GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake

GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake

The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.

The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.

Inclusion criteria:

• Caucasian men
• Age between 18 and 70 years
• Body mass index (BMI) between 25 and 40 kg/m2
• Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mM (<8.5 %)
• In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
• Informed consent

Exclusion criteria

• Anaemia (haemoglobin outside normal range)
• Any current or prior gastrointestinal disease that may interfere with the endpoint variables
• Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder.
• Nephropathy (serum creatinine above normal range and/or albuminuria).
• Anorexia, bulimia or binge eating disorder
• Allergy or intolerance to ingredients included in the standardised meals
• Tobacco smoking
• Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
• Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
• Any physical or psychological condition that the investigator feels would interfere with trial participation