Diabetes Mellitus, Type 1 MedDRA version: 16.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent obtained - Type 1 diabetes mellitus = 12 months - Male or female, aged 18 – 75 years - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment = 6 months - Stable insulin treatment for the last 3 month prior to Screening, as judged and documented by the investigator - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self-titration of insulin and attend all scheduled visits 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 1300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 104
Exclusion criteria
Exclusion criteria: - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors. - Use of any medication, which in the investigator’s opinion could interfere with the glycaemic control or affect the subject’s safety. Premix insulin is not allowed. - Known proliferative retinopathy or maculopathy requiring acute treatment. - Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator. - Uncontrolled/ untreated blood pressure at screening > 160 mmHg for systolic or >100 mmHg for diastolic. - History of acute or chronic pancreatitis - Screening calcitonin value > 50 ng/L. - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2). - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of liraglutide as adjunct to insulin treatment on glycaemic control, and to confirm the superiority of liraglutide treatment compared to placebo, both adjunct to insulin treatment, with regards to reduction in total daily insulin dose and body weight loss, after 52 weeks of treatment in subjects with established type 1 diabetes with inadequate glycaemic control.;Secondary Objective: To confirm superiority of liraglutide treatment compared to placebo, both adjunct to insulin treatment, in reducing hypoglycaemia during 52 weeks of treatment in subjects with established type 1 diabetes in inadequate glycaemic control. To evaluate safety and tolerability of liraglutide as adjunct to insulin treatment in subjects with type 1 diabetes in inadequate glycaemic control compared to liraglutide placebo as adjunct to insulin treatment.;Primary end point(s): - Change from baseline in HbA1c - Change from baseline in body weight - Change from baseline in total daily insulin dose ;Timepoint(s) of evaluation of this end point: After 52 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of treatment-emergent symptomatic hypoglycaemic episodes ;Timepoint(s) of evaluation of this end point: None | — |
Countries
Argentina, Australia, Belgium, Canada, European Union, Finland, Ireland, Israel, Netherlands, Norway, Poland, Russian Federation, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed