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Effect of GIP After a Meal in Patients With Type 2 Diabetes (GA-7)

Primary Purpose

Type2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

GIP(3-30)NH2

Peripheral venous cannulation

GLP-1

About this trial

This is an interventional basic science trial for Type2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes
HbA1c < 75 mmol/mol
BMI > 27 kg/m2
Stable weight (+/- 5%) during the last 3 months

Exclusion Criteria:

Treatment with medicine or dietary supplements that cannot the paused for 12 hours
More than 14 units of alcohol weekly or abuse of drugs
Liver disease, estimated at plasma ALAT levels > 3 x normal value or INR outside normal range
Reduced kidney function (estimated at eGFR < 60 ml/min/1,73 m2)
Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)
Low red blood cell count (hemoglobin < 8.3 mmol/l
Special diet or planned weight change during the trial period
Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial

Sites / Locations

Center for Diabetes Research, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

GIP(3-30)NH2

Placebo

GLP-1

GLP-1 + GIP(3-30)NH2

Arm Description

GIP receptor antagonist

Placebo (saline infusions)

Outcomes

Primary Outcome Measures

Glucagon

Plasma levels of glucagon after a meal in patients with type 2-diabetes

Secondary Outcome Measures

Full Information

NCT ID

NCT03702660

First Posted

October 30, 2017

Last Updated

April 23, 2021

Sponsor

University Hospital, Gentofte, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT03702660

Brief Title

Effect of GIP After a Meal in Patients With Type 2 Diabetes

Acronym

GA-7

Official Title

Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

January 23, 2018 (Actual)

Study Completion Date

January 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.

6. Conditions and Keywords

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

Type2 Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GIP(3-30)NH2

Arm Type

Experimental

Arm Description

GIP receptor antagonist

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (saline infusions)

Arm Title

GLP-1

Arm Type

Active Comparator

Arm Title

GLP-1 + GIP(3-30)NH2

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

GIP(3-30)NH2

Intervention Description

Peptide derived from the naturally occuring gut hormone GIP

Intervention Type

Other

Intervention Name(s)

Peripheral venous cannulation

Intervention Description

Intravenous access for infusions

Intervention Type

Other

Intervention Name(s)

GLP-1

Intervention Description

Peptide infusion

Primary Outcome Measure Information:

Title

Glucagon

Description

Plasma levels of glucagon after a meal in patients with type 2-diabetes

Time Frame

8 weeks - 6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes HbA1c < 75 mmol/mol BMI > 27 kg/m2 Stable weight (+/- 5%) during the last 3 months Exclusion Criteria: Treatment with medicine or dietary supplements that cannot the paused for 12 hours More than 14 units of alcohol weekly or abuse of drugs Liver disease, estimated at plasma ALAT levels > 3 x normal value or INR outside normal range Reduced kidney function (estimated at eGFR < 60 ml/min/1,73 m2) Severe arteriosclerotic heart disease or heart failure (NYHA III or IV) Low red blood cell count (hemoglobin < 8.3 mmol/l Special diet or planned weight change during the trial period Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Signe Stensen, MD

Organizational Affiliation

Center for Diabetes Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Diabetes Research, Gentofte Hospital

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of GIP After a Meal in Patients With Type 2 Diabetes

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