Background

Many patients with T2DM do not achieve sustained diabetes remission following obesity surgery. Liraglutide, a GLP-1 analogue, improves glycaemia and reduces body weight. Our aim was to evaluate the safety and effectiveness of Liraglutide 1•8 mg in patients with persistent or recurrent T2DM after surgery.

Methods

In this double-blind, placebo-controlled trial, adults with HbA1c >48 mmol/mol (>6•5%) at least one year after surgery were randomised 2:1 to once-daily subcutaneous Liraglutide 1•8 mg or Placebo, together with a reduced-calorie diet and increased physical activity. The primary outcome was the change in HbA1c from baseline to 26 weeks. EudraCT 2014-003923-23 and ISRCTN 13643081.

Results

Between February 2016 and November 2018, we assigned 80 patients to receive Liraglutide (n=53) or Placebo (n=27). Seventy-one (89%) participants completed the study (complete-cases population). Multivariable linear regression analysis with baseline HbA1c and surgery type as covariates showed that Liraglutide was associated with a difference in HbA1c change of -13•3 mmol/mol or -1•22%, 95% CI -19•7 to -7•0, p<0•001) vs Placebo at 26 weeks. Liraglutide was associated with a difference in the change of weight of -4•23 kg [95% CI -6•81 to -1•64, p<0•001) vs Placebo. No significant influence of type of surgery was noted. Adverse effects were mainly mild, gastrointestinal in nature and in line with previous experience with Liraglutide.

Conclusions

This is the first randomised controlled trial of adjunctive Liraglutide treatment in patients with T2DM after metabolic surgery. The results support the use of Liraglutide therapy in this clinical context.