Liraglutide in Newly Onset Type 1 Diabetes.

Diabetes Mellitus, Type 1 Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879917
• Other study ID #: 2012-005317-39
• Secondary ID: 2012-005317-39U1
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2014
• Est. completion date: August 2018

Study information

• Verified date: March 2021
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Liraglutide

• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Dep. of Endocrinology, Hvidovre University Hospital	Hvidovre	Capital

Sponsors (8)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark, Hospital of South West Denmark, Odense University Hospital, Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c	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
Other	Insulin dose	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
Other	Weight	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
Other	Remission period	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
Other	Hypoglycemia	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
Primary	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	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.	52 weeks