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Completed

NCT Number: NCT03845179

GA 6: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide

This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.

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Key information

Conditions

Type2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

About this study

A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes, treatment: lifestyle changes or metformin
  • HbA1c < 75 mmol/mol

Exclusion criteria

  • diagnosed liver disease
  • eGFR < 60 ml/min/1,73m2
  • NYHA III or IV
  • anemia.

Treatment and study plan

Placebo

Other

Saline infusion

GIP receptor antagonist

Other

Used for infusion on study days

DPP-4 inhibitor

Drug

Oral administration of DPP-4 inhibitor in active treatment period

Other names: Sitagliptin

Placebo tablet

Other

Oral administration of placebo tablet in placebo treatment period

Primary outcomes

  1. C-peptide

    Time frame: 5 hours

    Concentrations of C-peptide during GIP receptor antagonism compared to placebo

Secondary outcomes

  1. Plasma glucose

    Time frame: 5 hours

    Concentrations of plasma glucose during GIP receptor antagonism compared to placebo

  2. Insulin

    Time frame: 5 hours

    Concentrations of insulin during GIP receptor antagonism compared to placebo

  3. Total and intact GIP

    Time frame: 5 hours

    Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo

  4. Total and intact GLP-1

    Time frame: 5 hours

    Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo

  5. Glucagon

    Time frame: 5 hours

    Concentrations of glucagon during GIP receptor antagonism compared to placebo

  6. CTX

    Time frame: 5 hours

    Concentrations of CTX during GIP receptor antagonism compared to placebo

  7. Lipids

    Time frame: 5 hours

    Concentrations of lipids during GIP receptor antagonism compared to placebo

Other outcomes

  1. Gallbladder volume

    Time frame: 5 hours

    Measures from ultrasound sonography

  2. Systolic and diastolic blood pressure

    Time frame: 5 hours

    Repeated measures

  3. heart rate

    Time frame: 5 hours

    Repeated measures

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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