Adding liraglutide to basal insulin significantly improved glycemic control in patients with type 2 diabetes, with or without metformin, according to research presented at the 50th European Association for the Study of Diabetes Annual Meeting.
Greater weight loss and reductions in systolic blood pressure and selected lipids were also seen with liraglutide (Victoza, Novo Nordisk) compared with placebo in a multicenter, multinational randomized controlled trial.
“This once-daily therapy is a good choice when patients fail basal insulin therapy because it effectively lowers glucose without the complexity, weight gain and even higher rate of hypoglycemia one would expect in progressing to basal-bolus therapy,” Andrew Ahmann, MD, of Oregon Health & Science University in Portland, told Endocrine Today.
Ahmann, along with Jorma Lahtela, MD, PhD, of Tampere University Hospital, Finland, and colleagues, looked for superior efficacy and acceptable safety in 451 patients (aged 18-80 years; BMI 20-45 kg/m2; HbA1c 7-10%). Patients already on stable insulin analog doses ≥20 U/day, with or without stable metformin treatments ≥1,500 mg/day, were eligible.
In a double blind, parallel-group design, the researchers analyzed 225 patients treated with liraglutide 1.8 mg daily and 225 with placebo added to pre-existing therapy for 26 weeks; insulin adjustments above the pre-trial dose were not allowed.
With similar mean baseline characteristics in liraglutide and placebo groups, patients with liraglutide had greater reductions in HbA1c compared with placebo (–1.3 vs. –0.11; 95% CI, –1.39 to –0.99).
The proportion of patients who reached HbA1c <7% was greater with liraglutide vs. placebo (59.2% vs. 14%; P<.0001), as was the proportion reaching HbA1c ≤6.5% (42.9% vs. 3.6%; P<.0001) using a lower mean estimated daily dose of basal insulin analogue (35.8 U vs. 40 U).
With liraglutide compared with placebo, patients also achieved greater reductions in fasting plasma glucose (difference, –1.28 mmol/L; 95% CI, –1.7 to –0.86), incremental post-prandial self-measured plasma glucose (difference, –0.57 mmol/L; 95% CI, –0.94 to –0.2), body weight (difference, –3.11 kg; 95% CI, –3.85 to –2.37), systolic BP (difference, –5.02 mm Hg; 95% CI, –7.45 to –2.59) and lipids.
Nausea was reported in 22.2% of those assigned liraglutide vs. 3.1% in the placebo group, vomiting occurred in 8.9% of the liraglutide group vs. 0.9% in the placebo group, and minor hypoglycemia events occurred in 18.2% of patients with liraglutide vs. 12.4% with placebo.
“Hypoglycemia occurs more frequently with the addition of liraglutide due to the lower ambient glucose level HbA1c in the presence of insulin,” Ahmann said. “However, no severe hypoglycemic episodes were noted.”
For more information:
Lahtela J. Abstract #37. Presented at: 50th EASD Annual Meeting; Sept. 16-19, 2014; Vienna.
Disclosure: The study was supported by Novo Nordisk