Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

University of Oulu

Status and phase

Invitation-only

Phase 2

Conditions

Type 1 Diabetes

Treatments

Drug: Victoza®

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02611232

U1111-1176-6062 (Other Identifier)

2014-003667-37 (EudraCT Number)

LiraAAB18-30

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

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

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