NewLira: Liraglutide in Newly Onset Type 1 Diabetes.

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01879917

Collaborator

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

Enrollment

Location

Arms

53.9

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: Liraglutide Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Liraglutide

1.8 mg

Drug: Liraglutide

Other Names:

Victoza

Placebo Comparator: Saline

Drug: Placebo

Saline

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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