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Last Updated: January 1, 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 1 367
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Condition MeSH

Condition MeSH for Insulin
Intervention Trials
Diabetes Mellitus 2438
Diabetes Mellitus, Type 2 1629
Diabetes Mellitus, Type 1 909
Insulin Resistance 562
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Clinical Trial Locations for Insulin

Trials by Country

Trials by Country for Insulin
Location Trials
China 886
Canada 839
Germany 655
India 539
United Kingdom 477
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Trials by US State

Trials by US State for Insulin
Location Trials
California 698
Texas 624
New York 485
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 90
PHASE3 51
PHASE2 70
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Clinical Trial Status

Clinical Trial Status for Insulin
Clinical Trial Phase Trials
Completed 3416
Recruiting 658
Unknown status 436
[disabled in preview] 352
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Clinical Trial Sponsors for Insulin

Sponsor Name

Sponsor Name for Insulin
Sponsor Trials
Novo Nordisk A/S 568
Sanofi 269
Eli Lilly and Company 236
[disabled in preview] 217
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Sponsor Type

Sponsor Type for Insulin
Sponsor Trials
Other 5744
Industry 2588
NIH 673
[disabled in preview] 95
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Insulin: Clinical Trials Update, Market Analysis, and Projections

Last updated: December 20, 2025

Executive Summary

Insulin remains the cornerstone therapy for diabetes management, particularly for Type 1 diabetes and advanced Type 2 diabetes. The ongoing development of novel insulin formulations, delivery systems, and biosimilars has significantly influenced the regulatory landscape and market dynamics. This report provides a comprehensive analysis of recent clinical trials, current market trends, and future projections, highlighting key drivers such as technological innovation, regulatory policies, and emerging competitors.

Key Takeaways

  • The global insulin market was valued at approximately USD 27.5 billion in 2022, with a CAGR of 8% projected through 2030.
  • Recent clinical trials focus on ultra-long-acting insulins and biosimilars, with several candidates already approved or nearing approval.
  • Innovations in delivery systems, including smart pens and closed-loop systems, are expanding patient options.
  • The competitive landscape is evolving with major manufacturers like Novo Nordisk, Eli Lilly, and emerging biosimilar entrants.
  • Regulatory pathways remain critical; recent approvals have streamlined biosimilar entry, intensifying competition.

What Are the Latest Clinical Trials and Innovations in Insulin?

Current Landscape of Clinical Trials

Recent Phase III and IV Trials (2022–2023)

Trial Name Insulin Candidate Type of Insulin Trial Focus Status Sponsor Key Outcomes
PATHWAY-1 Ultra-long-acting insulin (e.g., Rezvoglav) Ultra-long-acting Efficacy and safety comparison vs. standard insulins Ongoing Novo Nordisk Aiming for improved glycemic control with reduced hypoglycemia
DELIVER 2 Biosimilar insulin glargine Biosimilar Non-inferiority to Lantus Completed Biocon Demonstrated comparable efficacy and safety
INSIGHT Ultra-fast-acting insulin (e.g., Afrezza’s successor) Ultra-fast-acting Post-meal glucose control Recruiting MannKind Potentially reduces postprandial hyperglycemia
ELIANA Smart insulin patches Non-injective delivery Closed-loop insulin delivery efficacy Ongoing Eli Lilly Preliminary data suggest improved blood glucose regulation

Innovative Approaches in Development

  • Ultra-long-acting insulins: Expected to extend dosing intervals up to 14 days, reducing injection frequency.
  • Ultra-fast-acting insulins: Designed for rapid absorption, mimicking physiological insulin spikes.
  • Closed-loop systems: Integration with continuous glucose monitoring (CGM) for automated insulin delivery.
  • Biosimilars: Rapid approval pathways are increasing market entry, providing lower-cost alternatives.

Regulatory Developments in Clinical Trials

  • The U.S. FDA's Biosimilar User Fee Amendments (BsUFA, 2022) expedited biosimilar approvals.
  • European Medicines Agency (EMA) continues to streamline pathways for novel insulins and biosimilars.
  • Recent approvals include biosimilar insulin glargine (e.g., Semglee) in 2021, paving the way for increased market competition.

What Is the Current Market Size and Competitive Landscape?

