Last Updated: May 13, 2026

CLINICAL TRIALS PROFILE FOR INSULIN


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for INSULIN

Condition Name

Condition Name for INSULIN
Intervention Trials
Diabetes Mellitus, Type 2 709
Diabetes 601
Type 2 Diabetes Mellitus 394
Diabetes Mellitus, Type 1 368
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Condition MeSH

Condition MeSH for INSULIN
Intervention Trials
Diabetes Mellitus 2441
Diabetes Mellitus, Type 2 1633
Diabetes Mellitus, Type 1 916
Insulin Resistance 568
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Clinical Trial Locations for INSULIN

Trials by Country

Trials by Country for INSULIN
Location Trials
China 893
Canada 840
Germany 656
India 540
United Kingdom 477
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Trials by US State

Trials by US State for INSULIN
Location Trials
California 699
Texas 625
New York 486
Florida 437
Pennsylvania 371
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Clinical Trial Progress for INSULIN

Clinical Trial Phase

Clinical Trial Phase for INSULIN
Clinical Trial Phase Trials
PHASE4 101
PHASE3 55
PHASE2 79
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Clinical Trial Status

Clinical Trial Status for INSULIN
Clinical Trial Phase Trials
Completed 3424
RECRUITING 667
Unknown status 436
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Clinical Trial Sponsors for INSULIN

Sponsor Name

Sponsor Name for INSULIN
Sponsor Trials
Novo Nordisk A/S 569
Sanofi 269
Eli Lilly and Company 236
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Sponsor Type

Sponsor Type for INSULIN
Sponsor Trials
Other 5783
Industry 2595
NIH 676
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Insulin: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 21, 2026

What are the latest developments in insulin clinical trials?

Recent advances in insulin research focus on improving delivery methods, glycemic control, and onset of action. Key trials include:

  • Ultra-rapid insulins: Multiple Phase 3 studies evaluate formulations like BioChaperone Lispro and Lilly's LY900014, showing faster absorption and reduced post-meal glucose spikes.
  • Delivery devices: Studies assess closed-loop insulin pump systems integrating continuous glucose monitoring (CGM) with automated dosing. Examples include Tandem's Control-IQ and Medtronic's MiniMed 780G, both in advanced stages.
  • Artificial pancreas: Ongoing trials examine closed-loop systems with improved algorithms for better glycemic stability. These systems have gained regulatory approval in several markets.

The timeline for new formulations and device integrations typically spans 3-5 years from trial start to market approval.

How does market share evolve in the insulin segment?

The insulin market remains concentrated among a few key players, with rapid innovation influencing competitive dynamics.

Company Market Share (2022) Key Products R&D Focus
Novo Nordisk 53% NovoLog, NovoRapid, Insulin degludec (Tresiba) Ultra-long-acting insulin, biosimilars
Eli Lilly 19% Humalog, Basaglar, Lilly's rapid-acting formulations Ultra-rapid insulin, biosimilars
Sanofi 15% Lantus, Toujeo, Admelog Long-acting insulin, biosimilars
Others 13% Generics, biosimilar entrants Novel delivery methods, biosimilars

The market's value reached approximately USD 37 billion in 2022 and is projected to grow at a CAGR of 6.8% over 2023-2030.

What are the market projection trends?

Factors driving growth:

  • Rising prevalence of diabetes mellitus, projected to reach 700 million adults worldwide by 2045.
  • Increased adoption of biosimilar and generic insulins, reducing costs.
  • Technological innovations, such as smart insulin patches and closed-loop systems.

Revenue forecasts suggest:

Year Market Size (USD Billion) Compound Annual Growth Rate (CAGR)
2023 39.5
2025 45.3 6.3%
2030 62.8 6.8%

The growth is uneven across regions:

  • North America maintains the highest market share due to advanced healthcare infrastructure.
  • Asia-Pacific shows fastest growth (CAGR 8%) driven by increasing diabetes prevalence and expanding healthcare access.

How do pipeline developments influence future market dynamics?

Pipeline activities involve several innovative approaches:

  • Ultra-rapid acting insulins: Expected to challenge existing rapid-acting formulations due to improved pharmacokinetics.
  • Biosimilar insulins: Aim to reduce prices and expand access, especially in emerging markets.
  • Smart insulin devices: Integrate with digital health platforms, potentially improving adherence and outcomes.

Major companies are investing heavily into these areas, expecting regulatory approvals within 2-4 years, influencing market evolution.

What regulatory trends impact insulin development and commercialization?

Regulators worldwide are accommodating innovation:

  • US FDA prioritizes review of biosimilars and combination products.
  • EMA emphasizes real-world evidence for novel insulins.
  • Emerging markets adopt adapted pathways to expedite approvals for biosimilars.

These regulatory shifts facilitate faster market entry for new formulations and devices, potentially influencing competitive positioning.

Key Takeaways

  • The insulin market is driven by innovation in formulations and delivery devices.
  • Key players hold significant market shares, but biosimilars and advanced systems threaten incumbents.
  • Market size is expected to grow at a CAGR of roughly 6.8% through 2030, with regional disparities.
  • Pipeline products focus on ultra-rapid, biosimilar, and smart insulin technologies.
  • Regulatory bodies are evolving to support quicker adoption of advanced therapies.

Frequently Asked Questions

1. How soon will ultra-rapid insulin formulations be available?
Most are expected to receive regulatory approval within the next 2-3 years, with commercial availability following shortly after.

2. What is the competitive impact of biosimilar insulins?
Biosimilars are likely to reduce pricing and expand access, challenging premium-price market shares of major players.

3. Are any digital health solutions influencing insulin market growth?
Yes. Automated insulin delivery systems and smart devices enhance patient adherence and outcomes, accelerating adoption.

4. How is the COVID-19 pandemic influencing insulin research?
Pandemic disruptions caused delays in some clinical trials but increased investment in digital health and remote monitoring solutions.

5. Will regional regulations significantly alter global insulin market growth?
Yes. Streamlined approval processes in certain regions enable quicker introduction of innovative products, influencing market dynamics.


References

[1] Grand View Research. (2023). Insulin Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). The Global Diabetes Market Snapshot.
[3] U.S. Food and Drug Administration. (2022). Regulatory Pathways for Biosimilar Insulin Products.
[4] European Medicines Agency. (2022). Guidelines on the Evaluation of Insulin Products.
[5] Statista. (2023). Diabetes Mellitus Prevalence Worldwide.

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