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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP BEEF


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505(b)(2) Clinical Trials for Insulin Zinc Susp Beef

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Insulin Zinc Susp Beef

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Zinc Susp Beef

Condition Name

Condition Name for Insulin Zinc Susp Beef
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 Beef
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 Beef

Trials by Country

Trials by Country for Insulin Zinc Susp Beef
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 Beef
Location Trials
California 669
Texas 601
New York 467
Florida 424
Pennsylvania 359
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Clinical Trial Progress for Insulin Zinc Susp Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Beef
Clinical Trial Phase Trials
Phase 4 1309
Phase 3 899
Phase 2/Phase 3 163
[disabled in preview] 957
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Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Beef
Clinical Trial Phase Trials
Completed 3369
Recruiting 505
Unknown status 436
[disabled in preview] 348
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Clinical Trial Sponsors for Insulin Zinc Susp Beef

Sponsor Name

Sponsor Name for Insulin Zinc Susp Beef
Sponsor Trials
Novo Nordisk A/S 557
Sanofi 265
Eli Lilly and Company 230
[disabled in preview] 199
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Sponsor Type

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

Introduction

Insulin Zinc Suspension, a formulation of insulin that includes a zinc salt to modify its action, has been a staple in diabetes management for decades. However, recent changes in regulatory standards and advancements in insulin technology have significant implications for this drug.

Historical Context and Regulatory Changes

Historically, Insulin Zinc Suspension included standards for both bovine and porcine insulin. However, due to the absence of commercial bovine insulin products in the United States, the USP-NF (United States Pharmacopeia-National Formulary) has revised the monographs for Insulin Zinc Suspension and Extended Insulin Zinc Suspension to omit references to bovine insulin and the USP Insulin Beef RS[1][2].

Clinical Trials and Efficacy

Past Studies

Insulin Zinc Suspension has been well-studied in various clinical settings. The efficacy and safety of this formulation have been established through numerous trials, although these trials were often conducted in comparison to other insulin formulations rather than as standalone studies.

Comparison with Modern Insulins

Modern insulin analogs, such as insulin detemir and insulin lispro, have shown improved profiles in terms of glycemic control and reduced hypoglycemia compared to traditional insulins like Insulin Zinc Suspension. For instance, insulin detemir, a long-acting analog, has been shown to have a flatter and more prolonged action profile, although it is less potent than human insulin on a molar basis[4].

Newer Formulations

Newer insulin formulations, such as the ultrarapid insulin lispro (LY900014 or URLi), have been designed to enhance glycemic control with faster absorption and lower hypoglycemia rates. These formulations are likely to capture a significant market share due to their improved pharmacokinetic profiles[3].

Market Analysis

Current Market

The insulin market is highly competitive, with a mix of traditional insulins and newer analogs. Insulin Zinc Suspension, while still used, is facing competition from more advanced formulations that offer better glycemic control and patient convenience.

Market Trends

The trend in the insulin market is towards more advanced and patient-friendly formulations. Rapid-acting and ultra-rapid insulins, as well as combination products that offer both basal and prandial coverage, are gaining traction. Digital health technologies, including smart pens and patch pumps, are also transforming the way insulin is delivered and managed[3].

Pricing and Accessibility

One of the significant challenges for Insulin Zinc Suspension and other insulins is pricing and accessibility. The cost of newer insulin analogs can be prohibitive for many patients, leading to a continued demand for more affordable traditional insulins.

Projections

Market Share

Given the advancements in insulin technology, Insulin Zinc Suspension is likely to see a decline in market share. However, it will still maintain a niche due to its affordability and established use in certain patient populations.

Future Developments

Future developments in insulin therapy are expected to focus on glucose-responsive insulins, bioconjugates, and novel delivery systems. These innovations will further erode the market share of traditional insulins like Insulin Zinc Suspension but may also create opportunities for hybrid or combination products that leverage the strengths of both old and new technologies[3].

Key Components and Quality Control

Zinc Content

Insulin Zinc Suspension contains a zinc salt that affects its pharmacokinetic profile. The zinc content is critical and must be within specified limits (0.12–0.25 mg for every 100 USP Insulin Units) to ensure the product's efficacy and stability[1][2].

Quality Control

Quality control measures for Insulin Zinc Suspension include assays for insulin potency, zinc determination, and analysis of the supernatant for zinc content. These measures ensure that the product meets the required standards for safety and efficacy[1][2].

Patient Adherence and Clinical Outcomes

Adherence

Patient adherence to insulin therapy is a significant factor in clinical outcomes. Newer insulin formulations and delivery systems are designed to improve adherence by offering more convenient and less painful administration methods.

Clinical Outcomes

Clinical outcomes for patients using Insulin Zinc Suspension are generally good, although they may not be as favorable as those seen with newer insulin analogs. The choice of insulin formulation often depends on the patient's specific needs, including the type of diabetes, lifestyle, and personal preferences[3].

Conclusion

Insulin Zinc Suspension remains a viable option for diabetes management, particularly for patients who require a more affordable and established insulin formulation. However, the market is increasingly shifting towards newer, more advanced insulin analogs and innovative delivery systems.

Key Takeaways

  • Regulatory Changes: USP-NF has revised monographs to omit bovine insulin standards.
  • Clinical Trials: Newer insulin analogs show improved glycemic control and reduced hypoglycemia.
  • Market Trends: Shift towards advanced formulations and digital health technologies.
  • Pricing and Accessibility: Affordability remains a significant factor.
  • Future Developments: Focus on glucose-responsive insulins and novel delivery systems.

FAQs

Q: What are the key differences between Insulin Zinc Suspension and newer insulin analogs?

A: Newer insulin analogs offer faster absorption, longer duration of action, and reduced hypoglycemia rates compared to traditional insulins like Insulin Zinc Suspension.

Q: Why has the USP-NF revised the monographs for Insulin Zinc Suspension?

A: The revision was made to omit references to bovine insulin due to the absence of commercial bovine insulin products in the United States.

Q: How does the zinc content affect the pharmacokinetic profile of Insulin Zinc Suspension?

A: The zinc content helps to modify the action of insulin, providing a more prolonged effect.

Q: What are the future prospects for insulin therapy?

A: Future developments will focus on glucose-responsive insulins, bioconjugates, and novel delivery systems to improve glycemic control and patient convenience.

Q: How does patient adherence impact clinical outcomes in insulin therapy?

A: Patient adherence is crucial for optimal clinical outcomes. Newer formulations and delivery systems aim to improve adherence by offering more convenient and less painful administration methods.

Sources

  1. USP-NF: Extended Insulin Zinc Suspension - USP-NF.
  2. USP-NF: Insulin Zinc Suspension - USP-NF.
  3. Xiahe Publishing: Future Prospects of Insulin Mutants, Biosimilars, Bioconjugates, and Newer Insulin-Delivery Devices in Diabetes Mellitus.
  4. EMA: Levemir, INN-insulin detemir.

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