Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02611232
• Date of registration: 18/11/2015
• Prospective Registration: Yes
• Primary sponsor: University of Oulu
• Public title: Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
• Scientific title: Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
• Date of first enrolment: December 2015
• Target sample size: 42
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT02611232
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Finland

Contacts

• Name: Riitta Veijola, MD
• Affiliation: University of Oulu

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Drug: Placebo

Drug: Victoza®

Primary Outcome(s)

FPIR (first phase insulin response) [Time Frame: From baseline to 26 and 104 weeks]

Secondary Outcome(s)

Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia [Time Frame: From baseline to 26 and 104 weeks]

Serum C-peptide AUC [Time Frame: From baseline to 26 and 104 weeks]

Tolerability [Time Frame: From baseline to 26 and 104 weeks]

Secondary ID(s)

2014-003667-37

3-SRA-2014-301-M-R

LiraAAB18-30

U1111-1176-6062

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Turku University Hospital

Oulu University Hospital

Tampere University Hospital