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

NCT ID: NCT03845179

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2020-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, placebo-controlled, cross-over.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded study. Both participants and investigators are blinded to interventions.

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline infusion

GIP receptor antagonist

Intervention Type OTHER

Used for infusion on study days

Placebo tablet

Intervention Type OTHER

Oral administration of placebo tablet in placebo treatment period

DPP-4 inhibitor

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Saline infusion

GIP receptor antagonist

Intervention Type OTHER

Used for infusion on study days

DPP-4 inhibitor

Intervention Type DRUG

Oral administration of DPP-4 inhibitor in active treatment period

Interventions

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Placebo

Saline infusion

Intervention Type OTHER

GIP receptor antagonist

Used for infusion on study days

Intervention Type OTHER

DPP-4 inhibitor

Oral administration of DPP-4 inhibitor in active treatment period

Intervention Type DRUG

Placebo tablet

Oral administration of placebo tablet in placebo treatment period

Intervention Type OTHER

Other Intervention Names

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Sitagliptin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Signe Stensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Clinical Metabolic Research

Copenhagen, Hellerup, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35796651 (View on PubMed)

Other Identifiers

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H-18040916

Identifier Type: -

Identifier Source: org_study_id

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