iraglutide in type 1 diabetes - A randomised, double-blind, placebo-controlled, parallel group, multi-centre trial of 242 liraglutide treatment in subjects with newly-diagnosed type 1 diabetes (The NewLira Study)

Phase 1

Conditions: The effect 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.Also to investigate the effect on postprandial glucagon levels following sustacal meal test, HbA1c, insulin dose, self-monitored blood glucose profile,frequency of hypoglycaemic events, fasting and postprandial cholesterol profile, weight, waist circumference and quality of life. .
MedDRA version: 16.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-005317-39-DK

Lead Sponsor: Department of Endocrinology, Hvidovre Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

*Type 2 diabetes
*Body mass index <20 kg/m2 at Visit 0
*Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
*Pregnant or nursing women
*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
*Cancer unless in complete remission for > 5 years
*Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics which in the Investigator’s opinion could interfere with glucose metabolism
*Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 3 months
*Inflammatory bowel disease
*Calcitonin = 50 ng/l at visit 0
*Hypoglycaemia unawareness (unability to register low blood glucose)
*Acute or chronic pancreatitis
*History of thyroid adenoma or carcinoma
*Known or suspected hypersensitivity to trial product or related products
*Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
*Receipt of an investigational drug within 30 days prior to visit 0
*Simultaneous participation in any other clinical intervention trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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, HbA1c, insulin dose, self-monitored blood glucose profile, fasting and postprandial cholesterol profile, weight, waist circumference and quality of life. <br>Other secondary objectives are to investigate the treatment effect on length of insulin remission period and frequency of hypoglycaemic events.;Primary end point(s): Change in area under the C-peptide curve to a sustacal meal from randomisation to the end of treatment.;Timepoint(s) of evaluation of this end point: At the end of treatment after 52 weeks of intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in the following parameters from randomisation to the end of treatment: <br><br>* Maximal postprandial C-peptide concentration following sustacal meal test<br>* Incremental C-peptide response following sustacal meal test <br>* Beta-cell sensitivity to glucose during the sustacal meal test as estimated by use of mathematical modelling<br>* Glucagon response following sustacal meal test<br>* Daily insulin dose<br>* HbA1c<br>* Self-monitored blood glucose (SMBG) profile<br>* Fasting and postprandial lipid profile following sustacal meal test <br>* Weight <br>* Waist circumference <br>* Quality of life;Timepoint(s) of evaluation of this end point: At the end of treatment after 52 weeks of intervention.