Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.

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

Details

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

Criteria

Inclusion Criteria:

• 10-30 years of age

• early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)

• not pregnant.

Exclusion Criteria:

• allergic to liraglutide or other ingredients of Victoza®

• diabetic ketoacidosis

• previous treatment in the last three months with any antidiabetic medication other than insulin

• 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