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NCT06374043: @HOME
Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.
Phase 4 trial testing Dapagliflozin 10mg Tab in Diabetes Mellitus, Type 2 in 20 participants. Completed in 13 September 2022.
13 September 2022
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 11 May 2021 |
| Primary completion | 13 September 2022 |
| Estimated completion | 13 September 2022 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- Dapagliflozin 10mg Tab — full drug profile →
- Placebo
- Withings BPM Connect
- Withings Body+
- Hem-Col Capillary Blood Collection Device
- MEMS (Medication Electronic Monitoring System) Cap
- Questionnaire: participants' perspectives toward remote data collection
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Diabetes Mellitus Type 2 With Proteinuria — all drugs for Diabetes Mellitus Type 2 With Proteinuria →
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Diabetes — all drugs for Diabetes →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 With Proteinuria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare. The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose. Participants will collect all study data in the comfort of their own environments: * First-morning void urine samples * Capillary blood samples * Blood pressure * Body weight Participants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06374043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
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- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other University Medical Center Groningen trials
Trials by the same sponsor.
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- NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06374043 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
- Last refreshed: 22 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06374043.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing