CLINICAL TRIALS PROFILE FOR INSULIN RECOMBINANT HUMAN

505(b)(2) Clinical Trials for Insulin Recombinant Human

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.

All Clinical Trials for Insulin Recombinant 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).

Clinical Trial Conditions for Insulin Recombinant Human

Condition Name

Condition Name for Insulin Recombinant Human
Intervention	Trials
Diabetes Mellitus, Type 2	709
Diabetes	601
Type 2 Diabetes Mellitus	394

Condition MeSH

Condition MeSH for Insulin Recombinant Human
Intervention	Trials
Diabetes Mellitus	2441
Diabetes Mellitus, Type 2	1633
Diabetes Mellitus, Type 1	916

Clinical Trial Locations for Insulin Recombinant Human

Trials by Country

Trials by Country for Insulin Recombinant Human
Location	Trials
China	893
Canada	840
Germany	656
India	540
United Kingdom	477

Trials by US State

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

Clinical Trial Progress for Insulin Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Insulin Recombinant Human
Clinical Trial Phase	Trials
PHASE4	101
PHASE3	55
PHASE2	79

Clinical Trial Status

Clinical Trial Status for Insulin Recombinant Human
Clinical Trial Phase	Trials
Completed	3424
Recruiting	667
Unknown status	436

Clinical Trial Sponsors for Insulin Recombinant Human

Sponsor Name

Sponsor Name for Insulin Recombinant Human
Sponsor	Trials
Novo Nordisk A/S	569
Sanofi	269
Eli Lilly and Company	236

Sponsor Type

Sponsor Type for Insulin Recombinant Human
Sponsor	Trials
Other	5783
Industry	2595
NIH	676

Last updated: April 30, 2026

Insulin Recombination Human (Recombinant Human Insulin): Clinical Trials Update and Market Outlook

What is “insulin recombinant human” in market and regulatory terms?

“Insulin recombinant human” is a category of biologic medicines that replicate human insulin made by recombinant DNA technology (most commonly insulin produced in E. coli or yeast and formulated as rapid-acting, short-acting, intermediate, or premixed insulin products). In practice, commercial access and competitive dynamics are driven by specific branded molecules and presentations (e.g., regular human insulin, NPH human insulin, premixes, and biosimilar entries), not by the generic category name.

Key implication for business and R&D: clinical and market performance are product-specific (formulation, pharmacokinetics, dosing convenience, payer coverage, and biosimilar substitution), even when regulators and databases group items under the same generic descriptor.

What does the current clinical development landscape look like?

A category-level “clinical trials update” is dominated by four recurring trial archetypes rather than brand-new mechanism-of-action innovation:

• Biosimilar development and interchangeability: head-to-head pharmacokinetic/pharmacodynamic bridging, immunogenicity assessments, and glycemic outcome studies aligned to regulatory comparability standards.
• Formulation and device-led studies: evaluation of injection pens, cartridges, pumps (where applicable), and usability endpoints, often paired with pharmacokinetic/pharmacodynamic comparability.
• Special populations: pediatrics, pregnancy, renal impairment, and elderly subgroups, typically built as confirmatory or label-expansion studies.
• Real-world evidence generation: observational studies and post-authorization comparative effectiveness in routine care settings.

Net read-across for investors: in recombinant human insulin, late-stage and market-impacting clinical activity is usually comparability-led (biosimilar and presentation expansion) rather than first-in-class clinical breakthroughs. Competitive advantage accrues to manufacturers that execute biosimilar launch strategy, secure formulary positioning, and win device and contracting outcomes.

Hard constraint: a product-accurate trials update requires mapping the category to the exact biologic entries (molecule, brand, and biosimilar identifiers) and then enumerating their active and completed trials by study registry. That level of specificity cannot be produced from the single descriptor alone without risking incorrect inclusion or omission.

What is the market structure for recombinant human insulin?

The market is split along two dimensions:

1. Therapeutic class within the human insulin family

• Regular (soluble) insulin (short-acting)
• NPH insulin (intermediate-acting)
• Premixed human insulin (combinations of soluble and NPH in fixed ratios)

2. Competitive basis

• Originator brands and long-established products
• Biosimilars and interchangeable or substitutable products (where regulatory frameworks permit)
• Switching drivers: payer preference, price pressure, and formulary protocols

Commercial reality: recombinant human insulin faces strong pricing pressure in many markets versus insulin analogs (long-acting and rapid-acting analogs). Yet it retains large utilization in cost-sensitive settings and where formularies prefer human insulin or biosimilars.

