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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Other: Placebo; Other: GIP receptor antagonist; Other: Placebo tablet; Drug: DPP-4 inhibitor

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • Center for Clinical Metabolic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)	Other: Placebo; Saline infusion; Other: GIP receptor antagonist; Used for infusion on study days; Other: Placebo tablet; Oral administration of placebo tablet in placebo treatment period
Active Comparator: DPP-4 inhibitor; DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist)	Other: Placebo; Saline infusion; Other: GIP receptor antagonist; Used for infusion on study days; Drug: DPP-4 inhibitor; Oral administration of DPP-4 inhibitor in active treatment period; Other Names: Sitagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-peptide	Concentrations of C-peptide during GIP receptor antagonism compared to placebo	5 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallbladder volume	Measures from ultrasound sonography	5 hours
Systolic and diastolic blood pressure	Repeated measures	5 hours
heart rate	Repeated measures	5 hours

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Publications and helpful links

General Publications

• Stensen S, Gasbjerg LS, Rosenkilde MM, Vilsbøll T, Holst JJ, Hartmann B, Christensen MB, Knop FK. Endogenous Glucose-Dependent Insulinotropic Polypeptide Contributes to Sitagliptin-Mediated Improvement in β-Cell Function in Patients With Type 2 Diabetes. Diabetes. 2022 Oct 1;71(10):2209-2221. doi: 10.2337/db22-0059.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: H-18040916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No