| Trial ID: | L5738 |
| Source ID: | NCT02611232
|
| Associated Drug: |
Victoza®
|
| Title: |
Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Victoza®|DRUG: Placebo
|
| Outcome Measures: |
Primary: FPIR (first phase insulin response), First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test ), From baseline to 26 and 104 weeks | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: University of Oulu | Collaborators: Oulu University Hospital|Tampere University Hospital|Turku University Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2015-12
|
| Completion Date: |
2024-06
|
| Results First Posted: |
|
| Last Update Posted: |
2022-01-25
|
| Locations: |
University of Oulu and Oulu University Hospital, Oulu, 90029, Finland|University of Tampere and Tampere University Hospital, Tampere, 33521, Finland|University of Turku and Turku University Hospital, Turku, 20520, Finland
|
| URL: |
https://clinicaltrials.gov/show/NCT02611232
|
