NCT02891954Active, not recruitingPhase 1
Genetics of Response to Canagliflozin
Pharmacogenomics to Predict Responses to SGLT2 Inhibitors
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
Five daily doses of canagliflozin (300 mg) will be administered to healthy volunteers. Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after administration of the first dose of canagliflozin. A genome-wide association study (GWAS) will be conducted to search for genetic variants that are associated with each of the pharmacodynamic responses to canagliflozin.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 30 Aug 2016
- Start date
- Sept 2016
- Primary completion date
- 25 Sept 2023
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Type 2 diabetes
- NCT number
- NCT02891954
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 700
- From Sept 2016 to the primary completion date, 25 Sept 2023
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking diuretics, antihypertensive medication uric acid lowering medications, or other medication that the investigator judges will make interpretation of the results difficult
- Unwilling to go off of vitamin supplements and over the counter medication (except for acetaminophen) for at least two weeks prior to the first home visit and agree to avoid these medications for the duration of the study.
Other illness
- Known allergy to canagliflozin
- Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or other diseases that the investigator judges will make interpretation of the results difficult or increase the risk of participation
- Seizure disorder
Lab values
- History of diabetes, random glucose greater than 200 mg/dL, or HbA1c greater than or equal to 6.5%
Other
- Positive urine human chorionic gonadotropin test or known pregnancy within 3 months of the start of the study
- Estimated glomerular filtration rate less than 60 mL/min
- Currently breast feeding or breast feeding within 3 month of the start of the study
- Liver function tests greater than 2 times the upper limit of normal
- Hematocrit less than 35%
- Abnormal thyroid hormone stimulating hormone
Who the study is looking for
- Of Amish descent
- Age 18 or older
- BMI: 18-40 kg/m2
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.