Liraglutide in Newly Onset Type 1 Diabetes.

NCT ID: NCT01879917

Last Updated: 2021-03-30

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

PHASE2/PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-08-31

Brief Summary

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The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Liraglutide

1.8 mg

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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Liraglutide

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
* Age 18 - 40 years - both inclusive
* Postprandial C-peptide \> 0.2 nmol/l following sustacal meal test
* Able to understand the written patient information and to give informed consent

Exclusion Criteria

* Type 2 diabetes
* Body mass index \<20 kg/m2
* Pregnancy or unwillingness to use safe contraceptives
* Compromised kidney function (eGFR \< 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
* Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at visit 0
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thomas Dejgaard

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sten Madsbad, Professor

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

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Dep. of Endocrinology, Hvidovre University Hospital

Hvidovre, Capital, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2012-005317-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1137-3221

Identifier Type: OTHER

Identifier Source: secondary_id

2012-005317-39

Identifier Type: -

Identifier Source: org_study_id

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