Page 8 - Diabetes

NEWS&

NOTES

FDA Approves
Ozempic for

Type 2 Diabetes

he U.S. Food and Drug Administration
T(FDA) approved a new medication that
promises not only to control blood sugar in
people with diabetes but also to help them
lose weight.
The drug, called Ozempic (sema-
glutide) is manufactured by Novo Nor-
disk and is designed to promote the
production of insulin in the body while
simultaneously suppressing appetite.
FDA approval is based on a global trial
comprised of eight clinical trials involv-
ing more than 8,000 adults with Type
2 diabetes. The program also evaluated
participants for cardiovascular safety and
found no risk.
According to the manufacturer, the
results of the trials showed “clinically
meaningful and statistically significant
STEM CELLS reductions” in blood glucose as measured
by A1C tests (a test that provides informa-
REVERSING TYPE I DIABETES tion about a person’s average levels of
blood glucose over the preceding three
months). In addition, treatment with Ozem-
esearchers at Boston Children’s Hos- protein called PD-L1, which has a strong pic resulted in reductions in body weight.
Rpital recently published the results anti-inflammatory effect. When intro- Ozempic comes in two dose sizes—
of research that could ultimately lead duced into the pancreas, the treated cells 0.5 mg (milligrams) and 1 mg. In one of
to a cure for Type 1 diabetes. bind to receptors on the T-cells. The the trials, participants who received a
The strategy behind the study is based T-cells either die or become inactive. lower dose lost an average of 9.5 pounds,
while those who received the higher dose
on the knowledge that Type 1 diabetes According to Paolo Fiorina, MD, senior
lost an average of 13.5 pounds.
occurs when T-cells from the immune investigator on the study, “There’s really
Ozempic is injected on the same
system attack beta cells in the pancreas— a reshaping of the immune system when day once a week and is combined with
the cells that produce insulin. you inject these cells.” diet and exercise. It can be used at any
Previously, one method used by Researchers tested the procedure on time of day with or without meals. Users
researchers to neutralize this attack is to mice and reported they reversed Type administer the injection themselves with
reboot a patient’s own immune system by 1 diabetes in the animals. All mice were a prefilled pen. The manufacturer recom-
mends that it be injected under the skin
infusing that patient with his or her own cured of diabetes temporarily, and one-
of either the stomach, the thigh or the
blood stem cells through an autologous third of them were cured for the rest of
upper arm, and the injection site should
bone marrow transplant. The problem their lives. be rotated with each weekly dose. The
has been that the blood stem cells of The next step is to try the treatment on cost is about the same as other once-
people with diabetes tend to be defec- people with diabetes. Accordingly, Boston daily injection medications.
tive, which can promote inflammation. Children’s researchers are partnering According to Helena Rodbard, MD,
Researchers at Boston Children’s with a California therapeutics firm to a former president of the American
Association of Clinical Endocrinologists,
Hospital, however, said they found a way refine the procedure for modifying the
“The approval of semaglutide offers
to fix the defect in the patient’s blood blood stem cells and then to begin a trial
health-care professionals an important
stem cells. They do this by treating the in humans. According to Fiorina, “The new treatment option to help adults with
blood stem cells with small molecules beauty of this approach is the virtual lack Type 2 diabetes meet their A1C goals.” Shutterstock/Juan Gaertner
or with gene therapy. The treatment of any adverse effects, since it would use Next up is a trial of the drug on patients
stimulates the cells to produce more of a the patient’s own cells.” † under 18.†
6 March/April 2018