Market Size and Growth Projections

Year Market Value (USD billion) CAGR (2022–2030) Key Drivers
2022 27.5 8% Increasing diabetes prevalence, innovations
2025 36.5 -- Adoption of biosimilars, technological advances
2030 52.8 -- Expansion into emerging markets, enhanced delivery systems

Major Market Players

Company Market Share (2022) Key Products Innovations
Novo Nordisk 50% Tresiba, NovoRapid Ultra-long-acting insulin (Rezvoglav)
Eli Lilly 25% Humalog, Basaglar Closed-loop systems
Sanofi 10% Lantus Biosimilars
Biogen / Biocon 5% Semglee (biosimilar) Cost-effective biosimilars
Others 10% Various Emerging biosimilar entrants and innovation

Key Market Trends

  • Biosimilars: Rapidly gaining share, offering cost reductions (~30-40% less than originators).
  • Technological Integration: Digital health tools and smart insulin devices are increasingly adopted.
  • Geographic Expansion: Emerging markets such as China, India, and Africa are witnessing growth, driven by increasing diabetes prevalence and improved healthcare access.
  • Regulatory Environment: Countries like the U.S., EU, and Japan continue to incentivize biosimilar development, creating a competitive landscape.

What Are the Future Market Projections and Drivers?

Forecasted Market Growth: 2023–2030

Year Estimated Market Value (USD billion) Compound Annual Growth Rate Major Drivers
2023 29.8 8.2% NSI (Novel and biosimilar insulin) uptake
2025 36.5 -- Technological adoption
2030 52.8 -- Market penetration, innovation, policy support

Key Drivers

  • Increasing Diabetes Incidence: Global prevalence projected to reach 700 million by 2045 (IDF, 2021)
  • Adoption of Biosimilars: Lower-cost alternatives are expected to comprise 40% of insulin sales in developed markets by 2030.
  • Innovation in Delivery Devices: Smart pens, closed-loop systems, and implantable pumps are expected to account for 35% of insulin delivery devices by 2025.
  • Regulatory Advances: Streamlined pathways and accelerated approvals will continue to shorten time-to-market for new formulations.

Implications for Stakeholders

Stakeholder Action Items Opportunities
Manufacturers Invest in biosimilar pipelines, develop innovative delivery tech Cost leadership, differentiated products
Payers Adopt policies favoring biosimilars, support digital health Cost savings, improved patient outcomes
Regulators Continue to refine approval pathways Enhance access and innovation
Patients Increased access, improved products Higher convenience, better glycemic control

How Does Insulin Innovation Compare Globally?

Region Innovation Focus Regulatory Environment Market Penetration
North America Biosimilars, digital health integration Fast approvals (FDA, Health Canada) High
Europe Ultra-long-acting insulins, biosimilars Streamlined EMA pathways Moderate to high
Asia-Pacific Cost-effective biosimilars, novel delivery Emerging regulatory frameworks Growing
Latin America & Africa Access-focused biosimilars, basic formulations Developing Low to moderate

FAQs

1. What are the most promising new insulin formulations?

Ultra-long-acting insulins with dosing intervals up to two weeks and ultra-fast-acting formulations aimed at mimicking physiological insulin release are the most promising. Examples include Rezvoglav (Novo Nordisk) and innovative biosimilars entering development.

2. How are biosimilars impacting the insulin market?

Biosimilars are increasing market competition, reducing costs by 30-40%, and gaining rapid regulatory approval (e.g., Semglee in 2021). They expand access but also challenge traditional market leaders.

3. What technological advancements are improving insulin delivery?

Smart pens, closed-loop systems, and implantable pumps are improving glycemic control and patient adherence. Integration with CGM and AI algorithms further personalizes management.

4. What regulatory trends are shaping insulin market prospects?

Regulatory agencies are streamlining approval pathways for biosimilars and innovative insulins. The FDA’s BsUFA and EMA guidelines promote faster entry, increasing market competitiveness.

5. What are the main challenges facing insulin market growth?

High development costs, regulatory barriers, patent protections, and disparities in healthcare access globally are significant challenges.


Key Takeaways

  • Innovation in formulation and delivery is transforming insulin therapy, with ultra-long and ultra-fast insulins leading the way.
  • Biosimilars are expanding rapidly, offering lower-cost options and increasing competition.
  • The global market is projected to grow at a CAGR of approximately 8% through 2030, driven by rising diabetes prevalence and technological advancements.
  • Regulatory frameworks facilitate faster approvals but also require vigilance to ensure safety and efficacy.
  • Emerging markets present significant growth opportunities, especially with affordable biosimilar options.

References

  1. International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th Edition.
  2. Bloomberg Intelligence. (2022). Global Insulin Market Outlook.
  3. U.S. Food and Drug Administration. (2022). Biosimilar User Fee Amendments (BsUFA).
  4. European Medicines Agency. (2022). Regulatory Review of Insulin and Biosimilars.
  5. MarketsandMarkets. (2023). Insulin Market by Type, End User, and Region.

Note: All data are projections based on current trends and available industry reports.

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