SAN DIEGO — Liraglutide 3 mg, when combined with diet and exercise, reduced fasting and postprandial glucose in patients with overweight or obesity without type 2 diabetes more than diet and exercise alone, according to research presented at The Endocrine Society annual meeting.
Clinically significant hypoglycemia with glucose below 56 mg/dL was rare with both liraglutide 3.0 mg and placebo treatments, and there were no reports of severe hypoglycemia defined as requiring third-party intervention.
“Liraglutide 3.0 mg is an effective agent that helps overweight and obese people lose weight without causing low blood sugars,” David C. Lau, MD, PhD, of the University of Calgary, Alberta, Canada, told Endocrine Today. “For those people with prediabetes, liraglutide 3.0 mg reduces blood sugar in addition to weight loss.”
David C. Lau
Lau and colleagues evaluated the effects of liraglutide on glycemic excursions and hypoglycemia in adults with overweight and obesity, but not type 2 diabetes, from the 56-week SCALE Obesity and Prediabetes trial; individuals with BMI at least 27 kg/m2 and at least one comorbidity or BMI at least 30 kg/m2 were eligible.
The investigators randomized patients (mean age, 45 years; body weight, 106.2 kg; BMI, 38.3 kg/m2; 78.5% female, 61.2% with prediabetes) in a 2:1 ratio to once-daily liraglutide 3.0 mg (n = 2,487) or placebo (n = 1,244) in addition to a deficit diet (500 kcal/day) and increased physical activity (≥ 150 minutes/week).
The researchers assessed changes in fasting plasma glucose and postprandial plasma glucose, based on oral glucose tolerance test (OGTT), at baseline and week 56.
Hypoglycemic events were reported as adverse events (AEs) in two ways: self-reported by patients based on spontaneous, not biochemically confirmed, symptoms between visits; identified by investigators during scheduled visits, based on glucose values of < 70 mg/dL, including OGTT, regardless of paleness, shaking, sweating, increased pulse/heartbeat, hunger, vision disorder, unusual behavior or drowsiness.
With liraglutide compared with placebo, patients demonstrated greater decreases in body weight (–8.0% vs. –2.6%), fasting plasma glucose (–7.1 mg/dL vs. 0.1 mg/dL) and postprandial plasma glucose (–46.8 mg/dL vs. –10.4 mg/dL) from baseline to week 56, based on last observation carried forward (P < .0001, ANCOVA).
Further, the improvements seen in glycemia were more pronounced in those with prediabetes than without.
“Liraglutide 3.0 mg was a safe and effective anti-obesity agent in overweight and obese people with or without prediabetes,” Lau said. – by Allegra Tiver
Lau DC. Abstract OR07-2. Presented at: The Endocrine Society Annual Meeting; March 5-8, 2015, San Diego.
Disclosure: Lau reports relationships with Amgen, Astra Zeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly & Company, Janssen, Merck & Co, Novo Nordisk, Roche Pharmaceuticals and Valeant.