Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin.

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.

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

Oral administration

DRUG

Placebo

Oral administration

DEVICE

Withings BPM Connect

CE marked and clinically validated blood pressure monitor. Clinical trial results are within the margin of acceptance defined by the internationally recognized evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 81060-2:2014, developed by the European Society of Hypertension, British Hypertension Society and Association for the Advancement of Medical Instrumentation/American Heart Association. Blood pressure will be measured by the participants once daily on 28 days. Three consecutive measurements are taken.

DEVICE

Withings Body+

CE marked and clinically validated advanced Wi-Fi smart scale. Body weight will be measured by the participants once daily on 40 days.

DIAGNOSTIC_TEST

Hem-Col Capillary Blood Collection Device

Capillary blood samples will be obtained using a BD Microtainer® Contact-Activated Lancet (Franklin Lakes, New Jersey, USA) once daily on 22 days. These blood samples will be collected into Hem-Col® tubes (Hem-Col, Labonovum, Limmen, the Netherlands), specifically designed for collection of capillary blood acquired through a finger prick. The Hem-Col microtube is equipped with an anticoagulant and a preservation buffer, enhancing the stability of analytes in whole blood. These Hem-Col tubes have the dimensions of standard blood collection tubes and are constructed from polyethylene, featuring a pierceable cap made of thermoplastic elastomers. Each tube incorporates a liquid barrier, with the inner part preventing the loss of Hem-Col preservation fluid and the outer part serving as a scoop for collecting blood from a finger prick. The Hem-Col lithium heparin tubes will be utilized for the analysis of creatinine, CRP, lipid profile, HbA1c, uric acid, glucose and NT-proBNP.

DEVICE

MEMS (Medication Electronic Monitoring System) Cap

Medication will be provided in standard medicine bottles with the MEMS® (Medication Electronic Monitoring System) Cap (AARDEX Ltd, Union City, CA, USA), which is a customizable medication package which records and stores up to 4,000 dosing events. The cap fits on standard medicine bottles and with integrated microcircuits, the child-resistant MEMS® Cap records the date and time whenever a patient opens a vial. The stored information can be transferred at any time through the MEMS® Reader to the adherence software for immediate analysis and interpretation.

BEHAVIORAL

Questionnaire: participants' perspectives toward remote data collection

Self-made questionnaires consisting of 6 multiple choice questions and 2 open questions will be used to assess patient experience and satisfaction to guide and inform future trials and use in clinical practice.

Sponsors & Collaborators

• AstraZeneca

  collaborator INDUSTRY

• University Medical Center Groningen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-11

Primary Completion

2022-09-13

Completion

2022-09-13

FDA Drug

Yes

FDA Device

Yes

Countries

• Netherlands

Study Locations