The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: liraglutide; liraglutide; liraglutide; placebo; placebo; placebo
Intervention description: Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 835.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Europe and North America. The purpose of the trial is to
      investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1
      diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Male or female, aged equal to or greater than 18 years at the time of signing informed
             consent

          -  Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit
             1 (i.e. screening)

          -  Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin
             pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)

          -  Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as
             judged and documented by the investigator

          -  HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both
             inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86
             mmol/mol (International Federation of Clinical Chemistry (IFCC))

        Exclusion Criteria:

          -  Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase
             IV (DPPIV) inhibitors

          -  Use of any medication, which in the investigator's opinion could interfere with the
             glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) 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 (Visit 1) (after resting for 5
             minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for
             diastolic (repeated measurement at Visit 2 (prior to performing the trial related
             activities) is allowed to exclude white-coat hypertension)

          -  History of acute or chronic pancreatitis

          -  Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L