| Trial ID: | L4390 |
| Source ID: | NCT02325206
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Phase 1 Study to Explore the Safety and Pharmacokinetics of DAPAglifozin in Adolescents and Adults With Type 1 Diabetes
|
| Acronym: |
DAPA-IIT1
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: dapagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: reduction of intravenous insulin dose, reduction of intravenous insulin dose with glucose kept between 160 - 240 mg/dl 24 hours after oral administration of 10mg dapagliflozin, 24hours | Secondary: HbA1c effect, effect of baseline HbA1c on insulin-dose lowering effect of 10mg dapagliflozin, 24hours|urinary glucose excretion, increase of urinary glucose excretion with blood glucose kept between 160 - 220 mg/dl 24 hours after oral administration of 10mg dapagliflozin, 24hours
|
| Sponsor/Collaborators: |
Sponsor: Kinderkrankenhaus auf der Bult
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-12
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-02-19
|
| Locations: |
Kinder - und Jugendkrankenhaus AUF DER BULT, Hannover, 30173, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02325206
|
