Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Study Overview
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Brief Summary
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The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.

Official Title
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Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Victoza® (liraglutide)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10-30 years of age early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT) not pregnant. Exclusion Criteria: allergic to liraglutide or other ingredients of Victoza® diabetic ketoacidosis previous treatment in the last three months with any antidiabetic medication other than insulin 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: 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Victoza® (liraglutide)<br>Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza® | Drug: Victoza® (liraglutide)<br>* Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.<br>|
| Placebo Comparator: Placebo<br>Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin 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 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum C-peptide AUC | Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test) | From baseline to 26 and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored | Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period | From baseline to 26 and 52 weeks | 
| Number of hypoglycemia episodes | Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period | From baseline to 26 and 52 weeks | 
| Frequency of gastrointestinal side effects | Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period | 12 months | 
| Insulin dose | Insulin dose IU/kg/day | From baseline to 26 and 52 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, GLP-1 Analogue, Early diagnosis