Pilot study to test the safety, tolerability and feasibility of dulaglutide during a low-energy diet for weight loss and improved glycaemic control

Abstract

IntroductionDiabetes and obesity are significant public health concerns. Previous studies have demonstrated that low energy diets are effective in promoting weight loss and inducing diabetes remission. However, hunger is a potential barrier to adherence for such diets.Dulaglutide is a glucagon-like peptide receptor agonist used in diabetes treatment. Its use is associated with weight loss, partly through increased satiety. The use of dulaglutide may improve adherence to a low energy diet through a reduction in hunger. We undertook a pilot study to assess the safety, tolerability and feasibility of this combination in individuals with obesity and type 2 diabetes.Research design and methodsWe enrolled individuals with type 2 diabetes and obesity from a tertiary diabetes service in Auckland, New Zealand. Owing to their higher rates of diabetes and poorer diabetes-related health outcomes, we preferentially enrolled Māori and Pacific individuals.Participants underwent 2 weeks of dulaglutide run-in followed by 12 weeks of the combination of dulaglutide and low energy diet. The primary endpoints were the proportion of people successfully completing the dietary intervention and the rates and types of adverse events. Secondary outcomes were changes in weight, glycaemic control, quality of life and biochemical parameters.ResultsThe intervention was well tolerated. Mild side effects were common during the first 2 weeks of the intervention but generally improved over the study period. Eighty-nine per cent of participants completed the 12-week dietary intervention. Participants achieved an average weight loss of 9.5 kg and a mean reduction in haemoglobin A1cof 15.8 mmol/mol. Quality of life metrics were unchanged.ConclusionsWe conclude that the combination of dulaglutide and a low energy diet is a feasible and well-tolerated intervention for individuals with diabetes and increased body weight. Future studies could be performed assessing this combination against a low energy diet alone.Trial registration numberThis study was registered with the Australia New Zealand Clinical Trials Registry (ACTRN1262200015279p).