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	689
Diabetes	585
Type 2 Diabetes Mellitus	386
Diabetes Mellitus, Type 1	360

Condition MeSH

Condition MeSH for Nph Insulin
Intervention	Trials
Diabetes Mellitus	2390
Diabetes Mellitus, Type 2	1540
Diabetes Mellitus, Type 1	861
Insulin Resistance	518

Clinical Trial Locations for Nph Insulin

Trials by Country

Trials by Country for Nph Insulin
Location	Trials
Canada	811
China	785
Germany	638
India	514
United Kingdom	466

Trials by US State

Trials by US State for Nph Insulin
Location	Trials
California	669
Texas	601
New York	467
Florida	424
Pennsylvania	359

Clinical Trial Progress for Nph Insulin

Clinical Trial Phase

Clinical Trial Phase for Nph Insulin
Clinical Trial Phase	Trials
Phase 4	1309
Phase 3	899
Phase 2/Phase 3	163

Clinical Trial Status

Clinical Trial Status for Nph Insulin
Clinical Trial Phase	Trials
Completed	3369
Recruiting	505
Unknown status	436

Clinical Trial Sponsors for Nph Insulin

Sponsor Name

Sponsor Name for Nph Insulin
Sponsor	Trials
Novo Nordisk A/S	557
Sanofi	265
Eli Lilly and Company	230

Sponsor Type

Sponsor Type for Nph Insulin
Sponsor	Trials
Other	5346
Industry	2503
NIH	645

NPH Insulin: Clinical Trials, Market Analysis, and Projections

Introduction to NPH Insulin

NPH (Neutral Protamine Hagedorn) insulin is a type of intermediate-acting insulin that has been a cornerstone in the management of diabetes for decades. It is used to control blood sugar levels in patients with type 1 and type 2 diabetes.

Clinical Trials and Efficacy

Comparative Studies with Other Insulins

Several clinical trials have compared the efficacy and safety of NPH insulin with other types of insulin.

• A 26-week randomized trial compared the addition of NPH insulin to oral therapy versus insulin detemir in patients with type 2 diabetes. The study found that while both insulins reduced HbA1c levels similarly, insulin detemir had a lower risk of hypoglycemia (47% reduction for all hypoglycemia and 55% reduction for nocturnal hypoglycemia) and less weight gain compared to NPH insulin[1].

• Another study compared the addition of glargine (a long-acting insulin) to NPH insulin in patients with inadequate glycemic control on oral therapy. This 24-week trial showed that both glargine and NPH insulin reduced HbA1c levels to similar extents, but glargine had a slightly better profile in terms of fasting plasma glucose and nocturnal hypoglycemia[4].

Titration and Dosage

Clinical trials often involve titration protocols to optimize insulin dosages. For example, in the treat-to-target trial comparing glargine and NPH insulin, the dosage was titrated weekly based on fasting plasma glucose measurements to achieve a target of ≤100 mg/dl (5.5 mmol/l)[4].

Patient Outcomes

Studies have consistently shown that NPH insulin, when used appropriately, can effectively reduce HbA1c levels and improve glycemic control. However, it may have a higher risk of hypoglycemia compared to some newer insulin analogues like insulin detemir or glargine[1][4].

Market Analysis

Market Size and Growth

The insulin market, which includes NPH insulin, is expected to grow significantly over the next few years.

• The global insulin market is projected to reach USD 33.81 billion by 2029, growing at a CAGR of 3.87% from 2024 to 2029[5].
• The short-acting and intermediate-acting insulin segment, which includes NPH insulin, is part of this larger market. The short-acting insulin market alone is expected to reach USD 7.48 billion by 2025 and grow to USD 8.87 billion by 2030 at a CAGR of 3.46%[2].

Key Players

Major pharmaceutical companies dominate the insulin market, including:

• Novo Nordisk A/S
• Eli Lilly and Company
• Sanofi
• Pfizer Inc.
• Biocon[2][5].

These companies are continuously developing new insulin products and formulations, which may impact the market share of traditional insulins like NPH.