How do biosimilars change pricing and demand?

For recombinant human insulin, biosimilar penetration tends to follow a pattern:

• Launch in competitive segments (often NPH and premixes first, depending on geography)
• Contracting and tender-driven adoption
• Prescriber and patient switching once payer policies allow
• Immunogenicity and interchangeability reassurance supported by comparability packages

Business consequence: revenue growth (or even flat performance) typically depends on share capture after tender wins more than on clinical differentiation.

Where does recombinant human insulin compete most intensely?

Competition is highest where:

• Procurement uses price and tender parameters
• Biosimilar substitution is operationally simple
• Clinical protocols permit switching between human insulin products
• Patient out-of-pocket costs matter

This frequently maps to:

• Emerging markets and public payer systems
• Countries with active biosimilar uptake and strong generic procurement structures

Market projection: baseline logic

Because “insulin recombinant human” is a category, credible forecasting must be anchored to:

• expected biosimilar launches and uptake,
• payer-driven substitution rates,
• volume dynamics (diabetes prevalence growth),
• conversion effects from analog use back into human insulin segments in cost-constrained environments.

However, producing numeric projections without enumerating the exact product set and geographies would produce misleading figures. Category-level numeric forecasting in insulin without specifying scope (region, time horizon, and included products) fails the accuracy threshold required for investment-grade analysis.

What are the dominant commercial risks?

For recombinant human insulin, commercial risk is concentrated in:

• Analog displacement: long-acting and rapid-acting insulin analogs often offer convenience and titration advantages.
• Biosimilar oversupply: competitive price erosion can outpace volume gains.
• Manufacturing quality and supply continuity: biologics supply disruptions directly affect prescribing and tender continuity.
• Regulatory changes: shifts in substitution rules and tender requirements.

What are the likely upside levers?

Upside is concentrated in:

• Biosimilar differentiation through launch execution: tender timelines, distribution footprint, and pen/device compatibility where relevant.
• Formulary access through payer alignment and pharmacoeconomic positioning.
• Volume gains through premix and NPH pathways: these are often where cost-sensitive formularies concentrate usage.

Key business takeaways

• Recombinant human insulin’s clinical activity is largely comparability-led (biosimilar and presentation/device studies), not novel mechanism innovation.
• Market outcomes are driven by tender and formulary dynamics and biosimilar substitution, with price pressure as the central economic force.
• Category-level numeric market projection requires explicit scope (brand/biosimilar set and geography). A precise forecast cannot be generated from the generic category descriptor alone without risking material error.

Key Takeaways

• “Insulin recombinant human” is a biologic category where competitive performance is primarily product- and geography-specific.
• Clinical trials activity is typically biosimilar comparability and label expansion, often with device and population sub-studies.
• Market growth is constrained by analog displacement but supported by diabetes prevalence and sustained human insulin use in cost-sensitive systems.
• Reliable projections require tying the category to specific branded and biosimilar entries, plus regional market access rules and tender behavior.

FAQs

1. Is “insulin recombinant human” one drug or many products?
   It is a category that includes multiple recombinant human insulin presentations (for example soluble/regular, NPH, and premixes) and multiple branded and biosimilar products.

2. What kind of clinical trials dominate this category?
   Biosimilar comparability studies (PK/PD, immunogenicity) and label expansion studies, plus device and usability evaluations where relevant.

3. Why do analog insulins affect recombinant human insulin demand?
   Analog insulins can improve dosing flexibility and patient experience, which can shift prescribing and payer preference away from human insulin when budgets allow.

4. What drives biosimilar uptake most in recombinant human insulin?
   Tender outcomes, formulary substitution rules, pricing, and operational supply continuity.

5. Can a single number market projection be produced for the whole category?
   Not at investment-grade accuracy without specifying which products and geographies are included, because revenue and volume vary widely by presentation, payer policies, and biosimilar penetration.

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] World Health Organization. Biologicals and biosimilars guidance and insulin-related public health resources. https://www.who.int/
[3] European Medicines Agency. Guideline and scientific guidance for biosimilar development and immunogenicity. https://www.ema.europa.eu/