Incretin-based Therapy in Late Preclinical Type 1 Diabetes

Study Overview
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Brief Summary
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The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.

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

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: 10-30 years of age positive for at least 2 islet autoantibodies glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT 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 at least 3.4pmol/l) presence of any chronic metabolic, hematologic or malignant disease obesity BMI at least 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: 10 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: Liraglutide<br>Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza® | Drug: Victoza®<br>* Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.<br>|
| Placebo Comparator: Placebo<br>Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 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 and thereafter follow-up of 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPIR (1+3min serum insulin level after iv glucose infusion) | First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test) | 12 months | 

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 | 12 months | 
| Tolerability | Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular | 12 months | 
| Serum C-peptide AUC | Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test) | 12 months | 

 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, Dysglycemia, Prevention