Incretin-based Therapy in Late Preclinical Type 1 Diabetes

University of Oulu

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: Placebo; Drug: Victoza®

Study type: Interventional

Funder types: Other

Identifiers

NCT02898506

2014-004761-25 (EudraCT Number)

U1111-1177-0704 (Other Identifier)

3-SRA-2014-301-M-R (Other Grant/Funding Number)

LiraAABDG10-30

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Liraglutide

Active Comparator group

Description:

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®

Treatment:

Drug: Victoza®

Placebo

Placebo Comparator group

Description:

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo

Treatment:

Drug: Placebo