ORLANDO, Fla., June 24, 2018 /PRNewswire-USNewswire/
-- Adults with type 1 diabetes (T1D) who take a daily dose of
liraglutide demonstrated improvements in HbA1c levels, weekly
average blood glucose levels and increased weight loss, according
to the study, "Liraglutide as an Additional Treatment to Insulin in
Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized
Double-Blinded Placebo-Controlled Clinical Trial," presented today
at the American Diabetes Association's® (ADA's) 78th
Scientific Sessions® at the Orange County Convention Center.
Many patients with T1D struggle to maintain glycemic control in
their target range and thus, are vulnerable to serious
diabetes-related complications. A prior study (Dandona, 2012) of
daily liraglutide for 12 weeks indicated a positive impact on
glycemic control, weight loss and systolic blood pressure,
therefore subsequent studies have been conducted.
This double-blind, placebo-controlled, randomized, one-year
trial examined the effects of liraglutide on multiple health
parameters in people with T1D. A total of 46 adults (average age
47.6 years) with T1D participated in the study. At the beginning of
the trial, the patients had an average HbA1c level of 7.82, and an
average body mass index of 28.9 Kg/m2. The patients were
randomized, and 26 patients received daily injections of 1.8 mg of
liraglutide, while 20 patients received daily injections of a
placebo. Continuous glucose monitoring (CGM) was performed for four
weeks before treatment and at the end of treatment.
At the completion of 52 weeks, the patients who had taken
liraglutide showed improvements in blood glucose levels, weight and
blood pressure. The liraglutide group had a placebo-adjusted,
average HbA1c decrease to 7.45 (p=0.009), and a weekly
placebo-adjusted average blood glucose decrease from 174 to 156
mg/dl (p=0.021). There were no changes in reported incidences of
hypoglycemia and no changes in percent of time spent below 70mg/dl
based on CGM, and the patients' total insulin dose did not alter.
Additionally, the liraglutide group had significant weight loss,
from an average of 83.6 kg to 80.5 kg (p=0.01). Placebo-adjusted,
average systolic blood pressure also decreased following
liraglutide treatment, from 128 mmHg to 122 mmHg, while
placebo-adjusted, diastolic blood pressure averages decreased from
79 mmHg to 75 mmHg.
"The magnitude of improvement in blood glucose control in our
study was significant, and this medication could have a positive
impact on the lives of people with type 1 diabetes," said lead
study author Paresh Dandona, MD,
FRCP, FACP, FACC, FACE, head of the division of endocrinology and
distinguished professor of medicine and pharmacology at
State University of New York at
Buffalo. "Because the number of patients with adequate
control of type 1 diabetes is small, the availability of an
additional, effective drug like liraglutide could contribute
greatly to the prevention of complications, improve quality of
life, and make patients' lives more stable and predictable."
To speak with Dr. Dandona, please contact the ADA Press Office
on-site at the Orange County
Convention Center on June 22 - 26, by
phone at 407-685-4010 or by email at press@diabetes.org.
The American Diabetes Association's 78th Scientific Sessions, to
be held June 22-26, 2018, at the
Orange County Convention Center in
Orlando, is the world's largest
scientific meeting focused on diabetes research, prevention and
care. During the five-day meeting, more than 16,000 health care
professionals from around the world will have exclusive access to
more than 3,000 original diabetes research presentations,
participate in provocative and engaging exchanges with leading
diabetes experts, and can earn Continuing Medical Education (CME)
or Continuing Education (CE) credits for educational sessions. The
program is grouped into eight theme areas: Acute and Chronic
Complications; Behavioral Medicine, Clinical Nutrition, Education
and Exercise; Clinical Diabetes/Therapeutics;
Epidemiology/Genetics; Immunology/Transplantation; Insulin
Action/Molecular Metabolism; Integrated Physiology/Obesity; and
Islet Biology/Insulin Secretion. Felicia
Hill-Briggs, PhD, ABPP, President of Health Care and
Education, will deliver her address, "The American Diabetes
Association in the Era of Health Care Transformation," on
Saturday, June 23, and Jane E.B. Reusch, MD, President of Medicine and
Science, will present her address, "24/7/365 – Lifetime with
Diabetes," on Sunday, June 24. In
total, the 2018 Scientific Sessions includes 375 oral
presentations; 2,117 poster presentations, including 47 moderated
poster discussions; and 297 published-only abstracts. Join the
Scientific Sessions conversation on social media using
#2018ADA.
About the American Diabetes Association
Nearly half of
American adults have diabetes or prediabetes; more than 30 million
adults and children have diabetes; and every 21 seconds, another
individual is diagnosed with diabetes in the U.S. Founded in 1940,
the American Diabetes Association (ADA) is the nation's leading
voluntary health organization whose mission is to prevent and cure
diabetes, and to improve the lives of all people affected by
diabetes. The ADA drives discovery by funding research to treat,
manage and prevent all types of diabetes, as well as to search for
cures; raises voice to the urgency of the diabetes epidemic; and
works to safeguard policies and programs that protect people with
diabetes. In addition, the ADA supports people living with
diabetes, those at risk of developing diabetes, and the health care
professionals who serve them through information and programs that
can improve health outcomes and quality of life. For more
information, please call the ADA at 1-800-DIABETES (1-800-342-2383)
or visit diabetes.org. Information from both of these sources is
available in English and Spanish. Find us on Facebook (American
Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram
(@AmDiabetesAssn).
