This 26-week randomised trial investigated the efficacy, tolerability and safety of once-daily liraglutide 1.8 mg (LIRA) vs placebo (PLAC) added to pre-existing basal insulin analogue ±metformin in patients with inadequately controlled type 2 diabetes. Mean baseline characteristics were similar between the two groups (LIRA; PLAC): HbA1c 8.2; 8.3%, BMI 32.3; 32.2 kg/m2, diabetes duration 12.1 years, and stable insulin analogue dose 40.5 U. Following randomisation, insulin adjustments above pre-trial dose were not allowed. After 26 weeks, patients taking LIRA had a greater decrease in HbA1c from baseline than PLAC, and more LIRA patients reached HbA1c <7.0%. Patients taking LIRA also achieved greater decreases from baseline in fasting plasma glucose, body weight and systolic blood pressure (‑5.78 mmHg) vs PLAC (‑0.76 mmHg). Nausea and vomiting adverse events occurred more frequently with LIRA than PLAC (22.2% vs 3.1% and 8.9% vs 0.9%, respectively). Minor hypoglycaemia (plasma glucose <3.1 mmol/L [56 mg/dL]) occurred in 18.2% and 12.4% of the LIRA and PLAC groups, respectively. No severe hypoglycaemic events were reported.
In conclusion, the addition of LIRA to basal insulin analogues significantly improved glycaemic control and induced greater weight loss compared to PLAC. Typical gastrointestinal symptoms and minor hypoglycaemia were more frequent with LIRA than PLAC.