Clinical trial of new diabetes drug at UTHCT seeks to enroll people with type 2 diabetes

Friday, January 20, 2006

A new diabetes drug that also lowers cholesterol and fatty acids in the blood is the subject of a new clinical trial at The University of Texas Health Science Center at Tyler.

“The new drug lowers blood sugar and it lowers triglycerides - fatty acids - and cholesterol, too. This is the first time one class of drugs has been able to treat both high blood sugar and high triglycerides and cholesterol,” said David Shafer, MD, director of the Center for Diabetes Care at UTHSCT. High levels of triglycerides have been linked to hardening of the arteries and thus to a higher risk of heart attack and stroke.

The new oral drug is designed to treat type 2 diabetes. This is a disease that usually appears in adulthood; obesity and an inactive lifestyle tend to make it worse. Type 2 diabetes typically is treated with diet, exercise, and oral drugs such as metformin, Dr. Shafer said. He is UTHSCT’s principal investigator in this clinical trial, which is funded by the new drug’s maker, GlaxoSmithKline.

To be eligible for this clinical trial, people must have type 2 diabetes. They must be controlling their disease with diet and exercise alone, or with diet, exercise, and metformin, which is also known by the brand name Glucophage. Someone being treated with insulin would not be eligible for this study.

“Only major medical centers get to participate in this international clinical trial,” Dr. Shafer said, adding that the Health Center is the only institution in this region conducting the study.

This is a Phase III study, meaning it is being given to a large number of people to make sure the investigational drug is both safe and effective, he said. This is the last stage of the clinical trial process. After evaluating the results of this study, the U.S. Food and Drug Administration will decide whether to approve the drug.

“No drug makes it to the market unless there are volunteers who are willing to be part of clinical trials. Every person with diabetes who is taking a drug owes a debt of gratitude to people enrolled in previous studies who helped get those drugs approved. That’s how new drugs make it to the market,” Dr. Shafer said.

Participants in this trial will have access to new drugs for diabetes before these drugs become available to the public, he said. If a person’s diabetes is not under control, he or she has an opportunity to try a new drug right away, rather than having to wait until it is approved.

This clinical trial will last 16 weeks. Individuals who want to participate will first undergo a free physical and lab work to determine if they are eligible for the study. If they enroll in the study, treatments will be provided at no cost. This is a randomized study, which means participants will either receive the investigational drug or a placebo. Neither physicians nor participants will know who is getting the new drug and who the placebo.

“If we gave everyone the drug, we wouldn’t know why their diabetes got better. It could be due to chance, a change in their lifestyle, or the new drug,” Dr. Shafer said. “We need to be sure that drugs really do what the drug companies say they do. Using a placebo in tests of new drugs is the best way to ensure that our drugs are safe and effective.”

Participants’ blood sugar and cholesterol will be monitored, and they will be asked to report any side effects from the drug, Dr. Shafer said. Participants who are receiving metformin will continue to receive it. At the study’s conclusion, participants will learn if they received the drug or a placebo.

“One of the best ways to be familiar with cutting-edge treatments for diabetes is for both physicians and patients to participate in clinical trials,” he said. “Participants also will have the opportunity to contribute to medical knowledge. They will become part of something bigger than just themselves and their disease.”

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