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

Primary Purpose

Type 2 Diabetes Mellitus, Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

GIP1-42 infusion

Saline

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Center for diabetes research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GIP infusion

Saline

Arm Description

5 hours of continuously GIP1-42 infusion

5 hours of continuously saline infusion

Outcomes

Primary Outcome Measures

food intake

food intake (kJ) eaten from an ad libitum meal of pasta bolognese

Secondary Outcome Measures

Appetite

Appetite rated on visual analogue scales (0-10 mm)

satiety

Satiety rated on visual analogue scales (0-10 mm)

prospective food consumption

prospective food consumption rated on visual analogue scales (0-10 mm)

fullness

fullness rated on visual analogue scales (0-10 mm)

Thirst

Thirst rated on visual analogue scales (0-10 mm)

Nausea

Nausea rated on visual analogue scales (0-10 mm)

Energy expenditure

resting energy expenditure measured by indirect calorimetry (kcal/day)

gastric emptying

acetaminophen test

gallbladder emptying

gallbladder emptying evaluated by ultrasound

glucagon responses

blood samples

Insulin responses

blood samples

C-peptide responses

blood samples

gut hormone responses

Blood samples

bone turnover markers

Blood samples

Full Information

NCT ID

NCT03526289

First Posted

October 24, 2017

Last Updated

December 4, 2018

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Zealand Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03526289

Brief Title

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

Acronym

GASOLIN II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

October 24, 2018 (Actual)

Study Completion Date

October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Zealand Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Overweight and Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GIP infusion

Arm Type

Active Comparator

Arm Description

5 hours of continuously GIP1-42 infusion

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

5 hours of continuously saline infusion

Intervention Type

Biological

Intervention Name(s)

GIP1-42 infusion

Intervention Description

5-hour GIP1-42 infusion (time point 0-300 minutes)

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

5-hour infusion of saline (placebo) (time point 0-300 minutes)

Primary Outcome Measure Information:

Title

food intake

Description

food intake (kJ) eaten from an ad libitum meal of pasta bolognese

Time Frame

time point 300-330 minutes

Secondary Outcome Measure Information:

Title

Appetite

Description

Appetite rated on visual analogue scales (0-10 mm)

Time Frame