Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapaglifl… (NCT06374043) | Clinical Trial Compass
CompletedPhase 4
Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.
Netherlands20 participantsStarted 2021-05-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of type 2 diabetes mellitus
* Urinary albumin-to-creatinine ratio \>20 mg/g (2.26 mg/mmol)
* eGFR \>30 ml/min/1.73m2
* Willing to sign informed consent
Exclusion Criteria:
* Diagnosis of type 1 diabetes
* Prior treatment with SGLT2 inhibitor in the four weeks prior to randomization
* History of severe hypersensitivity or contraindications to dapagliflozin
* Unable to monitor blood pressure / body weight or handle digital technologies
* History of non-adherence to medical regimens or unwillingness to comply with the study protocol
* Participation in any clinical investigation within 3 months prior to initial dosing
* Unstable or rapidly progressing renal disease
* Severe hepatic impairment (Child-Pugh class C) as determined by the treating physician.
* Active malignancy
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease, within the last six months; Major gastrointestinal tract surgery as decided by the treating physician; Pancreatitis within the last six months; Evidence of serious hepatic disease as determined by the treating physician; Evidence of urinary obstruction or difficulty in voiding at screening.
* Confirmed lactose intolerance demonstrated with a lactose intolerance test.
* Donation or loss of 400 mL of blood within 8 week…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
UACR response
Timeframe: Will be assessed within 6 months and reported within 1.5 years after conclusion of the study.