PHILADELPHIA, PA, Jun 09, 2012 (MARKETWIRE via COMTEX) —
Children diagnosed with type 2 diabetes appear to experience a more
rapidly progressive disease than people who are diagnosed as adults,
with a higher rate of early complications and a relatively early need
for combination therapy or insulin, according to research results
from the largest, and only, longitudinal study of its kind to date,
of children with diabetes, presented at the American Diabetes
Association’s 72nd Scientific Sessions(R).
The Treatment Options for Type 2 Diabetes in Adolescents and Youth
(TODAY) study, which was designed to test the efficacy and safety of
diabetes medications for young people, was also able to identify
which group of children would be able to manage their diabetes and
which would face more rapid progression of the disease based on their
initial response to metformin treatment. Researchers found that those
who had good glycemic control (as evidenced by A1C levels in the
normal range) after two to four months on metformin during the
pre-randomization period were more likely to maintain that control
for at least 48 months than those whose A1C levels were greater than
6.1 percent after the first few months of treatment on metformin.
“The good news is nearly 50 percent of the kids did well on metformin
therapy,” said Phil Zeitler, MD, PhD, TODAY study Chair and Professor
of Pediatrics at the University of Colorado. “For the other 50
percent, we need to focus on what type of treatment is best for them
and at this point, the only well-studied option is combination with
insulin.”
The study was designed to also test the efficacy and safety of
rosiglitazone as a treatment for youth with type 2 diabetes, finding
that combining metformin with rosiglitazone reduced the need to
transition young patients to insulin therapy by 25 percent. However,
because use of this drug has since been limited by the U.S. Food and
Drug Administration due to safety concerns, researchers said they
could not recommend its use in children. Initial results from the
TODAY study, showing that nearly 50 percent of youth with type 2
diabetes needed insulin therapy within a few years of diagnosis, were
released at the end of April.
“Despite our positive findings that combining metformin with
rosiglitazone helped more of these kids to maintain glycemic control,
and the fact that we had no safety issues with the patients in our
study, we cannot recommend that youth use this therapy because
rosiglitizone is essentially off the market today,” said Investigator
Lori Laffel, MD, MPH, Chief of the Pediatric, Adolescent and Young
Adult Section at the Joslin Diabetes Center in Boston. “We can
clearly say this disease is different in kids and we need to be more
aggressive about beginning multiple therapies to preserve beta cell
function and to prevent deterioration of A1C and blood glucose
levels.”
What those therapies should be, however, must be the focus of future
investigations.
The TODAY study results emphasize the critical need for new
treatments for youth by revealing the high rate of co-morbidities
that manifest within a relatively short duration of living with the
disease. Nearly one-third of the children in the study exhibited high
blood pressure by the end of the study’s mean follow-up of just under
four years (compared to just 12 percent at the beginning of the
study); and close to 17 percent exhibited elevated urinary albumin
levels, an early marker of kidney disease (up from six percent at the
beginning of the study). Roughly 13 percent of those in the study
exhibited signs of eye disease, “which is relatively high after such
a short duration of disease,” Laffel said.
“The biggest concern with diabetes is the consequences in terms of
cardiovascular disease and microvascular disease and these kids are
at very high risk at young ages,” Zeitler said. “Within the next
10-20 years, many of these kids will have substantial health
problems. This suggests a major health burden in the future.”
The TODAY study looked at 699 youth with type 2 diabetes at 15 health
centers across the U.S., with a follow-up period of two to six years.
Patients were between 10 and 17 years old when entered into the study
and had been diagnosed within the past two years. They were separated
into three treatment arms: one treated with metformin only; one with
metformin plus rosiglitazone; and one with metformin plus intensive
lifestyle changes. There was no difference in results between the
metformin-only group and those who also received an intensive
lifestyle change program.
Press Conference: Friday, June 8, 11 a.m. ET
The American Diabetes Association is leading the fight to Stop
Diabetes and its deadly consequences and fighting for those affected
by diabetes. The Association funds research to prevent, cure and
manage diabetes; delivers services to hundreds of communities;
provides objective and credible information; and gives voice to those
denied their rights because of diabetes. Founded in 1940, our mission
is to prevent and cure diabetes and to improve the lives of all
people affected by diabetes. For more information please call the
American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or
visit
www.diabetes.org . Information from both these sources is
available in English and Spanish.
Contact:
Christine Feheley
(703) 253-4374
Colleen Fogarty
(703) 549-1500, ext. 2146
News Room: June 8-12, 2012
Room 107, Pennsylvania Convention Center
(215) 418-2030
SOURCE: American Diabetes Association
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