The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: liraglutide; placebo; liraglutide; placebo; liraglutide; placebo
Intervention description: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 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: 1398.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety
      of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total
      trial duration per subject is approximately 58 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Informed consent obtained

          -  - Type 1 diabetes mellitus for 12 months or longer

          -  - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump)
             treatment for 6 months or longer

          -  - Stable insulin treatment for the last 3 months 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

        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 above 160 mmHg for systolic or
             above 100 mmHg for diastolic

          -  - History of acute or chronic pancreatitis

          -  - Screening calcitonin value equal to or above 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)