NCT02584582

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

August 6, 2015

Last Update Submit

October 21, 2015

Conditions

Type 1 Diabetes

Keywords

GlucagonGlukagon-like peptide-1 (GLP-1)GLP-1 receptor agonist (GLP-1RA)Incretins

Outcome Measures

Primary Outcomes (1)

  • Glucagon concentration (postprandial)

    glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated

    4 hours

Secondary Outcomes (11)

  • Postprandial glucose concentrations

    4 hours

  • glucagon-like peptide-1 (GLP-1)

    4 hours

  • glucagon-like peptide-2 (GLP-2)

    4 hours

  • glucose-dependent insulinotropic polypeptide (GIP)

    4 hours

  • Cholecystokinin (CCK)

    4 hours

  • +6 more secondary outcomes

Study Arms (3)

Liraglutide + Liquid meal test

EXPERIMENTAL

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)

Drug: LiraglutideProcedure: Liquid meal test

Exenatide + Liquid meal test

EXPERIMENTAL

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

Drug: ExenatideProcedure: Liquid meal test

Baseline + Liquid meal test

OTHER

Baseline day with no additional medication

Procedure: Liquid meal testOther: No drug (Baseline day)

Interventions

LiraglutideDRUG
Liraglutide + Liquid meal test
ExenatideDRUG
Exenatide + Liquid meal test
Liquid meal testPROCEDURE
Baseline + Liquid meal testExenatide + Liquid meal testLiraglutide + Liquid meal test
No drug (Baseline day)OTHER
Baseline + Liquid meal test

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

LiraglutideExenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 6, 2015

First Posted

October 22, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10