| Trial ID: | L6036 |
| Source ID: | NCT02987738
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes
|
| Acronym: |
DapaDream
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type1diabetes
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: Time in Range 70-180%, Collection of clinical data regarding the treatment of two doses of 10mg dapagliflozin as add-on to night and day closed-loop control using the DreaMed Algorithm and the time within glucose range 70-180 mg/dl (3.9-10mmol/l) \[%\], 24 hours | Secondary: urinary glucose excretion, effect on urinary glucose excretion after a treatment with two doses of 10mg dapagliflozin (1x10 mg before bedtime and 1x10mg in the morning) in patients with type 1 diabetes, 24 hours|postprandial insulin need, effect of postprandial insulin need after Treatment with dapagliflozin, 24 hours|ß-hydroxybutyrate, association between Treatment of dapagliflozin and ß-hydroxybutyrate levels, 24 hours|Reduction of Insulin dose, effect of insulin dose reduction during the DreaMed automated insulin delivery 24 hours after two doses of 10mg dapagliflozin in patients with type 1 diabetes, 24 hours
|
| Sponsor/Collaborators: |
Sponsor: Kinderkrankenhaus auf der Bult | Collaborators: AstraZeneca|Alcedis GmbH
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-02-09
|
| Completion Date: |
2017-12-19
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-15
|
| Locations: |
Kinder - und Jugendkrankenhaus AUF DER BULT, Hannover, 30173, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02987738
|
