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Last Updated: March 25, 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.
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.
New Combination NCT00501709 ↗ Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus Completed Juvenile Diabetes Research Foundation Phase 1/Phase 2 2007-02-01 Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
New Combination NCT00501709 ↗ Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus Completed University of California, San Francisco Phase 1/Phase 2 2007-02-01 Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
>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).
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.
NCT00000466 ↗ Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 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.
NCT00000466 ↗ Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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.
>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
[disabled in preview] 949
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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 Market: Clinical Trials, Market Analysis, and Future Projections

Last updated: March 20, 2026

What Is the Current Status of Clinical Trials for Insulin?

As of 2023, multiple clinical trials focus on improving insulin formulations, delivery methods, and patient outcomes. The primary objectives are to enhance insulin stability, reduce hypoglycemia risk, and develop nanotechnology-based delivery systems.

Active Trials Overview

Study Type Number of Trials Focus Area Estimated Completion Year
Phase I 17 Safety and dosing 2024
Phase II 25 Efficacy and optimization 2024-2025
Phase III 7 Confirmatory trials for new formulations 2025-2026

Noteworthy Trials

  • Smart Insulin Delivery Devices: Several studies assess closed-loop insulin pumps incorporating AI for autonomous regulation.
  • Long-Acting Insulins: Trials for biosimilar versions aim to extend dosing intervals to once weekly or bi-weekly.
  • Inhaled Insulin: Phase III trials are evaluating inhaled insulin as a non-invasive alternative with comparable glycemic control.

How Does the Current Market Look?

The global insulin market was valued at approximately USD 18 billion in 2022, with it projected to grow at a CAGR of 7% through 2030 [1].

Key Market Segments

  • By Formulation: Rapid-acting (e.g., insulin lispro), long-acting (e.g., insulin glargine), premixed.
  • By Delivery Method: Injectable pens (majority), inhalers, and upcoming smart devices.
  • By Geography: North America dominates with 45% market share, followed by Europe (25%) and Asia-Pacific (20%).

Major Players and Market Share

Company Market Share (%) Notable Products Focus Areas
Novo Nordisk 43 NovoPen, Tresiba Long-acting insulins, innovation in delivery systems
Eli Lilly 25 Humalog, Basaglar Rapid-acting insulins
Sanofi 15 Lantus, Toujeo Long-acting formulations

Pricing and Reimbursement Landscape

  • Average annual insulin cost per patient ranges between USD 300–USD 800.
  • Reimbursement policies vary globally; US Medicare partially covers insulin, influencing access and utilization.

What Are the Projections for Future Market Growth?

The market anticipates significant growth driven by technological advancements, rising diabetes prevalence, and regulatory approvals advocating easier access.

Growth Drivers

  • Global Diabetes Epidemic: Estimated to reach 700 million diabetics globally by 2045 [2].
  • Innovation in Delivery: FDA approvals pending for smart, connected insulin devices.
  • Biosimilar Expansion: Increased competition is expected to reduce prices, improving affordability.

Forecasted Market Size

  • The global insulin market is expected to reach USD 30 billion by 2030, with a CAGR of around 7% from 2023 to 2030 [1].
  • The smart insulin device segment is projected to grow at a CAGR of over 12%, driven by tech integration and personalized medicine.

Implications for R&D and Investment

  • Companies investing in closed-loop systems, inhaled insulin, and biosimilars will see growth.
  • Clinical success in long-acting, ultra-rapid, or non-invasive insulin formulations could disrupt existing market dynamics.
  • Regulatory pathways for digital insulin delivery systems are evolving, creating new opportunities and challenges.

Key Takeaways

  • Active clinical trials focus on alternative delivery systems, stability, and patient safety.
  • The market remains concentrated with the top three companies holding over 80% share.
  • Growth is driven by rising diabetes prevalence, innovative delivery tech, and biosimilar competition.
  • Market size will likely surpass USD 30 billion by 2030, with a significant segment for connected insulin devices.
  • Investment considerations include emerging technologies and regulatory developments for digital health tools.

FAQs

1. When are new insulin formulations expected to reach the market?
Most are projected for approval between 2024 and 2026, contingent on successful clinical trial outcomes and regulatory review.

2. What is the outlook for generic insulin products?
Biosimilars are entering markets, especially in Europe and Asia, potentially reducing prices and expanding access.

3. How are digital health innovations influencing insulin therapy?
Smart insulin pumps and automated delivery systems are in late-stage trials, promising personalized dosing and better glycemic control.

4. What regions are experiencing the highest growth in insulin adoption?
Asia-Pacific and Latin America are seeing rapid growth due to expanding healthcare infrastructure and rising diabetes incidence.

5. How do regulatory agencies impact market development?
FDA, EMA, and other authorities are increasingly approving innovative delivery systems, influencing R&D priorities and commercial strategies.


References

[1] MarketWatch. (2023). Insulin market size, share, growth, trends, forecast 2023-2030.
[2] International Diabetes Federation. (2022). Diabetes Atlas 10th edition.

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