CLINICAL TRIALS PROFILE FOR NPH INSULIN

505(b)(2) Clinical Trials for Nph 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.

All Clinical Trials for Nph 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).

Clinical Trial Conditions for Nph Insulin

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Nph Insulin

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Nph Insulin

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Nph Insulin

Sponsor Name

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

Sponsor Type

Sponsor Type for Nph Insulin
Sponsor	Trials
Other	5783
Industry	2595
NIH	676

Last updated: April 28, 2026

NPH Insulin: Clinical-Stage Update, Market Snapshot, and 2026-2035 Projection

What is NPH insulin and where does it sit in the development pipeline?

NPH insulin (Neutral Protamine Hagedorn) is a long-acting, human insulin formulation. It is approved and marketed as a legacy basal insulin across major markets. The commercial landscape today is shaped less by NPH’s own “clinical development” and more by:

• Line extensions (patient-device formats, concentrates, biosimilar competition in regions where applicable, and labeling updates)
• Switching dynamics as prescribers and payers move toward glargine, detemir, degludec, and faster-acting analogs, as well as GLP-1/dual-agonist combinations

Pipeline implication: New “registration trials” for NPH are generally not driving today’s competitive advantage. The key clinical signal stream is comparative effectiveness and safety evidence versus insulin analogs, plus substitution outcomes seen in real-world studies.

What clinical data is driving usage decisions versus insulin analogs?

Across comparative clinical evidence, NPH tends to face consistent constraints relative to insulin analog basal products:

• Higher hypoglycemia risk profile (especially nocturnal hypoglycemia in some settings)
• More variable pharmacokinetics requiring strict titration and routine glucose monitoring
• More complex regimens in practice, with dosing that is often more sensitive to meal patterns and adherence

Insulin analogs are repeatedly selected on convenience and pharmacodynamic stability. That said, NPH retains structural advantages that matter for payer and patient economics:

• Lower acquisition cost in most markets
• Broad availability and established clinical familiarity
• Formulary fit when cost constraints dominate and patient monitoring support exists

Clinical trial update framing for NPH: There is no sustained global pattern of NPH entering late-stage registrational trials comparable to modern insulin analog development. The operational “trial” for NPH is the ongoing shift in prescribing standards, payer policies, and guideline-recommended basal options.

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How big is the NPH insulin market and what determines growth or decline?

What is the market structure for basal insulin?

Basal insulin demand is driven by:

• Diabetes prevalence and insulin initiation rates
• Type 1 vs Type 2 mix
• Therapy intensity (basal-only vs basal-bolus vs basal plus incretin-based therapies)
• Payer formulary design
• Switching and persistence after adverse events or inadequate glycemic control

NPH’s market trajectory is tied to how strongly payer systems prioritize insulin analogs versus generics and legacy human insulins.

What are the main demand headwinds for NPH?

1. Formulary substitution: Insulin analogs often displace NPH after guideline uptake and procurement contracts.
2. Adherence and titration burden: NPH requires management to mitigate variability.
3. Patient and clinician preference: Analog basal stability reduces routine monitoring friction in real-world workflows.

What are NPH’s main growth tailwinds?

1. Cost sensitivity in government programs and high-insurance-erosion markets
2. Access expansion where biosimilar/analog penetration is limited
3. Form factor and availability for low-resource settings
4. Medical need where analog access is constrained

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Market Analysis: 2026-2035 Projection Framework

How should NPH insulin demand be projected?

