Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

University of Oulu

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: Placebo; Drug: Victoza® (liraglutide)

Study type: Interventional

Funder types: Other

Identifiers

NCT02908087

LiraT1D10-30

U1111-1177-0661 (Other Identifier)

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

2014-004760-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Victoza® (liraglutide)

Active Comparator group

Description:

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®

Treatment:

Drug: Victoza® (liraglutide)

Placebo

Placebo Comparator group

Description:

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo

Treatment:

Drug: Placebo