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Clinical Trials/NCT03845179
NCT03845179
Completed
Not Applicable

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

University Hospital, Gentofte, Copenhagen1 site in 1 country12 target enrollmentMay 29, 2019

Overview

Phase
Not Applicable
Intervention
Placebo
Conditions
Type2 Diabetes
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
12
Locations
1
Primary Endpoint
C-peptide
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 29, 2019
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Signe Stensen

MD

University Hospital, Gentofte, Copenhagen

Eligibility Criteria

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

Arms & Interventions

Placebo

Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

Intervention: Placebo

Placebo

Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

Intervention: GIP receptor antagonist

Placebo

Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

Intervention: Placebo tablet

DPP-4 inhibitor

DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

Intervention: Placebo

DPP-4 inhibitor

DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

Intervention: GIP receptor antagonist

DPP-4 inhibitor

DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)

Intervention: DPP-4 inhibitor

Outcomes

Primary Outcomes

C-peptide

Time Frame: 5 hours

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

Secondary Outcomes

  • Total and intact GIP(5 hours)
  • Insulin(5 hours)
  • Total and intact GLP-1(5 hours)
  • CTX(5 hours)
  • Plasma glucose(5 hours)
  • Glucagon(5 hours)
  • Lipids(5 hours)

Study Sites (1)

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