Adding Liraglutide to Insulin Regimen for People with Type 1 Diabetes Improved Glycemic Control

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 [email protected].

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). 

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.

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SOURCE American Diabetes Association