The outcomes from a pilot randomised controlled trial have revealed that the addition of the GLP-1 agonist receptor liraglutide after laparoscopic adjustable gastric banding (LAGB) did not significantly improve HbA1c or weight compared to placebo at six months, according to UK researchers. However, they noted that the trial was underpowered to detect a significant difference between groups in the primary and secondary endpoints.
Although the literature has shown that LAGB has lower weight reduction than other bariatric procedures, the investigators wanted to assess the efficacy and safety of liraglutide 1.8mg in participants undergoing LAGB.
The GLIDE trial was a pilot randomised, double-blind, placebo-controlled trial, evaluating LAGB with either liraglutide 1.8mg or placebo in participants with T2DM and obesity. Participants were randomised (1:1) to six-months therapy post-LAGB, with further six months off-treatment follow-up. The primary outcome was change in HbA1c from randomisation to the end of treatment, secondary outcomes included body weight change. A sample size of 58 (29 per group) had 80% power to detect a 0.6% difference in HbA1c between groups.
In total, 27 participants were randomised to liraglutide (n=13) or placebo (n=14). Multivariate analysis showed no difference between placebo and liraglutide arms in HbA1c at six months (HbA1c:0.2 mmol/mol, −11.3, 11.6, p=0.98) however, at 12 months HbA1c was significantly higher in the liraglutide arm (HbA1c:10.9 mmol/mol, 1.1, 20.6, p=0.032). There was no difference between arms in weight at six months (BW:2.0 kg, −4.2, 8.1, p=0.50), however, at 12 months weight was significantly higher in the liraglutide arm (BW:8.2 kg, 1.6, 14.9, p=0.02, Figure 1). There were no significant differences in adverse events between groups.
Comparing the distribution of T2DM duration between groups, those in the liraglutide arm seemed to have longer duration of diabetes. However, objective statistical analysis of the duration of T2DM between groups did not show any significant difference (p=0.23). There was no significant difference between groups in remission of diabetes at six months (L: 9.1%, P: 18.2%, p=1.00) and 12 months (L:27.3%, C:25.0%, p=1.00).
There were 42 adverse events (AE) that occurred during the trial: 32 were in the liraglutide arm and 10 were in the placebo arm. There were three serious adverse events (SAEs) during the trial: 2 in the liraglutide arm and 1 in the placebo arm. The most serious occurred in the placebo arm: cholecystitis requiring cholecystectomy. Four participants (two in each treatment arm) had no reported band adjustments. On average participants had 3 band adjustments during the trial, this number did not significantly differ between groups (L:3.0, P:3.0, p=0.39).
“Further larger randomised controlled trials of longer duration, more intensive LAGB follow-up and with more effective agents (i.e. semaglutide, tirzepatide) are required to confirm whether adjunctive GLP-1 agonist therapy and other gut hormone therapies are beneficial post-metabolic surgery in patients with T2DM,” the study authors concluded.
The findings were reported in the paper, 'Laparoscopic adjustable gastric banding with liraglutide in adults with obesity and type 2 diabetes (GLIDE): a pilot randomised placebo controlled trial', published in International Journal of Obesity. To access this paper, please click here
Commentaires