Individual albuminuria lowering response to dapagliflozin in a decentralized clinical trial in patients with type 2 diabetes mellitus and elevated albuminuria
- Conditions
- Albuminuria in patients with type 2 diabetes mellitus.100184241001265310029149
- Registration Number
- NL-OMON50915
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
- 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:
o History of active inflammatory bowel disease, within the last six months.
o Major gastrointestinal tract surgery as decided by the treating physician
o Pancreatitis within the last six months.
o Evidence of serious hepatic disease as determined by the treating physician
o 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 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.
- Current pregnancy or breast feeding / attempting to conceive.
- Women of childbearing potential (WOCBP):
o WOCBP 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.
o WOCBP 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study goal is to assess the change in first morning urinary<br /><br>albumin-to-creatinine ratio from start to end of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study goal is to assess changes from baseline in systolic blood<br /><br>pressure, body weight, eGFR and fasting plasma glucose.</p><br>