In adults with prediabetes, liraglutide as an adjunct to diet and exercise was effective for delaying the progression to type 2 diabetes, as well as for reducing body weight and fasting plasma glucose, according to findings presented at the 52nd European Association for the Study of Diabetes Annual Meeting.
Sten Madsbad, MD, DMSc, chief physician in the department of endocrinology at Hvidovre Hospital in Hvidovre, Denmark, and colleagues evaluated data from the SCALE obesity and prediabetes trial on 2,254 adults (mean age, 47.5 years; 76% women) with prediabetes and overweight or obesity. Participants were randomly assigned to subcutaneous liraglutide (Victoza, Novo Nordisk) 3 mg once per day or placebo.
“All participants were also treated with a lifestyle intervention with a caloric deficit of about 500 kcal per day, and participants were expected to perform 30 minutes of physical activity per day,” Madsbad said during his presentation.
Follow-up was conducted for 3 years.
Participants were divided into four groups based on baseline BMI: 27 kg/m2 to 29.9 kg/m2 (liraglutide, n = 39; placebo, n = 23), 30 kg/m2 to 34.9 kg/m2 (liraglutide, n = 415; placebo, n = 912), 35 kg/m2 to 39.9 kg/m2 (liraglutide, n = 480; placebo, n = 243) and 40 kg/m2 or higher (liraglutide, n = 538; placebo, n = 280).
Over 3 years, fewer participants in the liraglutide group developed type 2 diabetes (3%) compared with the placebo group (11%). The estimated time to onset of type 2 diabetes was 2.7 times longer in the liraglutide group compared with the placebo group at week 160 (P < .0001).
The liraglutide group had greater reductions in body weight (mean, 6.17%) compared with the placebo group (mean, 1.84%). The liraglutide group experienced a reduction of 0.37 mmol/L for fasting plasma glucose, whereas it was unchanged in the placebo group.
“There were no clear patterns regarding total and serious adverse events across the BMI subgroups,” Madsbad said. “The rates of gastrointestinal and hypoglycemic events were higher in the patients treated with liraglutide, but did not differ between the four BMI subgroups.”
He added that low rates of pancreatitis and neoplasms occurred in all BMI subgroups.
“Liraglutide 3 mg compared with placebo improved glycemic control, beta-cell function and insulin sensitivity across all BMI subgroups,” Madsbad said. “There is no indication that the effect of liraglutide 3 mg on glycemic control and beta-cell function differ between the four BMI subgroups. Liraglutide 3 mg was generally well tolerated in all BMI subgroups.” – by Amber Cox
Madsbad S, et al. OP 77. Presented at: 52nd EASD Annual Meeting; Sept. 12-16, 2016; Munich.
Disclosure: Madsbad reports various financial ties with AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Merck Sharp & Dohme, Novartis Pharma, Novo Nordisk and Sanofi Aventis.