The leptin study is nationwide:
Questions & Answers
Q. What is the purpose of the study?
A. The main purpose of this study is to test how well an experimental drug called r-metHuLeptin
(Leptin) works in controlling blood sugar levels in overweight people with Type 2 diabetes. Animal
research suggests that Leptin may help control blood sugar levels by increasing your body's
response to the insulin it produces. In addition, research in humans shows that Leptin causes weight
loss which is also known to help control blood sugar levels. Therefore, the combination of these two
effects may make Leptin a good option for treating type 2 diabetes. Another purpose of this study is
to further determine how safe Leptin is and to learn more about its possible side effects.
Q. Who may participate in this study?
A. This study is for overweight adults who have been diagnosed with type 2 diabetes and treated
with oral medication for at least 4 months, but less than 6 years. Your treatment during the last 2
months must be with either glipizide (Glucotrol) or glyburide (e.g. Diabeta, Micronase or Glynase).
You must also have relatively stable blood glucose levels and be willing to maintain your present diet
during the course of the study. A dietician will help you with nutritional advice.
Q. What is Leptin?
A. Leptin is a natural hormone found in humans and animals. It is made in fat cells and released into
the blood stream where it is carried to different parts of your body. The Leptin used in this study will
be a man-made form of the hormone that has been shown to be effective in improving blood sugar
control and causing weight loss through effects on metabolism and appetite.
Q. How is Leptin taken?
A. Leptin is injected just below the surface of the skin using a syringe and needle. It will then be
absorbed by your body.
Q. Are there any risks or side effects of Leptin?
A. As with all medications, it is not possible to know all of the risks and side effects up front.
However, Leptin appears to be a relatively safe drug. Leptin has been tested in more than 250
volunteer research subjects, both healthy normal and overweight persons, and the most common
side effects have been skin reactions like redness, itching and inflammation where the drug was
injected. A smaller number of volunteers have reported headaches, fatigue and nausea.
Q. How many people will be in this study and what will I have to do?
A. There will be approximately 120 volunteer research subjects participating at about 15 centers in
the United States and Canada. Before participating in the study you will have to sign an informed
consent document which explains the details of the study. After signing, your responsibilities will be
to adhere to your diet, give yourself injections of the medication and show up for weekly visits at the
study site for tests and procedures. You will be in the study for a maximum of about 6 months which
includes a screening period of 7 to 56 days prior to receiving medication and a 4 month treatment
period.
Q. Is there any cost to participate in the study?
A. No, the study medication and all study related tests and procedures will be free.
Q. What's in it for me if I participate in the study?
A. First, you may benefit by receiving the results of free medical examinations, laboratory results,
and other tests and procedures performed during the study. Second, you will receive dietary
counseling and nutritional information from a dietician. Third, the treatment you receive may help you
control your blood sugar levels and may cause some weight loss. Finally, your participation in the
study may benefit society by contributing to the development of a new drug to treat diabetes.
Leptin Diabetes Trial Sites
California
Gail Thames, Study Contact
David Herber, MD, PhD, Investigator
University of California, Los Angeles
Center for Human Nutrition
900 Veteran Avenue, Box 951742
Los Angeles, CA 90095-1742
Telephone: 310/825-0453
Fax: 310/267-2036
E-mail: gthames@med1medsch.ucla.edu
Texas
Cynthia Morrison, Study Contact
Priscilla Hollander, MD, Investigator
Ruth Collins Diabetes Center
Baylor University Medical Center
3500 Gaston Avenue
Dallas, TX 75246
Telephone: 214/820-1552
Fax: 214/820-4840
Michigan
Ann Jensen, RN, Study Contact
Michael Doyle, MD, Investigator
William Beaumont Hospital
Preventative & Nutritional Medicine
390 Park Street
Birmingham, MI 48009-3428
Telephone: 248/646-6500
Fax: 248/645-8167
Washington
Susan Loewen, MSN, Study Contact
Daniele Porte, Jr., MD, Investigator
Veterans Affairs Medical Center
University of Washington
1660 South Columbian Way 151
Seattle, WA 98108
Telephone: 206/764-2328
Fax: 206/764-2438
New York
Portia Rindos, RN, Study Contact
Havey Katzeff, MD, Investigator
Long Island Jewish Medical Center
Clinical Research Division
Staff House 210A
270-05 76th Avenue
New Hyde Park, NY 11040
Telephone: 516/470-6906
Fax: 516/470-6903
Missouri
Tamara Stich, RN, MSN, CDE, Study Contact
Janet McGill, MD, Investigator
Washington University School of Medicine
660 South Euclid, Campus Box 8127
St. Louis, MO 63110
Telephone: 314/362-8616
Fax: 314/362-4833
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