CLINICAL TRIALS PROFILE FOR INSULIN HUMAN

Biosimilar Clinical Trials for insulin human

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02631928 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 1	2016-02-01	This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
NCT02631928 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III	Completed	Julphar Gulf Pharmaceutical Industries	Phase 1	2016-02-01	This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
NCT02634515 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal	Completed	Parexel	Phase 1	2014-12-01	This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.
NCT02634515 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 1	2014-12-01	This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.
NCT02634515 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal	Completed	Julphar Gulf Pharmaceutical Industries	Phase 1	2014-12-01	This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.

All Clinical Trials for insulin human

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

Clinical Trial Conditions for insulin human

Condition Name

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

Clinical Trial Locations for insulin human

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for insulin human

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for insulin human

Sponsor Name

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

Sponsor Type

Sponsor Type for insulin human
Sponsor	Trials
Other	5346
Industry	2503
NIH	645

Oral Insulin: A Revolutionary Step in Diabetes Management

Introduction to Oral Insulin

Diabetes, a condition affecting over 537 million adults worldwide as of 2021, is a significant global health challenge. Traditional insulin administration via injections or insulin pumps has been the standard treatment, but it comes with its own set of challenges, including the risk of hypoglycemia and the inconvenience of frequent injections. However, a groundbreaking development in oral insulin is set to change the landscape of diabetes management.

Clinical Trials Update

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

Phase I Trials

The initial phase of these clinical trials will focus on the safety of the oral insulin and the incidence of hypoglycemia in both healthy individuals and those with type 1 diabetes. The trials will adhere to strict quality requirements and will be conducted in collaboration with physicians to ensure the safety of the test subjects[1][4].

Phase II and Beyond

Following the successful completion of phase I, the trials will proceed to phase II, where the efficacy of the oral insulin in replacing injections for diabetic patients will be evaluated. The researchers are optimistic about reproducing the positive results seen in baboons, where the oral insulin lowered blood sugar levels without causing hypoglycemia[1][4].

Market Analysis

The human insulin market is experiencing robust growth driven by several key factors.

Market Size and Growth

The global human insulin market is projected to reach $27.81 billion by 2025, growing at a CAGR of 5.40% during the forecast period 2020-2025. Another report suggests the market will grow at a CAGR of 8.1%, highlighting the increasing demand for human insulin analogs and technological advancements in delivery devices[2][3].

Drivers of Market Growth

• Rising Prevalence of Diabetes: The increasing number of diabetic patients worldwide is a primary driver. By 2030, the number of adults with diabetes is expected to rise to 643 million[1][2].
• Technological Advancements: Innovations in insulin delivery devices, such as pens, pen needles, and continuous glucose monitoring systems, are enhancing treatment options and patient adherence[2][5].
• Increasing Disposable Income and Awareness: Rising disposable income and growing awareness about diabetes-related disorders are also contributing to the market growth[2].

Regional Market Dynamics

North America dominated the human insulin market in 2019, but the Asia Pacific region is expected to grow at a higher CAGR due to the rising prevalence of diabetes and increasing awareness about the condition[2].

Market Projections

Future Market Size

The global insulin market is estimated to reach USD 23.21 billion by 2030, growing at a CAGR of 3.74% from 2025 to 2030. This growth is driven by the increasing prevalence of diabetes, particularly type 2, and advancements in formulations such as rapid-acting and long-acting insulins[5].

Product Segments

The long-acting insulin segment is expected to continue its dominance due to its longer duration of effect and the reduced number of injections required. Human insulin drugs and biologics, including biosimilars, are also expected to see significant growth[3][5].

Key Players

Major players in the insulin market include Novo Nordisk A/S, Eli Lilly and Company, Sanofi, Biocon Ltd, and others. These companies are driving innovation and expanding market reach through various product offerings and technological advancements[5].

Challenges and Opportunities

Challenges

Despite the promising outlook, the human insulin market faces several challenges:

• Cost of Production: High manufacturing costs pose a significant barrier to market growth[2][3].
• Regulatory Requirements: Stringent regulatory requirements for product approval can slow down the introduction of new products[3].

Opportunities

The development of oral insulin presents a significant opportunity to revolutionize diabetes management. If successful, it could offer a more convenient, precise, and potentially safer alternative to traditional insulin administration methods.

"This way of taking insulin is more precise because it delivers the insulin rapidly to the areas of the body that need it most," said Peter McCourt, one of the study’s co-authors. "When you take insulin with a syringe, it is spread throughout the body where it can cause unwanted side effects."[1]

Impact on Diabetes Management

The potential impact of oral insulin on diabetes management is substantial. Here are a few key points:

Convenience and Compliance

Oral insulin could significantly improve patient compliance by eliminating the need for frequent injections, making it easier for patients to manage their condition[1][4].

Reduced Hypoglycemia Risk

The new oral insulin has shown promising results in reducing the risk of hypoglycemia in animal models, which could be a major breakthrough for diabetic patients[1][4].

Quality of Life

By offering a more convenient and potentially safer method of insulin administration, oral insulin could significantly improve the quality of life for diabetic patients.

Key Takeaways

• Clinical Trials: Human clinical trials for oral insulin are set to begin in 2025, focusing on safety and efficacy.
• Market Growth: The global human insulin market is projected to grow significantly, driven by the rising prevalence of diabetes and technological advancements.
• Market Size: The market is expected to reach $27.81 billion by 2025 and $23.21 billion by 2030.
• Challenges: High production costs and stringent regulatory requirements are key challenges.
• Opportunities: Oral insulin presents a revolutionary opportunity to improve diabetes management.

FAQs

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

A: Human clinical trials for oral insulin are expected to start in 2025, led by the spin-out company Endo Axiom Pty Ltd[1][4].

Q: What are the primary drivers of the human insulin market growth?

A: The rising prevalence of diabetes, technological advancements in insulin delivery devices, and increasing awareness about diabetes-related disorders are primary drivers[2][3].

Q: Which region is expected to grow at a higher CAGR in the human insulin market?

A: The Asia Pacific region is expected to grow at a higher CAGR due to the rising prevalence of diabetes and increasing awareness[2].

Q: What are the potential benefits of oral insulin for diabetic patients?

A: Oral insulin could offer improved convenience, reduced risk of hypoglycemia, and a better quality of life for diabetic patients[1][4].

Q: Who are the major players in the human insulin market?

A: Major players include Novo Nordisk A/S, Eli Lilly and Company, Sanofi, Biocon Ltd, and others[5].

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. MarketsandMarkets: Human Insulin Market Revenue Forecast | Latest Industry Updates.
4. ScienceDaily: New medicine can create a new life for diabetes patients -- without injections.
5. Grand View Research: Insulin Market Size, Share & Growth | Industry Report, 2030.