| Trial ID: | L3570 |
| Source ID: | NCT04234867
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)
|
| Acronym: |
Dapa-Stress
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Diabetic Ketoacidosis
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Placebo oral tablet|OTHER: Stress|OTHER: Placebo Stress
|
| Outcome Measures: |
Primary: time to development of DKA, time from Insulin withdrawal to development of DKA (defined as HCO3 -\< 19mmol/L), 12 hours | Secondary: time to decrease of ph level, time from Insulin withdrawal to decrease of pH \< 7.30, 12 hours
|
| Sponsor/Collaborators: |
Sponsor: Kinderkrankenhaus auf der Bult
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
2
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-18
|
| Completion Date: |
2022-08-26
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-09
|
| Locations: |
Kinder- und Jugendkrankenhaus AUF DER BULT, Hanover, Lower Saxony, 30173, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT04234867
|
