Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

U

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

42 participants in 2 patient groups, including a placebo group

Victoza®
Active Comparator group
Description:
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)
Treatment:
Drug: Victoza®
Placebo
Placebo Comparator group
Description:
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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