NCT03845179

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

February 11, 2019

Last Update Submit

March 15, 2021

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • C-peptide

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

    5 hours

Secondary Outcomes (7)

  • Plasma glucose

    5 hours

  • Insulin

    5 hours

  • Total and intact GIP

    5 hours

  • Total and intact GLP-1

    5 hours

  • Glucagon

    5 hours

  • +2 more secondary outcomes

Other Outcomes (3)

  • Gallbladder volume

    5 hours

  • Systolic and diastolic blood pressure

    5 hours

  • heart rate

    5 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: PlaceboOther: GIP receptor antagonistOther: Placebo tablet

DPP-4 inhibitor

ACTIVE COMPARATOR

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

Other: PlaceboOther: GIP receptor antagonistDrug: DPP-4 inhibitor

Interventions

PlaceboOTHER

Saline infusion

DPP-4 inhibitorPlacebo
GIP receptor antagonistOTHER

Used for infusion on study days

DPP-4 inhibitorPlacebo
DPP-4 inhibitorDRUG

Oral administration of DPP-4 inhibitor in active treatment period

Also known as: Sitagliptin
DPP-4 inhibitor
Placebo tabletOTHER

Oral administration of placebo tablet in placebo treatment period

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

Location

Related Publications (1)

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

    PMID: 35796651DERIVED

MeSH Terms

Interventions

Dipeptidyl-Peptidase IV InhibitorsSitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of DrugsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded study. Both participants and investigators are blinded to interventions.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, placebo-controlled, cross-over.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 19, 2019

Study Start

May 29, 2019

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

DK(1)