Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Victoza®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Victoza®<br>Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide) | Drug: Victoza®<br>* Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.<br>|
| Placebo Comparator: Placebo<br>Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo | Drug: Placebo<br>* Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPIR (first phase insulin response) | First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test ) | From baseline to 26 and 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia | Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia | From baseline to 26 and 104 weeks | 
| Tolerability | Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms | 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) | From baseline to 26 and 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue