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Genetics of Response to Canagliflozin Phase 1 700

Active, not recruiting
Clinical Trial NCT02891954 is designed to study Basic Science for Diabetes Mellitus, Type 2. It is a Phase 1 interventional study that is active, not recruiting, having started on September 1, 2016, with plans to enroll 700 participants. Led by University of Maryland, Baltimore, it is expected to complete by December 25, 2026. The latest data from ClinicalTrials.gov was last updated on December 18, 2025.
Brief Summary
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.
Detailed Description
After obtaining informed consent, healthy Amish research subjects will be screened for eligibility. Immediately after obtaining blood samples for baseline clinical chemistry tests wills, patients will initiate 5 days of canagliflozin (300 mg) treatment. Fasting blood samples will be obtained to assess pharmacodynamic responses at both 48 hours and 120 hours after initiating canagliflozin. The principal pharmacodynami...Show More
Official Title

Pharmacogenomics to Predict Responses to SGLT2 Inhibitors

Conditions
Diabetes Mellitus, Type 2
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT02891954
Start Date (Actual)
2016-09
Last Update Posted
2025-12-18
Completion Date (Estimated)
2026-12-25
Enrollment (Estimated)
700
Study Type
Interventional
PHASE
Phase 1
Status
Active, not recruiting
Keywords
Glucosuria
SGLT2 inhibitors
Canagliflozin
FGF23
Parathyroid hormone
1,25-Dihydroxyvitamin D
Glucagon
Ketone bodies
Uric acid
Pharmacogenomics
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSingle arm
Healthy volunteers will receive canagliflozin to assess pharmacodynamic responses to drug.
Canagliflozin
Healthy volunteers will receive canagliflozin (300 mg per day) in the morning for five days.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Urinary glucose excretion (during the time interval 24-48 hours after first administration of canagliflozin)
Urine collection will be initiated 24 hours after initiation of canagliflozin treatment, and continued for an additional 24 hours.
24-48 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Bone-related biomarkers
Serum phosphorus, FGF23, 1,25-dihydroxyvitamin D, PTH, P1NP, and beta-CTX
48 hrs
Bone-related biomarkers
Serum phosphorus, FGF23, 1,25-dihydroxyvitamin D, PTH, P1NP, and beta-CTX
120 hrs
Ketosis-related biomarkers
glucagon, acetoacetate, beta-hydroxybutyrate
48 hrs
Ketosis-related biomarkers
glucagon, acetoacetate, beta-hydroxybutyrate
120 hurs
Serum uric acid
Change in serum uric acid at 48 hours
48 hrs
Serum uric acid
Change in serum uric acid at 120 hours
120 hrs
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Of Amish descent
  • Age 18 or older
  • BMI: 18-40 kg/m2

  • Known allergy to canagliflozin
  • History of diabetes, random glucose greater than 200 mg/dL, or HbA1c greater than or equal to 6.5%
  • Currently taking diuretics, antihypertensive medication uric acid lowering medications, or other medication that the investigator judges will make interpretation of the results difficult
  • 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
  • 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.
  • 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
University of Maryland, Baltimore logoUniversity of Maryland, Baltimore199 active studies to explore
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) logoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Responsible Party
Simeon I. Taylor, Principal Investigator, Professor of Medicine, University of Maryland, Baltimore
No contact data.
No location data.