CLINICAL TRIALS PROFILE FOR INSULIN SUSP ISOPHANE BEEF

All Clinical Trials for Insulin Susp Isophane Beef

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00658099 ↗	Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®	Completed	Novo Nordisk A/S		2007-11-01	This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
NCT00665808 ↗	Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany	Completed	Novo Nordisk A/S		2007-10-01	This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
NCT01122979 ↗	Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.	Completed	Sanofi	Phase 4	2010-07-01	Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: - Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. - Incidence of confirmed symptomatic and nocturnal hypoglycemia. - Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. - Creatinine clearance at baseline and after each period of treatment. - Overall safety: Incidence of adverse events.
NCT01680185 ↗	Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation	Completed	Medical University of Vienna	Phase 3	2012-08-01	The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment with short acting insulin, applied continuously through an insulin pump, (i) improves glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection, in comparison to the standard of care control group, and the basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic events. Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.

Clinical Trial Conditions for Insulin Susp Isophane Beef

Condition Name

Condition Name for Insulin Susp Isophane Beef
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	3
Hyperglycemia	2
Diabetes	2

Condition MeSH

Condition MeSH for Insulin Susp Isophane Beef
Intervention	Trials
Diabetes Mellitus	7
Diabetes Mellitus, Type 2	4
Hyperglycemia	2
Diabetes Mellitus, Type 1	1

Clinical Trial Locations for Insulin Susp Isophane Beef

Trials by Country

Trials by Country for Insulin Susp Isophane Beef
Location	Trials
United States	16
Germany	4
Canada	4
Burkina Faso	2
Brazil	1

Trials by US State

Trials by US State for Insulin Susp Isophane Beef
Location	Trials
Virginia	1
Washington	1
Tennessee	1
South Carolina	1
Pennsylvania	1

Clinical Trial Progress for Insulin Susp Isophane Beef

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Insulin Susp Isophane Beef
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for Insulin Susp Isophane Beef

Sponsor Name

Sponsor Name for Insulin Susp Isophane Beef
Sponsor	Trials
Profil Institut für Stoffwechselforschung GmbH	2
Julphar Gulf Pharmaceutical Industries	2
Novo Nordisk A/S	2

Sponsor Type

Sponsor Type for Insulin Susp Isophane Beef
Sponsor	Trials
Other	11
Industry	8

Insulin Susp Isophane Beef: Clinical Trials, Market Analysis, and Projections

Introduction

Insulin Susp Isophane Beef, a type of intermediate-acting insulin, has been a cornerstone in the management of diabetes mellitus for decades. However, its use has evolved significantly due to advancements in insulin technology, changes in regulatory standards, and the emergence of newer insulin formulations. Here, we will delve into the current state of clinical trials, market analysis, and future projections for Insulin Susp Isophane Beef.

Historical Context and Development

Insulin Susp Isophane Beef, also known as NPH (Neutral Protamine Hagedorn) insulin, was developed to provide a longer duration of action compared to regular insulin. It is a suspension of zinc-insulin crystals and protamine sulfate, which slows down the absorption of insulin, allowing for intermediate-acting effects[4].

Clinical Trials and Safety Concerns

Allergic Reactions and Sensitivity

Clinical observations have highlighted the potential for allergic reactions to Insulin Susp Isophane Beef, particularly when switching between different types of insulin. A case study reported a patient who developed chronic urticaria after changing from isophane beef insulin to isophane beef-pork insulin, indicating sensitivity to the bovine and porcine components[1].

Transitioning to Alternative Insulins

Clinical trials and guidelines emphasize the importance of careful monitoring when transitioning patients from standard beef or mixed species insulins to purified pork or human insulins. Dosage adjustments may be necessary, and any change in treatment should be closely monitored to avoid hypoglycemia or hyperglycemia[4].

Regulatory Changes and Market Impact

Removal of Bovine Insulin from US Market

The USP (United States Pharmacopeia) has revised the monograph for Isophane Insulin Suspension to remove references to bovine insulin due to the absence of approved manufacturers of therapeutic bovine insulin in the United States. This change reflects the shift towards using non-bovine insulin products, which are now the standard in clinical practice[2].

Market Analysis

Current Market Scenario

The insulin market has seen a significant shift towards recombinant human insulin and analog insulins, which offer more precise glycemic control and fewer side effects compared to traditional animal-derived insulins. As a result, the demand for Insulin Susp Isophane Beef has decreased, especially in regions where newer insulin formulations are widely available.

Competitive Landscape

The insulin market is highly competitive, with major players such as Novo Nordisk, Eli Lilly, and Sanofi dominating the landscape. These companies have transitioned their product portfolios to include more advanced insulin analogs, which have better pharmacokinetic profiles and reduced immunogenicity compared to traditional insulins like Insulin Susp Isophane Beef.

Projections and Future Outlook

Declining Demand

Given the regulatory changes and the preference for newer, more advanced insulin formulations, the demand for Insulin Susp Isophane Beef is expected to decline further. This trend is likely to continue as healthcare providers and patients opt for insulins with better efficacy and safety profiles.

Emerging Technologies

The future of insulin therapy lies in advanced technologies such as continuous glucose monitoring systems, closed-loop insulin delivery systems, and interoperable artificial pancreas systems. These innovations are being tested in various clinical trials and are expected to revolutionize diabetes management, making traditional insulins like Insulin Susp Isophane Beef less relevant[3].

Key Takeaways

• Regulatory Changes: The removal of bovine insulin from the US market reflects a global trend towards using non-bovine insulin products.
• Clinical Safety: Careful monitoring is necessary when transitioning patients between different types of insulin to avoid allergic reactions and other complications.
• Market Trends: The demand for Insulin Susp Isophane Beef is declining in favor of more advanced insulin analogs.
• Future Outlook: Emerging technologies in diabetes management are likely to further reduce the relevance of traditional insulins.

FAQs

Q: What is Insulin Susp Isophane Beef?

A: Insulin Susp Isophane Beef is an intermediate-acting insulin suspension made from zinc-insulin crystals and protamine sulfate, derived from beef.

Q: Why is the use of Insulin Susp Isophane Beef declining?

A: The use is declining due to regulatory changes, the absence of approved bovine insulin manufacturers in the US, and the preference for newer, more advanced insulin formulations.

Q: What are the potential risks when switching from Insulin Susp Isophane Beef to another insulin?

A: Patients may experience allergic reactions or require dosage adjustments, which should be carefully monitored to avoid hypoglycemia or hyperglycemia.

Q: What are some emerging technologies in insulin therapy?

A: Emerging technologies include continuous glucose monitoring systems, closed-loop insulin delivery systems, and interoperable artificial pancreas systems.

Q: Is Insulin Susp Isophane Beef still used in clinical practice?

A: While it is still available, its use is becoming less common as healthcare providers increasingly opt for more advanced and safer insulin formulations.

Sources

1. JAMA Network: Chronic Urticaria From Isophane Insulin Therapy
2. USP-NF: Isophane Insulin Suspension
3. Mayo Clinic Research: Type 1 Diabetes Clinical Trials
4. RxList: Novolin 70-30 Innolet
5. Federal Register: NDA 18–479. NPH Iletin II (insulin suspension isophane purified beef)