Market Projections

Global Market Growth

The global insulin market is expected to continue its growth trajectory, reaching $23.27 billion by 2033, with a CAGR of 1.3% from 2025 to 2033. This growth is attributed to the increasing prevalence of diabetes and ongoing technological advancements in insulin delivery[5].

Impact of Oral Insulin

The introduction of oral insulin could significantly alter the market dynamics. If successful, oral insulin could offer a more convenient and potentially safer alternative to injectable insulin, which could increase market demand and drive growth. The reduced risk of hypoglycemia and the ease of administration could make oral insulin a preferred choice for many diabetic patients, thereby expanding the market[1][4].

Challenges and Opportunities

Production and Manufacturing Complexities

One of the significant challenges facing the human insulin market is the cost of production and manufacturing complexities. However, advancements in technology and the development of biosimilar insulin products are helping to mitigate these challenges[2].

Rising Adoption of Analog Insulin

The rising adoption of analog insulin among diabetic patients is another factor driving market growth. Analog insulin offers better glycemic control and is expected to continue its dominance in the market[3].

Retail and Online Sales

The increasing sales of insulin products through retail and online pharmacies are expected to boost market growth. These channels offer greater accessibility and affordability, making insulin therapy more accessible to a broader population[3].

Expert Insights

"Trials on humans will start in 2025, led by the spin-out company Endo Axiom Pty Ltd. Our team is very excited to see if we can reproduce the absent hypoglycemia results seen in baboons in humans, as this would be a huge step forward."

— Hunt, cofounder and CEO of Endo Axiom[1].

Statistics and Trends

• 537 million adults worldwide were living with diabetes in 2021, expected to rise to 643 million by 2030[1].
• The global insulin market is forecast to reach $27.81 billion by 2025, growing at a CAGR of 5.40% from 2020 to 2025[2].
• The U.S. human insulin market was valued at $7.87 billion in 2022 and is projected to grow to $8.67 billion by 2030[3].
• 75 million people worldwide inject themselves with insulin daily[4].

Key Takeaways

• Oral insulin is set to enter human clinical trials in 2025, offering a potential breakthrough in diabetes treatment.
• The global insulin market is expected to grow significantly, driven by the rising prevalence of diabetes and technological advancements.
• The U.S. and Asia Pacific regions are key markets, with the latter expected to grow at a higher CAGR.
• Challenges such as production costs and manufacturing complexities are being addressed through technological advancements and the development of biosimilar products.
• The introduction of oral insulin could significantly impact market dynamics, offering a more convenient and safer alternative to injectable 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 January 2025[1][4].

Q: What are the primary goals of the phase 1 clinical trials for oral insulin?

A: The primary goals are to assess the safety of the oral insulin and monitor the incidence of hypoglycemia in both healthy individuals and those with type 1 diabetes[1][4].

Q: How long might it take for oral insulin to be available for clinical use?

A: It could take three to four years for the oral insulin capsule to be in clinical use, depending on the regulatory pathway and trial outcomes[4].

Q: What is driving the growth of the global insulin market?

A: The growth is driven by the rising number of diabetic patients and technological advancements in insulin delivery devices[2].

Q: Which regions are expected to dominate the human insulin market?

A: North America currently dominates the market, but the Asia Pacific region is expected to grow at a higher CAGR during the forecast period[2].

Sources

1. New Atlas: "Oral insulin set for human trials in 2025, may be available in 2-to-3 years."
2. IndustryARC: "Human Insulin Market Size Report, 2020-2025."
3. Fortune Business Insights: "U.S. Human Insulin Market Growth | Analysis Report [2030]."
4. Clinical Research News Online: "Latest Oral Insulin Drug Making Its Way To Clinical Trials."
5. Straits Research: "Insulin Market Size, Share & Growth Analysis Report By 2033."