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Liraglutide in Newly Onset Type 1 Diabetes. (NewLira)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Liraglutide
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring c-peptide, insulin, hypoglycemia, Newly onset, Diabetes, Type 1, Beta cell, Autoimmune, Glucagon, Meal test

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of Endocrinology, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Liraglutide

Saline

Arm Description

1.8 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postprandial glucagon
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.

Full Information

First Posted
June 14, 2013
Last Updated
March 28, 2021
Sponsor
Hvidovre University Hospital
Collaborators
Steno Diabetes Center Copenhagen, Hillerod Hospital, Denmark, Bispebjerg Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Hospital of South West Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT01879917
Brief Title
Liraglutide in Newly Onset Type 1 Diabetes.
Acronym
NewLira
Official Title
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Steno Diabetes Center Copenhagen, Hillerod Hospital, Denmark, Bispebjerg Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Hospital of South West Jutland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
c-peptide, insulin, hypoglycemia, Newly onset, Diabetes, Type 1, Beta cell, Autoimmune, Glucagon, Meal test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Active Comparator
Arm Description
1.8 mg
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Beta-cell function
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Postprandial glucagon
Description
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.
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
HbA1c
Description
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in: HbA1c.
Time Frame
52 weeks
Title
Insulin dose
Description
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change ininsulin dose.
Time Frame
52 weeks
Title
Weight
Description
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in weight.
Time Frame
52 weeks
Title
Remission period
Description
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.
Time Frame
52 weeks
Title
Hypoglycemia
Description
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.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sten Madsbad, Professor
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Endocrinology, Hvidovre University Hospital
City
Hvidovre
State/Province
Capital
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Liraglutide in Newly Onset Type 1 Diabetes.

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