In recent years, diabetes advocacy groups have called for greater attention to measures beyond glycated hemoglobin when evaluating diabetes drugs, because avoiding hypoglycemia and spending more time in range are important to health and quality of life.
A yearlong study presented at the 78th Scientific Sessions of American Diabetes Association found that adding liraglutide to insulin regimens for patients with type 1 diabetes (T1D) helps them to achieve better glycemic control and lose weight, without causing more incidents of hypoglycemia.
Liraglutide, the glucagon-like peptide-1 receptor agonist sold by Novo Nordisk as Victoza, had been shown to boost glycemic control and promote weight loss in T1D patients over a 12-week period, prompting researchers to pursue the longer study, which was presented in the late-breaking session June 24, 2018.
Improved control without increased hypoglycemia is a key finding, given the recent emphasis on measures beyond glycated hemoglobin (A1C) to gauge the effectiveness of diabetes medication. Leading researchers and patient advocacy groups have called on both the FDA and payers to give more attention to “time in range,” which measures how well a therapy helps T1D patient avoid the roller coaster effect that can occur with insulin. More work is being done to show how repeated incidents of hypoglycemia cause renal and retinal damage, which increases healthcare costs and reduces quality of life for people with T1D.
“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,” Paresh Dandona, MD, FRCP, FACP, FACC, FACE, a distinguished professor of medicine and pharmacology at the State University of New York in Buffalo and lead author of the study, said in a statement. “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."
The 52-week trial involved 46 patients with an average A1C of 7.82%. After randomization, 26 patients received 1.8 mg of liraglutide daily along with their usual insulin dose, and 20 patients were given placebo. Data from a continuous glucose monitor was gathered for 4 weeks before treatment and 4 weeks at the end.
Patients taking liraglutide showed greater improvement in blood glucose levels and blood pressure, and they lost significantly more weight. Those taking liraglutide saw their placebo-adjusted A1C drop to an average of 7.45%, and their weekly average blood glucose decreased from 175 mg/dL to 156 mg/dL. Fasting weekly glucose fell from 165 mg/dL to 153 mg/dL.
Researchers reported no change in incidences of hypoglycemia and no change in time spent below 70 mg/dL, the lower end of what is considered in a normal glycemic range. Patients’ total insulin dose did not change, either.
Patients taking liraglutide saw their average weight drop from 83.6 kg to 80.5 kg. The placebo-adjusted systolic blood pressure (BP) also dropped during treatment, from 128 mmHg to 122 mmHg, while placebo-adjusted diastolic BP fell from 79 mmHg to 75 mmHg.
“We conclude that the addition of liraglutide to insulin treatment in type 1 diabetes significantly reduced [A1C], mean and fasting blood glucose, blood pressure and body weight without significant increase in hypoglycemia,” the researchers wrote.
Dandona P, Ghanim H, Kuhadiya ND, et al. Liraglutide as an additional treatment to insulin in patients with type 1 diabetes mellitus—a 52-week randomized double-blinded placebo-controlled trial. Presented at the 78th American Diabetes Association Scientific Sessions, Orlando, Florida; June 24, 2018. Abstract 3-LB.