| Trial ID: | L1674 |
| Source ID: | NCT06374043
|
| Associated Drug: |
Dapagliflozin 10mg Tab
|
| Title: |
Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.
|
| Acronym: |
@HOME
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Diabetes Mellitus Type 2 With Proteinuria|Diabetes Mellitus|Diabetes|Diabetes Complications|Albuminuria|Chronic Kidney Diseases|Chronic Kidney Disease Due to Type 2 Diabetes Mellitus|CKD|Proteinuria
|
| Interventions: |
DRUG: Dapagliflozin 10mg Tab|DRUG: Placebo|DEVICE: Withings BPM Connect|DEVICE: Withings Body+|DIAGNOSTIC_TEST: Hem-Col Capillary Blood Collection Device|DEVICE: MEMS (Medication Electronic Monitoring System) Cap|BEHAVIORAL: Questionnaire: participants' perspectives toward remote data collection
|
| Outcome Measures: |
Primary: UACR response, The individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR), Will be assessed within 6 months and reported within 1.5 years after conclusion of the study. | Secondary: Systolic blood pressure response, The individual response to the SGLT2 inhibitor dapagliflozin in systolic blood pressure., Will be assessed within 6 months and reported within 1.5 years after conclusion of the study.|Body weight response, The individual response to the SGLT2 inhibitor dapagliflozin in body weight., Will be assessed within 6 months and reported within 1.5 years after conclusion of the study.|eGFR response, The individual response to the SGLT2 inhibitor dapagliflozin in eGFR., Will be assessed within 6 months and reported within 1.5 years after conclusion of the study.|Fasting plasma glucose response, The individual response to the SGLT2 inhibitor dapagliflozin in glucose., Will be assessed within 6 months and reported within 2 years after conclusion of the study.
|
| Sponsor/Collaborators: |
Sponsor: University Medical Center Groningen | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-05-11
|
| Completion Date: |
2022-09-13
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-22
|
| Locations: |
Ziekenhuisgroep Twente, Almelo, Netherlands|University Medical Center Groningen, Groningen, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT06374043
|
