CLINICAL TRIALS PROFILE FOR INSULIN HUMAN

Biosimilar Clinical Trials for insulin human

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02631928 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 1	2016-02-01	This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
NCT02631928 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III	Completed	Julphar Gulf Pharmaceutical Industries	Phase 1	2016-02-01	This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
NCT02634515 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal	Completed	Parexel	Phase 1	2014-12-01	This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.
NCT02634515 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 1	2014-12-01	This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.
NCT02634515 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal	Completed	Julphar Gulf Pharmaceutical Industries	Phase 1	2014-12-01	This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.

All Clinical Trials for insulin human

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.

Clinical Trial Conditions for insulin human

Condition Name

Condition Name for insulin human
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 human
Intervention	Trials
Diabetes Mellitus	2441
Diabetes Mellitus, Type 2	1633
Diabetes Mellitus, Type 1	916
Insulin Resistance	568

Clinical Trial Locations for insulin human

Trials by Country

Trials by Country for insulin human
Location	Trials
China	893
Canada	840
Germany	656
India	540
United Kingdom	477

Trials by US State

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

Clinical Trial Progress for insulin human

Clinical Trial Phase

Clinical Trial Phase for insulin human
Clinical Trial Phase	Trials
PHASE4	101
PHASE3	55
PHASE2	79

Clinical Trial Status

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

Clinical Trial Sponsors for insulin human

Sponsor Name

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

Sponsor Type

Sponsor Type for insulin human
Sponsor	Trials
Other	5783
Industry	2595
NIH	676

Insulin Human (Human Insulin): Clinical Trial Update, Market Analysis, and 10-Year Projection

Last updated: April 28, 2026

What is “Insulin Human” in the drug landscape?

“Human insulin” is recombinant insulin formulated to match the amino-acid sequence of endogenous human insulin. In practice, the market is dominated by products derived from recombinant DNA and sold under multiple brands and authorized generics by different manufacturers. Commercial formulations typically include:

• Short-acting regular insulin (insulin human, regular)
• Intermediate-acting NPH insulin (insulin human isophane)
• Fixed combinations (where regular and NPH are co-formulated by specific brands)

Because “Insulin Human” is a class-wide description rather than a single marketing authorization, clinical and market metrics aggregate across multiple MAHs (marketing authorization holders) and products.

Clinical trials update: what is actively progressing?

A complete, current “clinical trials update” for all human insulin products requires a product-level mapping (brand, formulation, sponsor, NCT record). That mapping is not provided in the request, and “Insulin Human” alone does not define a unique clinical-trial universe. With insufficient specificity, a complete and accurate trial update cannot be produced.

Market analysis: where does human insulin sit today?

Human insulin is a mature, high-volume insulin category. In most markets, it faces structural share pressure from modern insulins:

• Rapid-acting insulin analogs (higher use in basal-bolus and intensification)
• GLP-1 and dual agonists (for glycemic control strategies that reduce insulin initiation and titration needs)

That said, human insulin remains entrenched due to:

• Cost sensitivity in many markets and payer systems
• Formulary entrenchment and established clinician familiarity
• Use in resource-limited settings where insulin analog access is constrained

Demand drivers

Key demand drivers for human insulin include:

• Diabetes prevalence growth and aging populations
• Insulin initiation and switching driven by price and reimbursement
• Formulary inclusion for basal and prandial strategies where analogs are not first line

Supply and pricing dynamics

Human insulin supply is characterized by:

• Multiple parallel manufacturers
• Generic and biosimilar-style competition in many regions for recombinant proteins (regulatory pathways vary by jurisdiction)
• Price competition in tender-driven healthcare systems

Competitive positioning

Human insulin is primarily competitive on:

• Unit price
• Availability and procurement reliability
• Predictable pharmacodynamics of regular and NPH profiles

It typically underperforms analogs on:

• Postprandial glucose control
• Hypoglycemia risk profile
• Dosing flexibility (particularly for regular insulin)

Market projection: 10-year outlook

A credible 10-year projection requires a defined starting point (current global market size, category segmentation, geography splits, and forecast basis). Those numeric anchors are not provided, and the category is too broad to calculate a precise, defensible model without product-level scope.

A precise projection cannot be generated from “Insulin Human” alone because:

• market value depends on regular vs NPH vs combinations
• share depends on regional reimbursement and tender cycles
• growth rate depends on analog displacement rate and out-of-pocket affordability
• patent and exclusivity dynamics differ by individual marketing authorizations

Actionable implications for investors and R&D

Even without a quantified forecast, the strategic direction for human insulin remains clear:

• Focus on cost and supply resilience: human insulin competes primarily on price and procurement stability.
• Portfolio protection via formulation + distribution: differentiators that analogs do not allow (for example, tender-based contracts, contracting networks) matter.
• Development strategy: most “value-add” in mature insulin classes comes from lifecycle improvements (device compatibility, stability, packaging, traceability, and patient-use workflows) rather than novel insulin pharmacology.

Regulatory and patent context (high level)

Human insulin is a longstanding biological product class. Most value in the category is not driven by long-running patent exclusivity but by:

• Manufacturing know-how
• Regulatory dossiers and interchangeability/authorization status
• Distribution and contracting
• Lifecycle claims tied to specific formulations, devices, and manufacturing processes

Key Takeaways

• “Insulin Human” describes a mature class (regular insulin and NPH-like intermediate formulations) sold across multiple brands and authorized manufacturers; the category is too broad for a precise, product-level clinical trials update without explicit product scope.
• Human insulin demand remains supported by affordability and formulary inclusion, but share faces continued displacement from modern insulin analog strategies and insulin-sparing regimens.
• A defensible 10-year numeric market projection requires a defined current market baseline and segmentation (regular vs NPH vs combinations; geography; payer environment). Without these anchors, a complete and accurate projection cannot be produced.

FAQs

1) Is “Insulin Human” one drug or a class?
It is a class-level label that covers human insulin formulations such as regular insulin and NPH/isophane insulin, marketed under multiple products.

2) Why does human insulin persist despite insulin analogs?
Price, tender-driven procurement, formulary position, and accessibility in constrained healthcare budgets.

3) What would improve market share for human insulin?
Lower acquisition cost, stable supply, favorable contracting, and patient-use improvements aligned to existing clinical workflows.

4) How do clinical trial trends typically look for mature insulin classes?
Trials more often support bioequivalence, formulation or device integration, and real-world usability rather than new mechanisms.

5) What inputs are essential for a numeric market forecast?
Category segmentation, geography split, current market size, and forecast assumptions tied to analog displacement and payer reimbursement.

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References

[1] No sources were provided or cited in the request.