CLINICAL TRIALS PROFILE FOR INSULIN

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.

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.

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

Condition MeSH

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

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

Trials by US State

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

Clinical Trial Progress for INSULIN

Clinical Trial Phase

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

Clinical Trial Status

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

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

Sponsor Type

Sponsor Type for INSULIN
Sponsor	Trials
Other	5783
Industry	2595
NIH	676

Last updated: July 22, 2026

Insulin Clinical Trials Update, Market Analysis, and 2030 Projection (2026 Outlook)

Insulin is in active clinical development across multiple modalities: rapid-acting analogs, ultra-rapid formulations, basal analogs, fixed-ratio combinations, and delivery platforms (including smart insulin and automated delivery). Market growth is driven by increasing diabetes prevalence, substitution from human insulin to analogs, and uptake of CGM and automated insulin delivery. Public-company guidance and consensus forecasts point to continued expansion through 2030, with competitive pressure concentrated in rapid-acting and basal analog segments.

What clinical trials are ongoing for insulin in 2026?

Active development spans (1) faster glucose control, (2) reduced hypoglycemia, (3) longer basal coverage, (4) improved user convenience, and (5) platform-scale convenience through injection devices and automated delivery compatibility.

Which insulin clinical trial areas are most visible

Ultra-rapid and faster-onset insulin

• Programs targeting faster absorption and lower early postprandial glucose excursions.
• Delivery approaches include alternative formulations, concentration strategies, and co-formulation methods intended to reduce time-to-action.

Basal insulin with longer duration

• Development focuses on flatter pharmacokinetics to reduce glycemic variability and hypoglycemia risk.
• Strategies include protraction chemistry and molecular engineering for longer residence time.

Smart insulin and automated insulin delivery compatibility

• Trials evaluating insulin dosing kinetics designed for closed-loop or hybrid closed-loop systems.
• Outcomes emphasize time in range (TIR), hypoglycemia incidence, and device integration.

Fixed-ratio combinations and dual action approaches

• Trials assessing cardiovascular and renal outcomes risk signals indirectly via glycemic control endpoints, alongside hypoglycemia and weight outcomes.
• Fixed-dose combinations target adherence improvements and simplified titration.

What trial endpoints dominate insulin studies

• Primary: A1c change from baseline, proportion achieving A1c targets, or mean glucose reduction.
• Time in range (TIR 70–180 mg/dL) for CGM-enabled trials.
• Hypoglycemia metrics: rates of Level 2 and Level 3 hypoglycemia; nocturnal hypoglycemia incidence.
• Safety: injection-site reactions, antibody immunogenicity, weight change, and device-related adverse events (where relevant).

How big is the insulin market, and what segments are growing fastest?

Insulin remains the largest prescription segment within diabetes therapeutics by patients treated, and it is expanding through (1) prevalence growth and (2) analog replacement in type 1 and type 2 diabetes.

Key market drivers

• Diabetes incidence and prevalence growth.
• Increasing clinician and payer preference for insulin analogs over human insulin due to dosing convenience and hypoglycemia profile.
• Uptake of CGM and insulin pumps, raising demand for delivery-compatible insulin kinetics.
• Continued shift toward basal-bolus intensification and fixed-ratio regimen adoption.

Segment growth priorities

Rapid-acting analogs

• Highest replacement and adherence impact tied to mealtime dosing accuracy.
• Competitive intensity around onset speed and postprandial control.

Basal insulin

• Growth tied to once-daily regimens and broader type 2 initiation and intensification pathways.
• Product differentiation increasingly tied to hypoglycemia risk and glycemic variability.

Concentrated formulations

• Upside in settings where injection volume reduction improves adherence and dosing accuracy.
• Particularly relevant in insulin-resistant patients.

Which insulin products are most competitively positioned for 2026–2030?

Competition centers on analog lineups, new-generation protracted insulins, ultra-rapid candidates, and combination products. Pricing and access constraints differ by geography, affecting uptake trajectories.

Commercial positioning by insulin class

Rapid-acting

• Leadership depends on TIR improvements, reduced hypoglycemia risk, and device/CGM compatibility.
• Differentiation is increasingly incremental rather than step-change, raising the value of real-world outcomes and formulary access.

Basal

• Differentiation increasingly rests on hypoglycemia reduction and stable overnight control.
• Contracting and payer placement drive realized demand.

Combination and fixed-ratio

• Targets adherence and simplified titration.
• Expansion depends on patient segmentation and titration guidance.

When does insulin lose exclusivity, and what launch timing risks exist for generics?

Exclusivity timelines in insulin are fragmented by product, jurisdiction, and patent family. For U.S. branded products, patent expiration and any regulatory exclusivities determine Paragraph IV viability and non-infringing design-around strategies.

What typically governs generic entry timing

• Composition-of-matter patent expirations.
• Formulation and method-of-use patents.
• Delivery device or manufacturing process patents (where applicable).
• FDA regulatory exclusivities (where triggered) and any pediatric exclusivity extensions.

Generic entry risk map (how to think about it)

• Rapid-acting products face denser patent coverage because formulation and onset kinetics can be claim-relevant.
• Basal products can have prolonged device and formulation patent thickets.
• Concentrated formulations can carry separate patent estates tied to concentration and dose-volume relationships.

What patents protect insulin formulations and delivery performance?

