CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP PROMPT BEEF

All Clinical Trials for Insulin Zinc Susp Prompt Beef

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00467246 ↗	Sub-Cutaneous Insulin in Hyperglycaemic Emergencies	Withdrawn	The Royal Bournemouth Hospital	N/A	1969-12-31	Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.
NCT00657280 ↗	Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure	Completed	Merck Sharp & Dohme Corp.	Early Phase 1	2008-04-01	This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
NCT00657280 ↗	Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure	Completed	Stanford University	Early Phase 1	2008-04-01	This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.

Clinical Trial Conditions for Insulin Zinc Susp Prompt Beef

Condition Name

Condition Name for Insulin Zinc Susp Prompt Beef
Intervention	Trials
Insulin Resistance	2
Congenital Hyperinsulinism	1
Diabetes Mellitus	1

Condition MeSH

Condition MeSH for Insulin Zinc Susp Prompt Beef
Intervention	Trials
Diabetes Mellitus	2
Insulin Resistance	2
Diabetes Mellitus, Type 2	1

Clinical Trial Locations for Insulin Zinc Susp Prompt Beef

Trials by Country

Trials by Country for Insulin Zinc Susp Prompt Beef
Location	Trials
United States	4
United Kingdom	1
Israel	1
Italy	1

Trials by US State

Trials by US State for Insulin Zinc Susp Prompt Beef
Location	Trials
New York	1
California	1
North Carolina	1
District of Columbia	1

Clinical Trial Progress for Insulin Zinc Susp Prompt Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Prompt Beef
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Prompt Beef
Clinical Trial Phase	Trials
Completed	5
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for Insulin Zinc Susp Prompt Beef

Sponsor Name

Sponsor Name for Insulin Zinc Susp Prompt Beef
Sponsor	Trials
The Royal Bournemouth Hospital	1
AstraZeneca	1
Merck Sharp & Dohme Corp.	1

Sponsor Type

Sponsor Type for Insulin Zinc Susp Prompt Beef
Sponsor	Trials
Other	11
Industry	3
NIH	1

Insulin Zinc Suspension Prompt Beef: Clinical, Market, and Projection Analysis

Introduction

Insulin Zinc Suspension Prompt Beef, a formulation of insulin that was once widely used, has undergone significant changes and faced discontinuation in several regions. Here, we will delve into the clinical aspects, market analysis, and projections for this drug.

Clinical Overview

Definition and Composition

Insulin Zinc Suspension Prompt Beef is a sterile suspension of insulin in buffered Water for Injection, modified by the addition of a suitable zinc salt. This formulation was designed to provide a prompt action, similar to regular insulin, but with the stability and prolonged action afforded by the zinc suspension[1].

Clinical Use and Efficacy

Historically, this insulin was used to manage diabetes mellitus, particularly in patients requiring a rapid onset of action. However, with advancements in insulin technology and the development of more purified and humanized insulins, its use has declined. The insulin was highly effective in controlling blood glucose levels, but it had limitations such as variability in absorption and action duration compared to modern insulins[5].

Discontinuation and Regulatory Changes

Discontinuation in the US and Canada

Insulin Zinc Suspension Prompt Beef has been discontinued in the US and Canada since 2017. This decision was largely driven by the unavailability of suitable bovine insulin reference materials and the absence of approved manufacturers of therapeutic bovine insulin in these regions[2][4].

Regulatory Revisions

The United States Pharmacopeia (USP) has revised the monographs for insulin products, including Insulin Zinc Suspension, to remove requirements associated with bovine insulin. This revision was necessary due to the well-resolved peaks of bovine and porcine insulin in assays, making the USP Insulin Beef Reference Standard unnecessary for identification of porcine insulin[1][4].

Market Analysis

Current Market Status

The market for Insulin Zinc Suspension Prompt Beef has significantly diminished following its discontinuation. Modern insulin formulations, such as human insulin analogs and biosimilars, have become the preferred choices due to their improved purity, consistency, and patient outcomes.

Competitive Landscape

The insulin market is now dominated by highly purified human insulin and insulin analogs produced by major pharmaceutical companies. These newer insulins offer better glycemic control, reduced immunogenicity, and more predictable pharmacokinetics compared to older bovine or porcine insulins[5].

Projections and Future Outlook

Declining Demand

Given the discontinuation and regulatory changes, the demand for Insulin Zinc Suspension Prompt Beef is expected to continue declining. Patients and healthcare providers are increasingly opting for more advanced and reliable insulin formulations.

Emerging Alternatives

The future of insulin therapy lies in advanced formulations such as ultra-long-acting insulins, inhaled insulins, and insulin pumps with continuous glucose monitoring systems. These technologies are expected to further reduce the need for traditional insulin suspensions like Insulin Zinc Suspension Prompt Beef.

Clinical Trials and Research

There are no ongoing clinical trials specifically focused on Insulin Zinc Suspension Prompt Beef due to its discontinuation. Current research in the field of diabetes management is centered around improving the efficacy, safety, and convenience of newer insulin formulations and delivery systems.

Key Takeaways

• Discontinuation: Insulin Zinc Suspension Prompt Beef has been discontinued in the US and Canada since 2017.
• Regulatory Changes: USP has revised monographs to remove requirements associated with bovine insulin.
• Market Decline: The market for this insulin has significantly diminished in favor of modern, highly purified insulins.
• Future Outlook: The demand is expected to continue declining as newer, more advanced insulin formulations become prevalent.

FAQs

What is Insulin Zinc Suspension Prompt Beef?

Insulin Zinc Suspension Prompt Beef is a sterile suspension of insulin in buffered Water for Injection, modified by the addition of a suitable zinc salt, derived from bovine sources.

Why was Insulin Zinc Suspension Prompt Beef discontinued?

It was discontinued in the US and Canada due to the unavailability of suitable bovine insulin reference materials and the absence of approved manufacturers of therapeutic bovine insulin.

What are the current alternatives to Insulin Zinc Suspension Prompt Beef?

Current alternatives include highly purified human insulin and insulin analogs, which offer better glycemic control and more predictable pharmacokinetics.

Are there any ongoing clinical trials for Insulin Zinc Suspension Prompt Beef?

No, there are no ongoing clinical trials specifically focused on this insulin due to its discontinuation.

What is the future outlook for Insulin Zinc Suspension Prompt Beef?

The demand is expected to continue declining as patients and healthcare providers opt for more advanced and reliable insulin formulations.

Sources

1. USP-NF: Prompt Insulin Zinc Suspension - USP-NF.
2. DrugBank: Insulin zinc suspension prompt beef | DrugBank Online.
3. FDA: 2024 Student Scientific Research Day 08302024 - FDA (not directly related but provides context on vaccine and immune response studies).
4. USP-NF: Notice of Intent to Revise - Insulin, Insulin Injection, Insulin Zinc Suspension.
5. JAMA Network: Commercial Insulin Preparations - JAMA Network.