NCT01879917

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

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

June 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

4.5 years

First QC Date

June 14, 2013

Last Update Submit

March 28, 2021

Conditions

Diabetes Mellitus, Type 1

Keywords

c-peptideinsulinhypoglycemiaNewly onsetDiabetesType 1Beta cellAutoimmuneGlucagonMeal test

Outcome Measures

Primary Outcomes (1)

  • Beta-cell function

    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.

    52 weeks

Secondary Outcomes (1)

  • Postprandial glucagon

    52 weeks

Other Outcomes (5)

  • HbA1c

    52 weeks

  • Insulin dose

    52 weeks

  • Weight

    52 weeks

  • +2 more other outcomes

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

1.8 mg

Drug: Liraglutide

Saline

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LiraglutideDRUG
Also known as: Victoza
Liraglutide
PlaceboDRUG

Saline

Saline

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Endocrinology, Hvidovre University Hospital

Hvidovre, Capital, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin ResistanceHypoglycemiaDiabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Sten Madsbad, Professor

    Hvidovre University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 18, 2013

Study Start

February 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

DK(1)