A randomised, double-blind, placebo-controlled study to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on the release of gastrointestinal peptides, glycaemic control, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with sitagliptin.

INTERVENTION: Each subject will undergo 2 study days, in double‐blinded, randomised fashion, separated by 3 days. Three days prior to the first study day, subjects will cease their usual oral hypoglycaemic agent and commence sitagliptin oral tablet 100 mg each morning (ie. for three full days prior to the first study day). Subjects will remain on sitagliptin 100 mg daily until the second study day is completed, after which they will revert to their usual therapy (ie. they will receive a total of 7 days of sitagliptin). On each study day, subjects will take their daily dose of sitagliptin oral tablet 100 mg. 60 min later they will be given a test meal ("breakfast") containing 5g of either enterically coated pellets containing lauric acid ("CTM#3") and paracetamol (as a maker of lauric acid release) or placebo pellets. A second identical test meal (“lunch”) will be consumed 4 hours after breakfast, and will again contain 5g of either CTM#3 or placebo pellets , and also 100 mg 13C‐octanoic acid, as a marker of gastric emptying. Those who receive CTM#3 at breakfast will also receive it at lunch, and the same for placebo. CONDITION: Type 2 diabetes mellitus PRIMARY OUTCOME: Blood glucose concentrations SECONDARY OUTCOME: Gastric emptying calculated from breath samples Insulin, glucagon‐like peptide 1 (GLP‐1), peptide YY (PYY), and glucagon plasma concentrations Plasma paracetamol concentrations Sensations of appetite evaluated using a visual analogue questionnaire INCLUSION CRITERIA: Type 2 diabetes, treated by diet alone or single oral hypoglycaemic agent; Body mass index (BMI) 25 ‐ 35 kg/m2; glycated haemoglobin (HbA1c) 7.5% ‐ 9.0%.