The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate

NCT ID: NCT02584582

Last Updated: 2015-10-22

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

Detailed Description

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Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide + Liquid meal test

Liraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

Liquid meal test

Intervention Type PROCEDURE

Exenatide + Liquid meal test

Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

Liquid meal test

Intervention Type PROCEDURE

Baseline + Liquid meal test

Baseline day with no additional medication

Group Type OTHER

Liquid meal test

Intervention Type PROCEDURE

No drug (Baseline day)

Intervention Type OTHER

Interventions

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Liraglutide

Intervention Type DRUG

Exenatide

Intervention Type DRUG

Liquid meal test

Intervention Type PROCEDURE

No drug (Baseline day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 1 Diabetes
* \>18 years
* No residual beta-cell function (stimulated C-peptide \< 60 pmol)

Exclusion Criteria

* Pancreatitis
* gastroparesis
* history of alcohol and/or drug abuse
* pregnancy and lactation
* other medical or psychological condition that made the patient unsuitable for study participation according to the investigators“ assessment
* contraindications to gastroscopy
* cancer (unless in complete remission \> five years)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christan SS Frandsen, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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H-3-2014-128

Identifier Type: -

Identifier Source: org_study_id

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