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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004760-37 | EudraCT Number | ||
| 3-SRA-2014-301-M-R | Other Grant/Funding Number | Juvenile Diabetes Research Foundation International | |
| U1111-1177-0661 | Other Identifier | WHO |
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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
| Skane University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Victoza® (liraglutide) | Active Comparator | 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® |
|
| Placebo | Placebo Comparator | Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Victoza® (liraglutide) | Drug | Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riitta Veijola, MD | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oulu and Oulu University Hospital, Dept of Children and Adolescents | Oulu | 90029 | Finland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35797241 | Derived | Kero J, Koskenniemi JJ, Karsikas S, Pokka T, Lou O, Toppari J, Veijola R. INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Diabet Med. 2022 Oct;39(10):e14913. doi: 10.1111/dme.14913. Epub 2022 Jul 22. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| OTHER |
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| Placebo | Drug | Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months. |
|
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 |
| University of Tampere and Tampere University Hospital |
| Tampere |
| 33520 |
| Finland |
| University of Turku and Turku University Hospital | Turku | 20520 | Finland |
| Lund University and Skåne University Hospital | Malmö | 205 02 | Sweden |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |