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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR REGULAR INSULIN


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505(b)(2) Clinical Trials for Regular 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Regular 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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Regular Insulin

Condition Name

Condition Name for Regular Insulin
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 Regular Insulin
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 Regular Insulin

Trials by Country

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

Clinical Trial Phase

Clinical Trial Phase for Regular Insulin
Clinical Trial Phase Trials
Phase 4 1309
Phase 3 899
Phase 2/Phase 3 163
[disabled in preview] 957
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Clinical Trial Status

Clinical Trial Status for Regular Insulin
Clinical Trial Phase Trials
Completed 3369
Recruiting 505
Unknown status 436
[disabled in preview] 348
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Clinical Trial Sponsors for Regular Insulin

Sponsor Name

Sponsor Name for Regular Insulin
Sponsor Trials
Novo Nordisk A/S 557
Sanofi 265
Eli Lilly and Company 230
[disabled in preview] 199
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Sponsor Type

Sponsor Type for Regular Insulin
Sponsor Trials
Other 5346
Industry 2503
NIH 645
[disabled in preview] 95
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The Future of Insulin: Clinical Trials, Market Analysis, and Projections

Introduction to Insulin and Its Market

Insulin, a crucial hormone for regulating blood sugar levels, is used to treat all cases of type 1 diabetes and many cases of type 2 diabetes. With approximately 422 million people worldwide affected by diabetes, the demand for insulin and innovative insulin delivery methods is on the rise[2].

Current State of Insulin Delivery

Traditional insulin delivery methods, such as injections via needle and syringe or insulin pumps, have been the standard for decades. However, these methods can be cumbersome and may lead to compliance issues. Recent advancements are focusing on more convenient and effective delivery systems.

Emerging Trends in Insulin Delivery

Oral Insulin

One of the most promising developments is the oral insulin capsule. Endo Axiom, a biotech company, is on the verge of starting phase 1 clinical trials for their oral insulin drug in January 2025. This "smart insulin" has already shown promising results in preclinical trials involving nematodes, mice, and rats, with no instances of low blood sugar events, weight gain, or liver fat accumulation[1].

The oral insulin is formulated into a capsule, previously tested in a practical form as sugar-free chocolate in baboon studies. This innovative approach aims to simplify insulin administration and could significantly reduce the burden on patients. The FDA's regulatory pathway for biological products may expedite the approval process, potentially cutting the typical five- to six-year timeline in half[1].

Inhaled Insulin

Another innovative delivery method is inhaled insulin. MannKind Corporation's Afrezza, an inhaled insulin product, has shown significant advancements. The Phase 4 INHALE-3 study demonstrated that participants using Afrezza achieved better glycemic control compared to standard care, with no increased risk of hypoglycemia[3].

Clinical Trials Update

Oral Insulin Trials

The upcoming phase 1 clinical trials for the oral insulin capsule will be conducted in two parts: phase 1a in healthy individuals and phase 1b in participants with diabetes. The trials will assess the efficacy and safety of the oral insulin, including its ability to clear glucose from the body and its potential to cause hypoglycemia. These trials are crucial for demonstrating biosimilarity to existing insulin products, which is necessary for FDA approval[1].

Other Ongoing Trials

Several other clinical trials are underway, focusing on various aspects of diabetes management. For example, the University of California Health is conducting a study on retatrutide in participants with type 2 diabetes and renal impairment. This study aims to investigate the efficacy and safety of retatrutide compared to placebo in managing glycemic control[4].

Another notable trial is the FABULINUS study, evaluating the safety and efficacy of frexalimab in preserving endogenous insulin secretion in adults and adolescents with newly diagnosed type 1 diabetes. This study involves a 52-week blinded treatment period followed by a 52-week blinded extension[4].

Market Analysis and Projections

Global Insulin Market Size

The global insulin market is experiencing significant growth driven by the increasing prevalence of diabetes, technological advancements in insulin delivery, and rising demand for insulin therapy. As of 2024, the global insulin market size stood at USD 28.64 billion and is anticipated to reach around USD 38.95 billion by 2032[2].

Market Segments

Insulin analogs, which are lab-made versions of insulin, dominated the market in 2023 with a 69.3% share. The Asia Pacific region holds the largest share of the insulin market, accounting for 42.6% in 2023. Rapid-acting insulin is expected to see the fastest growth over the next decade, with a CAGR of 5.5%[2].

Type 1 Diabetes Market

The type 1 diabetes market is also growing, estimated to reach USD 9.4 billion by 2034, with a CAGR of 4.84% during the forecast period. Significant investments in type 1 diabetes research, including immunotherapies and beta cell regeneration, are driving this growth. The National Institutes of Health (NIH) allocated approximately $1.1 billion to diabetes research in 2023, with about 30% specifically for type 1 diabetes[3].

Technological Advancements and Market Drivers

Smart Insulin Pens and Pumps

The rising popularity of smart insulin pens and pumps is a key factor driving the insulin market. These devices offer better glucose monitoring and insulin dosing, enhancing patient compliance and outcomes. Collaborations among key companies to develop insulin analogs and newer injectable formulations are also contributing to market growth[5].

Increasing Prevalence of Diabetes

The global prevalence of diabetes continues to rise, affecting low-income and middle-income countries disproportionately. This increasing prevalence necessitates a growing demand for human insulin, driving market expansion[2].

Challenges and Opportunities

Regulatory Pathways

The regulatory pathway for biological products like insulin can be complex but also offers opportunities for expedited approval. Demonstrating biosimilarity to existing insulin products can significantly reduce the approval timeline, as seen with the oral insulin capsule[1].

Patient Compliance

Improving patient compliance is a significant challenge. Innovative delivery methods like oral and inhaled insulin aim to make insulin administration more convenient, potentially increasing adherence to treatment plans.

Key Takeaways

  • Oral Insulin: Phase 1 clinical trials for oral insulin capsules are set to begin in January 2025, promising a more convenient delivery method.
  • Inhaled Insulin: Afrezza has shown positive results in clinical trials, offering an alternative to traditional injections.
  • Market Growth: The global insulin market is projected to reach USD 38.95 billion by 2032, driven by increasing diabetes prevalence and technological advancements.
  • Type 1 Diabetes: The type 1 diabetes market is expected to reach USD 9.4 billion by 2034, with significant investments in research and development.
  • Technological Advancements: Smart insulin pens, pumps, and new formulations are driving market growth and improving patient outcomes.

FAQs

What is the current status of oral insulin clinical trials?

The phase 1 clinical trials for the oral insulin capsule are expected to start in January 2025, with trials to be conducted in healthy individuals and those with diabetes.

How does the oral insulin capsule differ from traditional insulin delivery methods?

The oral insulin capsule is a more convenient delivery method, eliminating the need for injections. It has been formulated into a capsule and previously tested in a practical form as sugar-free chocolate.

What are the projections for the global insulin market?

The global insulin market is anticipated to reach around USD 38.95 billion by 2032, driven by the increasing prevalence of diabetes and technological advancements.

What role do smart insulin pens and pumps play in the insulin market?

Smart insulin pens and pumps are driving market growth by offering better glucose monitoring and insulin dosing, enhancing patient compliance and outcomes.

How significant is the investment in type 1 diabetes research?

The National Institutes of Health (NIH) allocated approximately $1.1 billion to diabetes research in 2023, with about 30% specifically for type 1 diabetes, highlighting the significant investment in this area.

Sources

  1. Clinical Research News Online: "Latest Oral Insulin Drug Making Its Way To Clinical Trials"
  2. GlobeNewswire: "Global Insulin Market Size to Surpass USD 41.63 Billion by 2033"
  3. BioSpace: "Type 1 Diabetes Market Estimated to Reach USD 9.4 Billion by 2034"
  4. University of California Health: "Diabetes clinical trials at University of California Health"
  5. BioSpace: "Insulin Market Size 2022-2028- Rising Popularity Of Smart Insulin Pens"
Last updated: 2025-01-07

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