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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845179
• Other study ID #: H-18040916
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Type2 Diabetes

Intervention

Other:
• Placebo
Saline infusion
• GIP receptor antagonist
Used for infusion on study days

Drug:
• DPP-4 inhibitor
Oral administration of DPP-4 inhibitor in active treatment period

Other:
• Placebo tablet
Oral administration of placebo tablet in placebo treatment period

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research	Copenhagen	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gallbladder volume	Measures from ultrasound sonography	5 hours
Other	Systolic and diastolic blood pressure	Repeated measures	5 hours
Other	heart rate	Repeated measures	5 hours
Primary	C-peptide	Concentrations of C-peptide during GIP receptor antagonism compared to placebo	5 hours
Secondary	Plasma glucose	Concentrations of plasma glucose during GIP receptor antagonism compared to placebo	5 hours
Secondary	Insulin	Concentrations of insulin during GIP receptor antagonism compared to placebo	5 hours
Secondary	Total and intact GIP	Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo	5 hours
Secondary	Total and intact GLP-1	Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo	5 hours
Secondary	Glucagon	Concentrations of glucagon during GIP receptor antagonism compared to placebo	5 hours
Secondary	CTX	Concentrations of CTX during GIP receptor antagonism compared to placebo	5 hours
Secondary	Lipids	Concentrations of lipids during GIP receptor antagonism compared to placebo	5 hours