Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

University of Oulu42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Victoza®DRUG

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

PlaceboDRUG

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Oulu and Oulu University Hospital

Oulu, Finland

University of Tampere and Tampere University Hospital

Tampere, Finland

University of Turku and Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

FPIR (first phase insulin response)

First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )

Time frame: From baseline to 26 and 104 weeks

Secondary Outcomes

Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia

Time frame: From baseline to 26 and 104 weeks

Tolerability

Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms

Time frame: From baseline to 26 and 104 weeks

Serum C-peptide AUC

Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)

Time frame: From baseline to 26 and 104 weeks

Data from ClinicalTrials.gov

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