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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004761-25 | EudraCT Number | ||
| U1111-1177-0704 | Other Identifier | WHO | |
| 3-SRA-2014-301-M-R | Other Grant/Funding Number | Juvenile Diabetes Research Foundation International |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Active Comparator | Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza® |
|
| Placebo | Placebo Comparator | Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Victoza® | Drug | 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. |
|
| 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 |
| 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 |
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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 |
| 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 and thereafter follow-up of 6 months. |
|
| 12 months |
| Serum C-peptide AUC | Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test) | 12 months |
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |