Patient Information
In cooperation with the pharmaceutical industry, we perform clinical studies for the development and testing of investigational substances, drugs and medical products for diabetes and diabetes-related problems such as neuropathy and obesity. All studies are preapproved by the FDA. For more detailed information relating to clinical studies, watch the short video at right, or click the frequently asked questions below: Before a drug may be prescribed by a doctor, it must first be approved by the Food and Drug Administration (FDA). To obtain this approval, clinical studies must be carried out to establish the efficacy and safety of the drug. Here, it is essential that the studies are carried out in accordance with precisely defined rules and conditions. When the preclinical development phase has been completed successfully, i.e. in particular, on conclusion of the tests and experiments with animals, a new substance is tested on human subjects. This testing is divided into four phases: Phase I Studies: The drug that is to be tested is administered to healthy people, known as subjects. These are people who volunteer to test - within the framework of a clinical trial (study) - new medical agents or agents that have not yet been approved in the United States. Phase II Studies: In Phase II studies, the drug is, for the first time, tested on patients suffering from the illness that is to be treated with this drug. Phase II studies aim to gather information on the efficacy, safety and the dose/effect ratio of the medication. Phase III Studies: Here, the drug that is being tested is administered to a larger number of patients. The aim in this phase is to examine the efficacy of the drug in day-to-day use, the possible side effects and safety as well as any possible interactions between medications. Phase IV Studies: These studies are only carried out after a drug has been approved. A Phase IV study aims to gather further information relating to the benefits and risks associated with the drug as well as information on its use, for example, in other areas of application. If you are interested in taking part in a clinical study at our institute, please contact us:
We would be happy to return your call and provide you with detailed information in the course of a personal meeting, free of charge.
Call the Diabetes Research Center at the number below. The DRC office manager will answer and direct your call to the appropriate Coordinator, or to the Principal Investigator, Dr. Selam, if necessary. If you call after close of business, you will be prompted to leave a message, and the DRC will return your call the next business day.
714.734.7944
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