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 v
Conditions
Sponsors
Department of Endocrinology, Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria: *Type 2 diabetes *Body mass index 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the following parameters from randomisation to the end of treatment: * Maximal postprandial C-peptide concentration following sustacal meal test * Incremental C-peptide response following sustacal meal test * Beta-cell sensitivity to glucose during the sustacal meal test as estimated by use of mathematical modelling * Glucagon response following sustacal meal test * Daily insulin dose * HbA1c * Self-monitored blood glucose (SMBG) profile * Fasting and postprandial lipid profile following sustacal meal test * Weight * Waist circumference * Quality of life;Timepoint(s) of evaluation of this end point: At the end of treatment after 52 weeks of intervention. | — |
Countries
Denmark
Contacts
Public ContactThomas Dejgaard
Coordinating Investigator
Outcome results
None listed