Flexpen devices

After 8 weeks on very low-calorie diet, the study participants were randomized into two groups: one receiving the GLP-1RA liraglutide 1.2 mg per day and the other a control group. Liraglutide was administered using FlexPen devices (Victoza, Novo Nordisk A/S, Bagsvaerd, Denmark) as subcutaneous injections in the abdomen or thigh. Dosing was initiated at 0.6 mg per day, increasing after 1 week to 1.2 mg per day. Both groups followed Cambridge Weight Loss Maintenance Program with Cambridge Weight Plan products. It was not possible to obtain or buy placebo Victoza pens from the production company (Novo Nordisk). Conduction of study and data analyses were performed with the investigator blinded for randomization group.
The intervention period ran from October 2011 to June 2013.

All participants self‐administered treatment with once‐daily subcutaneous liraglutide or placebo in FlexPen devices (Novo Nordisk A/S, Bagsværd, Denmark), starting at a dose of 0.6 mg with weekly 0.6‐mg increments to 3.0 mg. This pooled analysis compared data with liraglutide 3.0 mg and placebo only; additional liraglutide doses were investigated in the phase 2 dose‐finding trial (1.2, 1.8 and 2.4 mg) and the SCALE Diabetes trial (1.8 mg), but those doses were not included in this analysis since they are not approved for weight management. Furthermore, for the phase 2 trial, only data up to 1 year were included for liraglutide 3.0 mg and placebo; after that, all liraglutide‐ or placebo‐treated individuals were switched to treatment with liraglutide 2.4 mg and, thereafter, to 3.0 mg.17 Diet and exercise counselling, provided at approximately monthly intervals, was similar across trials.17, 18, 19, 20, 21, 22 Participants were advised (in groups or individually) to follow a reduced‐calorie diet with an energy deficit of ~500 kcal/d below their estimated total energy expenditure, containing a maximum of 30% energy from fat, ~20% from protein and ~50% from carbohydrates. The diet was reinforced by the use of 3‐day food diaries, and pedometers were provided to encourage participants to achieve a recommended minimum of 150 min/wk of physical activity.