| Trial ID: | L6799 |
| Source ID: | NCT02908087
|
| Associated Drug: |
Victoza® (Liraglutide)
|
| Title: |
Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Victoza® (liraglutide)|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: University of Oulu | Collaborators: Oulu University Hospital|Tampere University Hospital|Turku University Hospital|Skane University Hospital
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
13
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-03
|
| Completion Date: |
2021-05
|
| Results First Posted: |
|
| Last Update Posted: |
2022-01-11
|
| Locations: |
University of Oulu and Oulu University Hospital, Dept of Children and Adolescents, Oulu, 90029, Finland|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
|
| URL: |
https://clinicaltrials.gov/show/NCT02908087
|
