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Last Updated: January 16, 2025

CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP RECOMBINANT HUMAN


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505(b)(2) Clinical Trials for Insulin Zinc Susp 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.
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.
OTC NCT00169299 ↗ Herbal Alternatives for Menopause Symptoms (HALT Study) Unknown status Kaiser Permanente 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Insulin Zinc Susp 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).
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Zinc Susp Recombinant Human

Condition Name

Condition Name for Insulin Zinc Susp Recombinant Human
Intervention Trials
Diabetes Mellitus, Type 2 689
Diabetes 585
Type 2 Diabetes Mellitus 386
Diabetes Mellitus, Type 1 360
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Condition MeSH

Condition MeSH for Insulin Zinc Susp Recombinant Human
Intervention Trials
Diabetes Mellitus 2390
Diabetes Mellitus, Type 2 1540
Diabetes Mellitus, Type 1 861
Insulin Resistance 518
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Clinical Trial Locations for Insulin Zinc Susp Recombinant Human

Trials by Country

Trials by Country for Insulin Zinc Susp Recombinant Human
Location Trials
Canada 811
China 785
Germany 638
India 514
United Kingdom 466
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Trials by US State

Trials by US State for Insulin Zinc Susp Recombinant Human
Location Trials
California 669
Texas 601
New York 467
Florida 424
Pennsylvania 359
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Clinical Trial Progress for Insulin Zinc Susp Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Recombinant Human
Clinical Trial Phase Trials
Phase 4 1309
Phase 3 899
Phase 2/Phase 3 163
[disabled in preview] 1128
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Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Recombinant Human
Clinical Trial Phase Trials
Completed 3369
Recruiting 505
Unknown status 436
[disabled in preview] 650
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Clinical Trial Sponsors for Insulin Zinc Susp Recombinant Human

Sponsor Name

Sponsor Name for Insulin Zinc Susp Recombinant Human
Sponsor Trials
Novo Nordisk A/S 557
Sanofi 265
Eli Lilly and Company 230
[disabled in preview] 292
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Sponsor Type

Sponsor Type for Insulin Zinc Susp Recombinant Human
Sponsor Trials
Other 5346
Industry 2503
NIH 645
[disabled in preview] 95
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Insulin Zinc Susp Recombinant Human: Clinical Trials, Market Analysis, and Projections

Introduction

Insulin Zinc Susp Recombinant Human, commonly known as Protamine Zinc Recombinant Human Insulin (PZI), is a crucial therapeutic agent in the management of diabetes in both humans and animals. This article delves into the clinical trials, market analysis, and future projections of this insulin formulation.

Clinical Efficacy and Trials

Efficacy in Canines

Clinical trials have demonstrated the efficacy of Protamine Zinc Recombinant Human Insulin (PZI) in managing diabetes in dogs. A prospective clinical trial involving 17 diabetic dogs showed that PZI administration resulted in a significant decrease in mean blood glucose levels and serum fructosamine concentrations over a 60-day period. The study found improvements in polyuria, polydipsia, and body weight stability, indicating effective glycemic control[5].

Efficacy in Felines

In felines, PZI, marketed as PROZINC, is the only AAHA-recommended and FDA-approved first-line treatment for feline diabetes. Clinical studies have shown that PROZINC improves glycemic control, reducing symptoms such as excessive thirst and urination in a significant percentage of treated cats. Approximately half of the cats treated with PROZINC showed improvement within 7 days[4].

Safety Profile

While PZI has been shown to be effective, it is not without potential adverse effects. Hypoglycemia is a common adverse event, and some patients may develop hypersensitivity reactions to the protamine or zinc components. However, these risks are generally manageable with proper dosing and monitoring[3][5].

Market Analysis

Global Market Size and Growth

The global Recombinant Human Insulin market, which includes PZI, was valued at approximately USD 32.35 billion in 2022. It is projected to grow to USD 55.99 billion by 2032, at a compound annual growth rate (CAGR) of about 8.5% during the forecast period of 2023-2032. This growth is driven by several factors, including the escalating prevalence of diabetes, technological advancements in insulin delivery systems, and expanding healthcare infrastructure[2].

Regional Market Dynamics

  • North America: This region holds a significant share of the Recombinant Human Insulin market, driven by a high prevalence of diabetes, advanced healthcare infrastructure, and robust research and development activities[2].
  • Europe: The European market benefits from a well-established healthcare system, supportive healthcare policies, and increasing awareness about diabetes management[2].
  • Asia-Pacific: Rapid growth in this region is attributed to the rising incidence of diabetes in countries like China and India, along with increasing healthcare investments and patient awareness[2].

Distribution Channels

The market is segmented by distribution channels, including hospitals, retail pharmacies, online pharmacies, and others. The expansion of online pharmacies and improved access to healthcare services are contributing to the increased adoption of Recombinant Human Insulin[2].

Market Projections

U.S. Market

In the U.S., the human insulin market, which includes PZI, was valued at $7.87 billion in 2022 and is projected to grow to $8.67 billion by 2030. The rise in diabetes prevalence and the introduction of new insulin products with potentially lower costs are key drivers of this growth[3].

Technological Advancements

Technological innovations in insulin delivery systems, formulations, and monitoring technologies are expected to continue driving market growth. These advancements enhance patient convenience and compliance, making insulin therapy more effective and patient-friendly[2].

Personalized Medicine

The shift towards personalized medicine is another significant factor. Recombinant Human Insulin’s ability to be customized to individual patient needs aligns with this trend, contributing to its increasing adoption[2].

Key Factors Influencing Market Growth

Diabetes Prevalence and Awareness

The escalating prevalence of both type 1 and type 2 diabetes is a pivotal growth driver. Rising public awareness about diabetes management and the importance of maintaining glucose levels has spurred the demand for effective insulin therapies[2].

Healthcare Infrastructure Expansion

Improvements in healthcare infrastructure across various regions amplify patient access to insulin therapies. Accessible healthcare facilities, expanded healthcare coverage, and favorable reimbursement policies contribute to the increased adoption of Recombinant Human Insulin[2].

Research and Development

Robust investments in research and development activities drive the discovery of novel insulin formulations, biotechnological enhancements, and delivery systems. This fosters product innovation and differentiation, sustaining market growth[2].

Challenges and Limitations

Adverse Effects and Complications

Modified insulin therapies, including those with protamine and zinc, can develop hypersensitivity and other complications among diabetic patients. These adverse effects may further complicate the condition of diabetic patients, potentially restraining market growth[3].

COVID-19 Pandemic Impact

The COVID-19 pandemic led to a decline in the volume of diabetes testing and decreased sales of insulin products, which temporarily impacted the market. However, as healthcare services normalize, the demand for insulin therapies is expected to rebound[3].

Key Takeaways

  • Clinical Efficacy: Protamine Zinc Recombinant Human Insulin has been proven effective in managing diabetes in both dogs and cats through various clinical trials.
  • Market Growth: The global Recombinant Human Insulin market is projected to grow significantly, driven by the increasing prevalence of diabetes, technological advancements, and expanding healthcare infrastructure.
  • Regional Dynamics: North America, Europe, and the Asia-Pacific region are key markets, each driven by different factors such as prevalence, infrastructure, and awareness.
  • Technological Advancements: Innovations in insulin delivery and monitoring technologies are crucial for market growth.
  • Personalized Medicine: The ability to customize Recombinant Human Insulin to individual patient needs is a significant growth factor.

FAQs

What is Protamine Zinc Recombinant Human Insulin (PZI)?

PZI is a type of insulin formulation that combines recombinant human insulin with protamine and zinc to provide extended duration of action.

What are the clinical benefits of PZI in animals?

PZI has been shown to effectively manage diabetes in dogs and cats, improving glycemic control, reducing symptoms like polyuria and polydipsia, and stabilizing body weight.

What drives the growth of the Recombinant Human Insulin market?

The market growth is driven by factors such as the escalating prevalence of diabetes, technological advancements in insulin delivery systems, expanding healthcare infrastructure, and the growing geriatric population.

How does the COVID-19 pandemic impact the insulin market?

The pandemic led to a temporary decline in diabetes testing and insulin sales but is expected to rebound as healthcare services normalize.

What are the potential adverse effects of PZI?

Potential adverse effects include hypoglycemia and hypersensitivity reactions to the protamine or zinc components.

Sources

  1. PROZINC® (protamine zinc recombinant human insulin) for Diabetes - BI Animal Health.
  2. Global Recombinant Human Insulin Market Size, Trends and Insights - GlobeNewswire.
  3. U.S. Human Insulin Market Growth | Analysis Report [2030] - Fortune Business Insights.
  4. PROZINC® (protamine zinc recombinant human insulin) for Diabetes in Felines - BI Animal Health.
  5. Efficacy of Protamine Zinc Recombinant Human Insulin for Controlling Hyperglycemia in Dogs with Diabetes Mellitus - Wiley Online Library.

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