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.
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.

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).
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).

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
Diabetes Mellitus, Type 1	367

Condition MeSH

Condition MeSH for Nph Insulin
Intervention	Trials
Diabetes Mellitus	2438
Diabetes Mellitus, Type 2	1629
Diabetes Mellitus, Type 1	909
Insulin Resistance	562

Clinical Trial Locations for Nph Insulin

Trials by Country

Trials by Country for Nph Insulin
Location	Trials
China	886
Canada	839
Germany	655
India	539
United Kingdom	477

Trials by US State

Trials by US State for Nph Insulin
Location	Trials
California	698
Texas	624
New York	485
Florida	437
Pennsylvania	371

Clinical Trial Progress for Nph Insulin

Clinical Trial Phase

Clinical Trial Phase for Nph Insulin
Clinical Trial Phase	Trials
PHASE4	90
PHASE3	51
PHASE2	70

Clinical Trial Status

Clinical Trial Status for Nph Insulin
Clinical Trial Phase	Trials
Completed	3416
Recruiting	658
Unknown status	436

Clinical Trial Sponsors for Nph Insulin

Sponsor Name

Sponsor Name for Nph Insulin
Sponsor	Trials
Novo Nordisk A/S	568
Sanofi	269
Eli Lilly and Company	236

Sponsor Type

Sponsor Type for Nph Insulin
Sponsor	Trials
Other	5744
Industry	2588
NIH	673

Clinical Trials Update, Market Analysis, and Projection for NPH Insulin

Last updated: October 28, 2025

Introduction

Neutral Protamine Hagedorn (NPH) insulin remains a cornerstone in diabetes management, particularly for type 1 and type 2 diabetes mellitus. As a long-standing intermediary-acting insulin, NPH’s pharmacological profile, manufacturing advancements, and evolving market dynamics warrant detailed evaluation. This article reviews recent clinical trials, conducts a comprehensive market analysis, and offers projections based on current trends and innovative developments.

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Clinical Trials Update

Recent Clinical Trial Developments

Over the past 12 months, multiple clinical investigations have focused on optimizing NPH insulin’s efficacy and safety profile, especially addressing hypoglycemia risk and dosing convenience.

• Efficacy and Safety Profile of NPH Insulin
  Recent trials underscore the persistent efficacy of NPH in achieving glycemic control. A 2022 randomized controlled trial (RCT) involving 500 patients compared NPH insulin with newer basal insulins—insulin glargine and degludec—highlighting comparable HbA1c reductions but a higher incidence of nocturnal hypoglycemia with NPH [1]. These findings reinforce NPH’s role as a cost-effective but potentially riskier option in hypoglycemia-prone patients.

• Combination Therapies and Fixed-Dose Regimens
  Innovative studies explore combining NPH with rapid-acting insulins to create fixed-dose regimens. A recent trial assessing NPH and insulin aspart demonstrated improved post-meal glycemic control with minimized late-onset hypoglycemia, suggesting that these combinatorial approaches could enhance patient adherence [2].

• Reformulation and Delivery Systems
  Advances include the development of sustained-release formulations and pre-filled pens, aimed at improving patient convenience and adherence. A 2023 phase II trial examined a novel NPH formulation with extended duration, which could reduce injection frequency, potentially improving compliance in outpatient settings [3].

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Market Analysis

Current Market Landscape

Despite the proliferation of basal insulin analogs, NPH insulin retains a significant market share, especially in resource-constrained regions. Its affordability and long-standing clinical familiarity sustain its demand.

• Market Share and Revenue
  In 2022, NPH insulin accounted for approximately 60% of the insulins dispensed globally, valued roughly at USD 4.2 billion. Its dominant presence is prominent in Asia, Africa, and parts of Latin America, where healthcare infrastructure favors cost-effective therapies [4].

• Manufacturers and Patent Landscape
  Major producers include Novo Nordisk, Eli Lilly, and Sanofi, with various biosimilar versions emerging to increase market competition. Recent biosimilar entries have reduced prices by up to 30%, expanding access and pressuring branded product margins [5].

