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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003667-37 | EudraCT Number | ||
| 3-SRA-2014-301-M-R | Other Grant/Funding Number | Juvenile Diabetes Research Foundation International | |
| U1111-1176-6062 | Other Identifier | WHO |
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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Victoza® | Active Comparator | Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide) |
|
| Placebo | Placebo Comparator | Subjects with preclinical type 1 diabetes aged 18-30 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. Duration of follow-up 24 months. |
|
| 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 |
| 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 |
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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 | Oulu | 90029 | Finland | |||
| University of Tampere and Tampere University Hospital |
| 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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| Placebo | Drug | Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months. |
|
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 |
| Tampere |
| 33521 |
| Finland |
| University of Turku and Turku University Hospital | Turku | 20520 | Finland |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |