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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF


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All Clinical Trials for Insulin Susp Protamine Zinc Purified Beef

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00348231 ↗ Jikei Optimal Insulin Therapy in Type 2 Diabetes Unknown status Novo Nordisk A/S N/A 2004-11-01 The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.
NCT00348231 ↗ Jikei Optimal Insulin Therapy in Type 2 Diabetes Unknown status Jikei University School of Medicine N/A 2004-11-01 The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.
NCT00474045 ↗ Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes Completed Novo Nordisk A/S Phase 3 2007-05-01 This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).
NCT00487240 ↗ Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes Completed Eli Lilly and Company Phase 3 2007-06-01 The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
NCT00490854 ↗ A Study for Patients With Type 2 Diabetes Mellitus Completed Alkermes, Inc. Phase 2/Phase 3 2007-07-01 The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.
NCT00490854 ↗ A Study for Patients With Type 2 Diabetes Mellitus Completed Eli Lilly and Company Phase 2/Phase 3 2007-07-01 The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.
NCT00494013 ↗ Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) Completed Eli Lilly and Company Phase 3 2007-08-01 The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Susp Protamine Zinc Purified Beef

Condition Name

Condition Name for Insulin Susp Protamine Zinc Purified Beef
Intervention Trials
Diabetes Mellitus, Type 2 16
Diabetes 8
Type 2 Diabetes Mellitus 7
Type 1 Diabetes Mellitus 4
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Condition MeSH

Condition MeSH for Insulin Susp Protamine Zinc Purified Beef
Intervention Trials
Diabetes Mellitus 36
Diabetes Mellitus, Type 2 27
Diabetes Mellitus, Type 1 10
Hyperglycemia 4
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Clinical Trial Locations for Insulin Susp Protamine Zinc Purified Beef

Trials by Country

Trials by Country for Insulin Susp Protamine Zinc Purified Beef
Location Trials
United States 95
South Africa 11
Australia 10
Brazil 9
India 7
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Trials by US State

Trials by US State for Insulin Susp Protamine Zinc Purified Beef
Location Trials
California 7
Texas 7
New York 5
Kentucky 4
Georgia 4
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Clinical Trial Progress for Insulin Susp Protamine Zinc Purified Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Susp Protamine Zinc Purified Beef
Clinical Trial Phase Trials
Phase 4 22
Phase 3 15
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Insulin Susp Protamine Zinc Purified Beef
Clinical Trial Phase Trials
Completed 41
Terminated 4
Recruiting 3
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Clinical Trial Sponsors for Insulin Susp Protamine Zinc Purified Beef

Sponsor Name

Sponsor Name for Insulin Susp Protamine Zinc Purified Beef
Sponsor Trials
Sanofi 9
Eli Lilly and Company 8
Novo Nordisk A/S 7
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Sponsor Type

Sponsor Type for Insulin Susp Protamine Zinc Purified Beef
Sponsor Trials
Other 43
Industry 30
U.S. Fed 1
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Insulin Susp Protamine Zinc Purified Beef: Clinical Trials, Market Analysis, and Projections

Overview of Insulin Susp Protamine Zinc Purified Beef

Insulin Susp Protamine Zinc Purified Beef, also known as Insulin Zinc Suspension or Lentard, is a type of intermediate-acting insulin derived from beef and pork sources. It is designed to help manage blood glucose levels in patients with diabetes mellitus.

Drug Type and Mechanism

This insulin preparation is classified as a hormone and acts as an insulin receptor agonist (INSR agonist), mimicking the natural insulin produced by the body to regulate blood sugar levels[1].

Clinical Trials and Efficacy

Human Clinical Trials

While the specific clinical trials for Insulin Susp Protamine Zinc Purified Beef in humans are not extensively detailed in recent literature, it is important to note that this type of insulin has been largely replaced by more modern, recombinant human insulin preparations. However, historical data and studies on similar protamine zinc insulins provide valuable insights.

Veterinary Clinical Trials

In the veterinary field, particularly for dogs and cats, protamine zinc insulins have shown significant efficacy. For example, a study on recombinant human protamine zinc insulin (rhPZI) in dogs with diabetes mellitus demonstrated that rhPZI effectively decreased blood glucose levels and improved clinical signs such as polyuria and polydipsia[2].

Key Findings

  • Blood Glucose Control: Studies have shown that protamine zinc insulins can significantly reduce mean blood glucose levels and serum fructosamine concentrations, indicating effective glycemic control[2].
  • Clinical Relevance: These insulins are particularly useful in cases where other insulin preparations are ineffective, providing an alternative treatment option for managing diabetes in animals[2].

