Individual urinary protein decreasing effects of dapagliflozin in a remote clinical trial in patients with type 2 diabetes mellitus and elevated urinary protein concentrations.
- Conditions
- Patients with type 2 diabetes and albuminuria >20 mg/g (2.26 mg/mmol)Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2020-004929-23-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- 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) (only when it is known, since the Child-Pugh score is usually not determined in general practice)
- 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:
oHistory of active inflammatory bowel disease, within the last six months.
oMajor gastrointestinal tract surgery as decided by the treating physician.
oPancreatitis within the last six months.
oEvidence of serious hepatic disease as determined by the treating physician.
oEvidence of urinary obstruction or difficulty in voiding at screening.
- Donation or loss of 400 mL of blood within 8 weeks prior to initial dosing
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- (Missing information on) current pregnancy or breast feeding / attempting to conceive.
- Women of childbearing potential (WOCBP):
oWOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.
oWOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) within 0 to 72 hours before the first dose of study drug.
WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below). The following women are WOCBP:
- Women using the following methods to prevent pregnancy: oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
- Women who are practicing abstinence.
- Women who have a partner who is sterile (e.g. due to vasectomy).
Post-menopause is defined as:
- Women who have had amenorrhea for >12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level >35 mIU/mL.
- Women who have irregular menstrual periods and a documented serum FSH level >35 mIU/mL.
-Women who are taking hormone replacement therapy (HRT).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Process: Assessing the feasibility and user-friendliness of remote data collection as well as assessing the experience of patients with remote data collection. <br><br>Clinical trial: <br>Primary: Assessing the change in first morning void urine albumin-to-creatinine ratio from start to end of treatment ;Secondary Objective: Clinical trial:<br>Secondary: Assessing changes from baseline in: <br>- Systolic blood pressure <br>- Body weight and body composition <br>- eGFR <br>- Fasting plasma glucose<br>;Primary end point(s): Process: Feasibility and user-friendliness of remote data collection as well as the experience of patients with remote data collection.<br><br>Clinical trial: Change in first morning void urine albumin-to-creatinine ratio. <br>;Timepoint(s) of evaluation of this end point: Endpoints will be calculated from start to end of treatment (day 0 to day 63 (week 9)).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Changes from baseline in systolic blood pressure, body weight and body composition, eGFR, fasting plasma glucose;Timepoint(s) of evaluation of this end point: Endpoints will be calculated from start to end of treatment (day 0 to day 63 (week 9)).