Insulin patent estates generally split into:

• Molecular composition and engineered analogs
• Manufacturing methods and process controls
• Formulation (stabilizers, pH, solubilizers, aggregation control)
• Concentration and presentation formats
• Method-of-use (titration regimens, hypoglycemia risk reduction claims)
• Delivery devices (where claims are directed)

Common claim themes seen in insulin patenting

• Protraction strategies and residency time.
• Aggregation suppression and shelf-life stabilization.
• Manufacturing steps controlling immunogenicity-relevant attributes.
• Dosing regimens tied to glycemic outcomes.

What is the Orange Book status of insulin products in the U.S.?

Orange Book status is driven by FDA-approved branded insulin NDA/BLA products and any listed patents by the sponsor. Orange Book coverage typically includes formulation, method-of-use, and device-related claims where the sponsor has listed them.

How to use Orange Book status for market timing

• Patents listed in the Orange Book for a given NDA/BLA indicate likely blocking for generic filers.
• Patent-by-patent expiry determines when Paragraph IV challenges become legally viable and when generic launches become practical.

Which companies are challenging insulin patents with Paragraph IV?

Insulin generic and biosimilar competition is usually preceded by:

• Paragraph IV filings for small-molecule analogs in insulin-like products where applicable.
• Interpreting FDA patent lists, then designing around formulation or method-of-use claims.

For biosimilar insulin, the “challenge” concept shifts to biosimilar pathway and interchangeability and involves different exclusivity and litigation dynamics.

How does insulin compare with GLP-1 and other diabetes drugs on clinical outcomes and market share?

Insulin’s market position is driven by hard clinical necessity for many patients, while GLP-1 receptor agonists and dual agonists have captured share for earlier-line management in type 2 diabetes. The competitive dynamic is less substitution in insulin-dependent disease and more sequencing.

Key comparative reality

• Insulin is required for type 1 diabetes and often for advanced type 2.
• Modern insulin development competes against improved diabetes management strategies by reducing hypoglycemia and burden, not by eliminating insulin need entirely.

What biosimilar insulin risks exist for incumbents?

Biosimilar insulin launch risk depends on:

• Biosimilar regulatory approval status and interchangeability designation (jurisdiction-specific).
• Patent estate coverage, especially formulation, stability, and manufacturing comparability.
• Payer policies and contracting speed.

Where biosimilar uptake typically accelerates

• When patent barriers narrow.
• When payer formularies normalize biosimilar use.
• When interchangeability status or strong evidence in real-world use supports switching.

What insulin patent litigation affects market entry most?

Insulin litigation impacts generic and biosimilar timelines through:

• Preliminary injunction dynamics
• Settlement agreements that define effective launch dates
• Appeals that extend uncertainty windows

Settlement-driven launch patterns

• Settlements often set carve-outs by product, strength, or indication.
• Effective entry timing can diverge from nominal patent expiry through agreed design-arounds.

How strong is the patent estate for insulin versus alternatives?

Patent strength in insulin is typically high due to:

• Dense families covering composition, formulation, manufacturing, and methods of use.
• Platform-specific families for protraction and ultra-rapid mechanisms.

Strength is highest where claim scope covers kinetic behavior and formulation-defined properties, which are harder to replicate without infringement.

What formulations are protected by insulin patent families?

Formulation protection tends to focus on:

• Stabilizers and buffering systems
• Aggregation control and particle-size distribution targets
• Presentation stability and shelf-life attributes
• Concentration-specific formulation claims

Manufacturing method patents: what barriers can block insulin generics/biosimilars?

Manufacturing patents can block entry even if a generic candidate uses a different formulation route, because:

• Process controls can be claimable.
• Purification steps can be essential elements of asserted claims.
• Batch consistency parameters can map to claimed methods.

Commercial projection: where will insulin demand concentrate through 2030?

Demand is expected to concentrate in:

• Rapid-acting insulin substitution within type 2 intensification.
• Basal analog growth in broader type 2 initiation and titration pathways.
• Continued adoption of CGM and automated delivery raising demand for insulin with compatible kinetics.

2030 projection logic for insulin

Growth rate depends on:

• Prevalence growth and insulin initiation rates
• Ongoing analog substitution rate
• Payer and government tender dynamics
• Biosimilar and generic penetration where patent barriers narrow

2030 outlook by geography: how policy and pricing drive insulin sales?

• U.S.: market growth shaped by biosimilar/generic competition, payer formulary constraints, and negotiated rebates. Litigation and exclusivity windows determine near-term entry.
• Europe: tendering and centralized procurement often compress pricing and accelerate biosimilar uptake.
• Emerging markets: adoption depends on affordability, supply stability, local distribution capacity, and reimbursement access.

Key Takeaways

• Insulin development remains active across ultra-rapid, longer-acting basal, fixed-ratio combinations, and delivery-platform compatibility.
• Market growth is driven by diabetes prevalence, analog substitution, and rising CGM/automated delivery usage.
• Exclusivity and patent estates govern launch timing for generics and biosimilars; dense formulation and method-of-use coverage increases design-around complexity.
• Competitive intensity remains highest in rapid-acting and basal segments, with biosimilar uptake tied to patent and contracting speed.

FAQs

1. Which insulin candidates have the fastest time-to-action targets in phase 2 or phase 3?
2. How do CGM endpoints like time in range change insulin trial design versus A1c-only studies?
3. What patent categories most often block insulin biosimilar launch schedules?
4. How do payer rebate and tender systems differ between U.S. and Europe for insulin access?
5. What are the main real-world adoption barriers to switching patients from an originator insulin to a biosimilar?

References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Guidance for Industry: Biosimilars. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. Insulin trials database. National Library of Medicine.