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Incretin-based Therapy in Late Preclinical Type 1 Diabetes (NCT02898506)

Tampere University Hospital
Turku University Hospital
Oulu University Hospital
Skåne University Hospital
The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.
  • Drug: Victoza®
    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
    • Drug: Placebo
      Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
      Ages eligible for Study
      10 Years to 30 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • 10-30 years of age
      • positive for at least 2 islet autoantibodies
      • glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT
      • not pregnant
      Exclusion Criteria:
      • allergic to liraglutide or other ingredients of Victoza
      • type 1 diabetes
      • diabetic ketoacidosis
      • previous treatment in the last three months with any antidiabetic medication
      • impaired liver or kidney function or on dialysis
      • severe heart failure
      • severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
      • past or current history of pancreatitis
      • serum calcitonin value above normal (>50 ng/l or at least 3.4pmol/l)
      • presence of any chronic metabolic, hematologic or malignant disease
      • obesity BMI at least 30
      • pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
      • breast-feeding

      4 locations

      Status:
      enrolling by invitation
      Type:
      Interventional
      Phase:
      Start:
      29 February, 2016
      Updated:
      11 September, 2016
      Participants:
      82
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