GETTING STARTED

What is a Type II Diabetes Study?

Millions of people have been diagnosed with Type II diabetes and many more are unaware that they have it. Unfortunately, Type II diabetes can lead to important medical complications such as heart disease, eye complications, and skin disorders. Several new medications are being tested to treat Type II diabetes or the complications associated with this disease. To determine how well these new medications work, they must be tested against a placebo or against another medication that has already been shown to be safe and effective. The Type II Diabetes studies conducted by Jean Brown Research are designed to test how well new medications work for people with Type II diabetes.

About These Trials

The study procedures and process will vary depending on the specific type of Type II diabetes trial you participate in; the process and all procedures for that study will be explained to you before you enroll in the study. To begin a study, you will come to the research center for a screening visit. At this visit the Investigator will perform a physical examination and will ask you questions about your medical history and about medications you take for your Type II diabetes and other medical conditions. A urine sample and blood sample will be taken. If you are eligible to participate in the study, the Investigator or study nurse will give you instructions that you will need to follow for the remainder of the study. For most studies, you will be asked to return to the research center at regularly scheduled intervals. At each study visit your health will be checked and the effects of the medication you are using will be assessed. Throughout the study, the Study Coordinator and the Principal Investigator will assist you and can answer any questions you have.

The Study Medication

The study medication you receive will vary depending on the specific Type II diabetes study you are participating in. The Investigator or Study Coordinator will administer the study medication at the research center and/or will provide you with detailed instructions for how to self-administer the study medication at home.

Steps for Qualifying

To participate in a clinical trial, an individual must meet certain guidelines that are determined before the study starts. These guidelines, called study entry criteria, are used to identify appropriate subjects for the study and to keep them safe during the study.

The first step in qualifying for the study is to talk to an enrollment specialist who will ask you a list of questions to determine whether you will qualify for the study. If these criteria are met, you will be asked to come to the research center where the Investigator will perform a physical examination and will ask you some questions about your medical history and medications you are taking to make sure you meet all of the study entry criteria. The Study Coordinator or Investigator will explain the study in detail and will answer any questions you might have. If you decide to participate in the study, you must sign a written informed consent to participate.

The Study Commitment

You will be required to make a certain number of visits to the research facility depending on the type of study you participate in. The first visit will be a screening visit during which the Investigator will examine you and make sure you are eligible for the study. Within a certain number of days of the screening visit, you will return to the research center for another study visit. You may be asked to return to the research center for additional study visits. The number of visits you are required to make and the duration of each visit will depend on the specific Type II diabetes trial that you are participating in. Some of the studies will require you to keep a study diary where you record specific information throughout the study.

Potential Benefits

People who participate in a Type II diabetes clinical trial will receive medical care and treatment at no cost to them. They may also receive compensation for their time and travel.