Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Collaborators: Oulu University Hospital; Tampere University Hospital; Turku University Hospital
• Treatments: Incretins; Liraglutide

Criteria

Inclusion Criteria:

• 18-30 years of age

• positive for at least 2 biochemical islet autoantibodies

• have normal glucose tolerance in OGTT

• are 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 ≥3.4pmol/l)

• presence of any chronic metabolic, hematologic or malignant disease

• obesity BMI ≥30

• pregnant females and females of childbearing potential who are not using adequate contraceptive methods.

• breast-feeding