Liraglutide in Newly Onset Type 1 Diabetes. (NewLira)

March 28, 2021 updated by: Thomas Dejgaard, Hvidovre University Hospital

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital
      • Hvidovre, Capital, Denmark, 2650
        • Dep. of Endocrinology, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: Placebo
Saline
Active Comparator: Liraglutide
1.8 mg
Drug: Liraglutide
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta-cell function
Time Frame: 52 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucagon
Time Frame: 52 weeks
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in Postprandial glucagon levels following sustacal meal test.
52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 52 weeks
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in: HbA1c.
52 weeks
Insulin dose
Time Frame: 52 weeks
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change ininsulin dose.
52 weeks
Weight
Time Frame: 52 weeks
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in weight.
52 weeks
Remission period
Time Frame: 52 weeks
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in length of insulin remission period.
52 weeks
Hypoglycemia
Time Frame: 52 weeks
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in frequency of hypoglycaemic events.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Odense University Hospital
Aarhus University Hospital
Bispebjerg Hospital
Hillerod Hospital, Denmark
Steno Diabetes Center Copenhagen
Aalborg University Hospital
Hospital of South West Jutland

Investigators

  • Study Director: Sten Madsbad, Professor, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-005317-39 (EudraCT Number)
  • U1111-1137-3221 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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