A credible projection uses three levers:

• Volume: linked to insulin-treated diabetes population growth and insulin intensification patterns
• Share: NPH share vs analogs and biosimilar analogs
• Price: net price after payer contracting and program rebates

Given NPH is a mature product with competitive displacement by analog basal insulins, the baseline expectation is:

• Modest absolute volume growth or decline depending on geography
• Declining share in most commercial markets
• More durable share in cost-constrained systems

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2026-2035 Baseline Projection (Global): Where NPH is headed

Directionally, the global NPH insulin market is projected to:

• Grow slowly in value in the early years where unit volumes remain stable and net pricing holds
• Face share erosion from insulin analogs and newer combination regimens in countries with strong procurement power and high analog adoption
• Maintain resilience in lower-cost settings and public formularies

Baseline projection (market direction only):

• Value: low single-digit CAGR early, turning flat to mid-single-digit negative later depending on pricing pressure and substitution intensity
• Volume: low single-digit growth or slight decline, concentrated where analog access lags

Scenario sensitivities:

• Price compression from generic competition and payer renegotiations accelerates value decline.
• Analog biosimilar uptake reduces NPH share more quickly.
• Access programs and tender structure can stabilize NPH volumes.

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Key Competitive Dynamics

Who competes with NPH insulin in the basal category?

NPH’s competition is primarily:

• Insulin glargine (including biosimilar equivalents)
• Insulin detemir
• Insulin degludec
• Combination strategies where basal is paired with GLP-1 receptor agonists or dual incretin therapies (reducing total insulin intensity in some patients)

The competitive pattern is substitution at initiation and switching with inadequate control on NPH.

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Clinical and Regulatory Considerations That Affect Adoption

What operational factors decide whether NPH persists in formularies?

• Titration support infrastructure (clinic protocols, patient education, monitoring access)
• Hypoglycemia risk management workflows
• Reimbursement design and step-therapy rules
• Availability of analog alternatives through procurement and insurance contracts

Where systems can support intensive titration and monitoring, NPH sustains use longer.

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Business Implications for R&D and Investment

What does NPH’s market trajectory imply for development strategy?

For companies evaluating adjacent opportunities, NPH’s dynamics imply:

• The defensible space is not “new NPH molecules” but delivery systems, combination regimens, and differentiated basal performance
• If targeting cost-sensitive markets, the winning strategy is access economics and reliability, not marginal pharmacodynamic improvements

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Key Takeaways

• NPH insulin is a mature, approved basal insulin with limited ongoing registrational-stage innovation relative to insulin analogs.
• Clinical decision-making increasingly favors analog basal insulins due to pharmacokinetic stability and hypoglycemia risk profiles, which drives formulary displacement.
• NPH market value is pressured by share loss and net price erosion in commercial markets, but volume durability is plausible in cost-constrained geographies.
• 2026-2035 outlook is low-growth to declining value globally, with higher resilience where cost and access constraints dominate.
• The competitive center of gravity is basal analog substitution and integration into combination therapy ecosystems.

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FAQs

1. Is NPH insulin still widely used?
   Yes. It remains used globally, especially where cost and access constraints limit analog adoption.

2. Why do insulin analogs displace NPH?
   Analog basal insulins have more predictable pharmacodynamics and are associated with improved convenience and, in many comparisons, a hypoglycemia advantage.

3. Does NPH have any growth opportunities?
   Growth is most likely in lower-cost markets, public programs, and settings with strong titration and monitoring support.

4. What most affects NPH’s pricing and revenue trajectory?
   Payer formulary decisions, contracting terms, and substitution pressure from biosimilar and originator analog basals.

5. What clinical endpoints matter most for NPH’s competitive position?
   Hypoglycemia rates, glycemic control consistency, titration burden, and real-world persistence on therapy.

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Sources (APA)

[1] World Health Organization. (2016). Global report on diabetes. https://www.who.int/
[2] American Diabetes Association. (2024). Standards of Care in Diabetes. Diabetes Care. https://diabetesjournals.org/
[3] International Diabetes Federation. (2021). IDF Diabetes Atlas. https://diabetesatlas.org/
[4] FDA. (n.d.). Insulin approvals and labeling resources. https://www.fda.gov/
[5] EMA. (n.d.). Medicinal product information and insulin-related regulatory resources. https://www.ema.europa.eu/