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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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