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

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Other: Placebo; Other: GIP receptor antagonist; Drug: DPP-4 inhibitor; Other: Placebo tablet

• Registration Number: NCT03845179
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-19
• Study Start: 2019-05-29
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
C-peptide	5 hours	Concentrations of C-peptide during GIP receptor antagonism compared to placebo

Secondary Outcome Measures

Name	Time	Method
Total and intact GIP	5 hours	Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo
Insulin	5 hours	Concentrations of insulin during GIP receptor antagonism compared to placebo
Total and intact GLP-1	5 hours	Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo
CTX	5 hours	Concentrations of CTX during GIP receptor antagonism compared to placebo
Plasma glucose	5 hours	Concentrations of plasma glucose during GIP receptor antagonism compared to placebo
Glucagon	5 hours	Concentrations of glucagon during GIP receptor antagonism compared to placebo
Lipids	5 hours	Concentrations of lipids during GIP receptor antagonism compared to placebo

Trial Locations

Locations (1)

Center for Clinical Metabolic Research; 🇩🇰 Copenhagen, Hellerup, Denmark