3-LB
|
Liraglutide as an
Additional Treatment to Insulin in Patients with Type 1 Diabetes
Mellitus—A 52-Week
Randomized Double-Blinded Placebo-Controlled Clinical
Trial
|
78th Scientific Sessions
News
Briefing: Adjunctive Therapies in Type 1 and Type 2 Diabetes,
Sunday, June 24, 7:15 a.m. ET
Session Type: Moderated Poster Discussion
Session Title: Evolving Concepts in Clinical Management
Strategies
Location: Exhibit Hall (ePoster Theater A)
Session Time: Sunday, June 24,
2018, 12:00 noon - 1:00 pm
Presentation Number: 3-LB
Session Type: Late Breaking Poster Session
Session
Title: Late Breaking Poster Session
Location: Poster
Hall
Session Time: Monday, June 25,
2018, 12:00 noon - 1:00 pm
Presentation Number: 3-LB
Abstract Title: Liraglutide as an Additional Treatment to
Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week
Randomized Double-Blinded Placebo-Controlled Clinical Trial
PARESH DANDONA, HUSAM
GHANIM, NITESH D. KUHADIYA, TANVI
SHAH, JEANNE M. HEJNA,
ANTOINE MAKDISSI, MANAV BATRA, AJAY
CHAUDHURI, Williamsville, NY, Buffalo,
NY, Reno, NV
We have previously demonstrated that a 12-week addition of
liraglutide to insulin therapy in patients with type 1 diabetes
(T1D) results in an improvement in glycemic control, weight loss
and a reduction in systolic blood pressure (SBP). We have now
conducted a 1 year randomized study investigating effects of
liraglutide in patients with T1DM. All patients had T1D for at
least one year, were on insulin therapy and had no detectable
c-peptide in plasma (mean BMI: 28.9±1.4kg/m2, mean
HbA1c: 7.82±0.16%, mean age: 46.7±1.9 years, mean age of T1D
diagnosis: 22.3±1.7 years). They were randomized to receive
placebo, (n=20) or 1.8mg Liraglutide (n= 26) daily for 52 weeks.
Continues glucose monitoring (CGM) was performed for 4 weeks before
and at end of treatment. At the end of 52 weeks treatment with
liraglutide, placebo adjusted HbA1c fell significantly by
0.57±0.17% (p=0.006 vs. placebo) from 7.920.15± to 7.45±0.12%
(p=0.009). Weekly placebo adjusted average blood glucose fell by
15±4mg/dl (p=0.014 vs. placebo) from 174±5 to 156±6mg/dl (p=0.021)
and fasting weekly glucose fell by 8±7mg/dl (p=0.075 vs. placebo)
from 165±7 to 153±9mg/dl (p=0.032). There was no change in reported
incidences of hypoglycemia and no change in percent time spent
below 70mg/dl based on CGM. Total insulin dose did not alter. There
was a significant weight loss by 2.5±0.9kg (placebo adjusted,
p=0.041 vs. placebo) from 83.6±4.1 to 80.5±4.0kg (p=0.01) in the
liraglutide group. Placebo corrected SBP also fell following
liraglutide treatment by 9±3mmHg (p=0.031) from 128±3 to 122±3 mmHg
while placebo adjusted diastolic BP fell by 5±1mmHg from (79±2 to
75±2mmHg). We conclude that the addition of liraglutide to insulin
treatment in type 1 diabetes significantly reduced HbA1c, mean and
fasting blood glucose, blood pressure and body weight without
significant increase in hypoglycemia.
Author Disclosures: P.
Dandona: Advisory Panel; Self; AstraZeneca. Consultant;
Self; AstraZeneca. Research Support; Self; AstraZeneca. H.
Ghanim: None. N.D. Kuhadiya: Speaker's
Bureau; Self; AstraZeneca, Novo Nordisk A/S, Janssen Scientific
Affairs, LLC. Advisory Panel; Self; AstraZeneca. Consultant; Self;
Dexcom, Inc. T. Shah: None. J.M.
Hejna: None. A. Makdissi: Speaker's Bureau;
Self; Eli Lilly and Company. M. Batra: Speaker's
Bureau; Self; Eli Lilly and Company. A.
Chaudhuri: Speaker's Bureau; Self; AstraZeneca, Eli Lilly
and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Merck
& Co., Inc., Novo Nordisk Inc.
Press Office in Orlando
June 22 - 26, 2018
407-685-4010
Contact:
Michelle Kirkwood
(703) 299-2053
mkirkwood@diabetes.org
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SOURCE American Diabetes Association