Market Analysis

Current Market Status

Insulin Susp Protamine Zinc Purified Beef is no longer a dominant player in the human insulin market due to the advent of more advanced and purified insulin preparations. However, it still holds a niche in certain regions or for specific patient populations where access to newer insulins is limited.

Competition

The insulin market is highly competitive, with major players like Novo Nordisk, Sanofi, and Eli Lilly dominating the landscape with their recombinant human insulin and insulin analog products. These newer insulins offer improved profiles in terms of onset and duration of action, reducing the need for older preparations like Insulin Susp Protamine Zinc Purified Beef[5].

Regulatory Status

Insulin Susp Protamine Zinc Purified Beef has been withdrawn from many markets due to the availability of more effective and safer alternatives. The regulatory status varies by country, but it is generally not recommended as a first-line treatment anymore[1].

Market Projections

Declining Demand

Given the advancements in insulin technology and the preference for recombinant human insulins and insulin analogs, the demand for Insulin Susp Protamine Zinc Purified Beef is expected to decline further. This trend is driven by the superior efficacy, safety, and convenience of newer insulin products.

Niche Markets

While the global market for this insulin preparation is shrinking, there may still be niche markets or regions where it remains in use due to cost considerations or limited access to newer insulins.

Veterinary Market

Feline and Canine Use

In the veterinary sector, particularly for felines, protamine zinc insulins like PROZINC (protamine zinc recombinant human insulin) remain a first-line treatment. PROZINC is FDA-approved and AAHA-recommended for managing feline diabetes, highlighting the continued relevance of this type of insulin in veterinary medicine[4].

Safety and Adverse Reactions

Common Adverse Reactions

The use of Insulin Susp Protamine Zinc Purified Beef, like other insulin preparations, is associated with risks such as hypoglycemia, which is the most common adverse reaction. Other potential side effects include local reactions at the injection site and systemic allergic reactions[4].

Precautions

Careful patient monitoring is essential to avoid hypoglycemia and hyperglycemia. The use of glucocorticoids and progestogens should be avoided, and the product should not be used in animals with severe ketoacidosis or other acute conditions without proper stabilization[4].

Conclusion

Insulin Susp Protamine Zinc Purified Beef, although once a staple in diabetes management, has largely been superseded by more advanced and purified insulin preparations. While it may still find use in certain niche markets or veterinary applications, its overall market share and clinical relevance are diminishing.

Key Takeaways

  • Efficacy: Effective in managing blood glucose levels, particularly in veterinary medicine.
  • Market Status: Withdrawn from many markets due to the availability of better alternatives.
  • Regulatory Status: Varies by country but generally not recommended as a first-line treatment.
  • Safety: Associated with hypoglycemia and other adverse reactions.
  • Veterinary Use: Remains relevant for feline diabetes management.

FAQs

What is Insulin Susp Protamine Zinc Purified Beef?

Insulin Susp Protamine Zinc Purified Beef is an intermediate-acting insulin derived from beef and pork sources, used to manage diabetes mellitus.

Why is it no longer widely used in humans?

It has been largely replaced by more modern, recombinant human insulin preparations that offer improved efficacy and safety profiles.

Is it still used in veterinary medicine?

Yes, similar protamine zinc insulins, such as PROZINC, are still used and recommended for managing feline diabetes.

What are the common adverse reactions associated with this insulin?

Hypoglycemia is the most common adverse reaction, along with local reactions at the injection site and systemic allergic reactions.

Why is careful patient monitoring necessary?

To avoid hypoglycemia and hyperglycemia, and to adjust dosages as needed to maintain adequate glycemic control.

Are there any precautions for using this insulin?

Yes, it should not be used in animals with severe ketoacidosis or other acute conditions without proper stabilization, and the use of glucocorticoids and progestogens should be avoided.

Sources

  1. Patsnap Synapse: INSULIN ZINC SUSP PURIFIED BEEF/PORK.
  2. Wiley Online Library: Efficacy of Protamine Zinc Recombinant Human Insulin for Controlling Hyperglycemia in Dogs with Diabetes Mellitus.
  3. Sanofi Press Release: TZIELDĀ® Phase 3 data presented at ISPAD.
  4. Boehringer Ingelheim Animal Health: PROZINCĀ® (protamine zinc recombinant human insulin) for Diabetes.
  5. JAMA Network: Commercial Insulin Preparations.

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