Incretin-based Therapy in Late Preclinical Type 1 Diabetes

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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; Liraglutide

Criteria

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