Diabetes Clinical Trial Update



Diabetic clinical trials are an important element of battling diabetes.

What are clinical trials?

Basically a clinical trial is a scientific research involving people, that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

In the United States, clinical trials are monitored by the Food and Drug Administration.

The Phases of a Clinical Trial:

Phase I evaluates dosage parameters.

Phase II continues to evaluate safety and begins to study efficacy.

Phase III compares the new drug with standards of care or if there are none, a placebo.

Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.

Diabetes clinical trials may involve studies of prevention of diabetes or the treatment of types of diabetes.

So you know what Insulin is…but have you heard of Oral-Lyn?

“Generex Oral-lyn™, is an insulin spray for the treatment of Type I and Type II diabetes. Generex Oral-lyn™ is a safe, simple, fast, effective, and pain-free alternative to subcutaneous injections of prandial insulin and is conveniently delivered to the membranes of the oral cavity by a simple asthma-like device with no pulmonary (lung) deposition.”

The product is currently available in Ecuador and India and Phase III clinical studies have begun around the world.

Today Market Watch released information on the enrollment of more than 150 patients in these Phase III trials. ” The objective of the six-month study is to compare the efficacy of Generex Oral-lyn and the Company’s RapidMist(tm) Diabetes Management System with prandial injections of regular human insulin as measured by HbA1c. ”

The Environmental Determinants of Diabetes in the Young (TEDDY)

“The long-term goal of the TEDDY study is the identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors, which trigger type 1 diabetes in genetically susceptible individuals or which protect against the disease. The TEDDY study will recruit and enroll individuals, including obtaining informed consent from parents prior to or shortly after birth, obtain genetic and other samples from neonates and parents, and prospectively follow selected neonates throughout childhood or until development of islet autoimmunity or type 1 diabetes.”

CTLA-4 Ig (Abatacept) in Recent Onset Diabetes

From TrialNet:

“Abatacept was approved by the U.S. Food and Drug Administration (FDA) in December 2005 for the treatment of rheumatoid arthritis, another autoimmune disease. Abatacept works by interrupting one of the steps in the autoimmune attack.

In this study, we will see if abatacept will interrupt the autoimmune attack that is going on in people recently diagnosed with type 1 diabetes.”

Abatacept is given through a continuous IV infusion over for 30 minutes. Candidates for this study must be 6 to 45 years old, and diagnosed with type 1 diabetes less than 3 months ago. Check out the Trial Net site for more information.

ACT-Albuquerque Clinical Trials are enrolling for a diabetes study sponsored by Bristol Myers Squibb and involves a new compound combination with Metformin and/or TZD and/or Insulin therapy. Now enrolling patients ages 18-77 with the intention of assessing the effects of lowering blood sugars by management of diabetic medications. Check out the site contact to see if you qualify.

In depth resources on clinical trials and registries for clinical trials:

ClinicalTrials.gov not only lists registries of current clinical trials in the U.S and other countries but breaks them down according to condition, drug, sponsor and location.

World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”

CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”

Center Watch: Clinical Trials Listing Service. This site provides a notification services for new clinical trials.

American Diabetes Association provides basic information on clinical trials.

Juvenile Diabetes Research Foundation International lists current JDRF funded clinical studies and provides information on what phase those studies are currently in.

The Children With Diabetes site lists current clinical trials.

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NOTE: The contents in this blog are for informational purposes only, and should not be construed as medical advice, diagnosis, treatment or a substitute for professional care. Always seek the advice of your physician or other qualified health professional before making changes to any existing treatment or program. Some of the information presented in this blog may already be out of date.
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