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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity

Treatments: Biological: GIP1-42 infusion; Other: Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03526289

H-16031728

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

GIP infusion

Active Comparator group

Description:

5 hours of continuously GIP1-42 infusion

Treatment:

Biological: GIP1-42 infusion

Saline

Placebo Comparator group

Description:

5 hours of continuously saline infusion

Treatment:

Other: Saline