Liraglutide in Newly Onset Type 1 Diabetes.

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01879917

Acronym

NewLira

Enrollment

Registered

2013-06-18

Start date

2014-02-28

Completion date

2018-08-31

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

c-peptide, insulin, hypoglycemia, Newly onset, Diabetes, Type 1, Beta cell, Autoimmune, Glucagon, Meal test

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.

Interventions

DRUGLiraglutide

DRUGPlacebo

Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Beta-cell function	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.

Secondary

Measure	Time frame	Description
Postprandial glucagon	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.

Other

Measure	Time frame	Description
Weight	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.
HbA1c	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.
Hypoglycemia	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.
Remission period	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.
Insulin dose	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026