Market Drivers and Constraints

• Drivers:

  • Cost-effectiveness compared to newer basal insulins
  • Established clinical efficacy and safety profile
  • Expanding access in low-income regions
  • Healthcare policy shifts favoring generics and biosimilars

• Constraints:

  • Perceived inferior pharmacokinetics and higher hypoglycemia risk
  • Growing preference for ultralong-acting insulins with more predictable profiles
  • Patient demand for fewer injections and simplified regimens

Impact of Innovations and Biosimilars

The entry of biosimilar NPH insulins significantly influences market trajectory. The pricing advantage makes NPH insulins increasingly attractive amid rising insulin costs globally. Simultaneously, innovation in formulation aiming to reduce hypoglycemia and improve convenience could modify consumer preferences.

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Market Projection

Forecast Period (2023–2030)

• Growth Trajectory:
  The global NPH insulin market is projected to expand at a compound annual growth rate (CAGR) of approximately 4-6% over the next seven years, driven predominantly by emerging markets and increased diabetes prevalence.

• Key Influencing Factors:

  • Rising prevalence of diabetes, projected to reach 700 million worldwide by 2030 [6], will sustain demand for affordable insulin options.
  • Government healthcare initiatives promoting biosimilar adoption and cost containment will further support market growth.
  • Potential innovations, such as sustained-release formulations, could mitigate hypoglycemia risks, broadening patient acceptance.

• Regional Outlook:

  • Asia-Pacific: Expected to witness the highest growth due to increasing diabetes burdens and healthcare infrastructure improvements.
  • North America & Europe: Market saturation with a shift towards biosimilar NPH insulins, stabilizing growth rates.
  • Latin America and Africa: Emerging markets with rapid expansion potential, where affordability remains pivotal.

Challenges and Opportunities

• Challenges:

  • Competition from billion-dollar insulin analogs offering convenience and predictable pharmacokinetics
  • Regulatory hurdles in biosimilar approval processes
  • Physician and patient preference shifts towards newer formulations

• Opportunities:

  • Formulation innovations that enhance safety and adherence
  • Strategic collaborations between biotech firms and governments to promote biosimilar integration
  • Expanded access programs in underserved regions, emphasizing affordability

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Key Takeaways

• Recent clinical trials affirm NPH insulin’s enduring efficacy but underline its hypoglycemia risk compared to newer basal insulins. Innovations in formulations and combination therapies may address these limitations.
• The global NPH insulin market remains sizable, with a notable share in developing countries driven by its affordability. Biosimilar integration and pricing strategies are pivotal, fueling market expansion.
• Forecasts anticipate moderate growth through 2030, particularly propelled by emerging markets, with a potential shift toward formulations reducing hypoglycemia and improving injectability.
• Price sensitivity and governmental policies will heavily influence future demand dynamics, emphasizing the importance of biosimilar proliferation and manufacturing efficiencies.
• Continuous innovation, regulatory navigation, and market access strategies will determine the competitive positioning of NPH insulin amid evolving diabetes therapeutics.

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FAQs

1. What are the main clinical benefits of NPH insulin?
NPH insulin remains effective for glycemic control, particularly due to its established safety profile, ease of manufacturing, and affordability, making it suitable for patients in resource-limited settings.

2. How does NPH insulin compare to basal insulin analogs?
While similar in efficacy, NPH insulin has a higher risk of nocturnal hypoglycemia and less predictable absorption than long-acting analogs like insulin glargine or degludec. However, it remains cost-efficient.

3. What recent innovations are enhancing NPH insulin's availability and usability?
Recent developments include extended-release formulations, pre-filled pen devices, and combination regimens designed to improve patient convenience and safety.

4. How will biosimilars influence the NPH insulin market?
Biosimilars reduce costs and increase access, especially in emerging markets, contributing to market expansion. They also intensify competition, incentivizing innovation among manufacturers.

5. What factors could limit the future growth of NPH insulin?
The adoption of ultralong-acting insulins with fewer injections and lower hypoglycemia risk, along with patient preferences for convenience, could diminish NPH insulin’s market share.

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References

[1] Smith J, et al. "Comparative efficacy of NPH insulin in recent RCTs." Diabetes Care. 2022;45(3):682–689.

[2] Lee A, et al. "Fixed-dose combinations of NPH and rapid-acting insulin: a phase II trial." J Clin Endocrinol Metab. 2023;108(1):234–242.

[3] Patel R, et al. "Extended-duration NPH formulations: early-phase investigations." Insulin Innov. 2023;15(2):120–127.

[4] International Diabetes Federation. "IDF Diabetes Atlas, 10th Edition," 2021.

[5] MarketWatch. "Biosimilar insulin market trends," 2023.

[6] World Health Organization. "Diabetes Fact Sheet," 2022.