Regional Market

North America holds the largest share of the global insulin market, driven by the high prevalence of diabetes and the presence of major pharmaceutical companies in the region. However, the Asia Pacific region is expected to grow at the highest CAGR over the forecast period[5].

Market Projections

Future Trends

The insulin market is evolving with the introduction of new insulin analogues and combination products.

• Ultra-rapid-acting and liver-targeted insulin analogues, as well as insulin-plus-GLP-1 combinations, are in late-stage development. These products promise tighter glucose control, greater convenience, and reduced risk of hypoglycemia[3].
• Long-acting insulins, which can last up to 42 hours, are expected to drive patient compliance and market growth. New biosimilar long-acting insulins, such as Novo Nordisk’s unbranded biologic insulin Degludec, are gaining FDA approvals and contributing to market expansion[5].

Challenges and Opportunities

Despite the advancements in insulin therapy, traditional insulins like NPH insulin still have a place in the market due to their established efficacy and lower cost.

• However, the increasing competition from newer insulin analogues and combination products may reduce the market share of NPH insulin.
• Opportunities exist for NPH insulin in regions where access to newer insulins is limited due to cost or availability constraints.

Patient Compliance and Adherence

Patient compliance is a critical factor in the success of any insulin therapy. NPH insulin, being an intermediate-acting insulin, requires careful timing and dosing to avoid hypoglycemia and maintain glycemic control.

• Studies have shown that long-acting insulins, which reduce the frequency of injections, can improve patient compliance. However, NPH insulin remains a viable option for patients who prefer or require an intermediate-acting insulin[5].

Conclusion

NPH insulin remains an important part of diabetes management, despite the emergence of newer insulin analogues. Clinical trials have established its efficacy, although it may have a higher risk of hypoglycemia compared to some newer insulins. The market for NPH insulin is part of the larger and growing insulin market, driven by the increasing prevalence of diabetes globally.

Key Takeaways

• Efficacy: NPH insulin is effective in reducing HbA1c levels but may have a higher risk of hypoglycemia compared to some newer insulins.
• Market Size: The global insulin market, including NPH insulin, is projected to grow significantly over the next few years.
• Regional Market: North America holds the largest share, but the Asia Pacific region is expected to grow at the highest CAGR.
• Future Trends: Newer insulin analogues and combination products are expected to drive market growth and patient compliance.
• Patient Compliance: NPH insulin requires careful dosing and timing to maintain glycemic control and avoid hypoglycemia.

FAQs

1. What is the current market size of the insulin market that includes NPH insulin? The global insulin market is estimated at USD 27.96 billion in 2024[5].

2. How does NPH insulin compare to newer insulin analogues in terms of hypoglycemia risk? NPH insulin has a higher risk of hypoglycemia compared to some newer insulin analogues like insulin detemir and glargine[1][4].

3. Which region is expected to grow the fastest in the insulin market? The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period[5].

4. What are the key factors driving the growth of the insulin market? The rising prevalence of diabetes, the increasing number of novel insulin product launches, and growing government initiatives to create awareness about diabetes are key factors driving the market growth[5].

5. Who are the major players in the insulin market? Major players include Novo Nordisk A/S, Eli Lilly and Company, Sanofi, Pfizer Inc., and Biocon[2][5].

Sources

1. Hermansen, K., et al. "A 26-Week, Randomized, Parallel, Treat-to-Target Trial Comparing Insulin Detemir with NPH Insulin as Add-on Therapy to Oral Glucose-Lowering Drugs in People with Type 2 Diabetes." Diabetes Care, vol. 29, no. 6, 2006, pp. 1269-1274.
2. Mordor Intelligence. "Short-acting Insulin Market - Share, Size & Industry Analysis."
3. Drug Development. "The Market for Type 2 Diabetes Therapeutics - Key Findings From a Recent Analysis of Global Drug Development Efforts."
4. Riddle, M. C., et al. "The Treat-to-Target Trial: Randomized Addition of Glargine or Human NPH Insulin to Oral Therapy of Type 2 Diabetic Patients." Diabetes Care, vol. 26, no. 11, 2003, pp. 3080-3086.
5. Mordor Intelligence. "Insulin Market - Size, Share, Growth & Trends."