Pharmacogenomics to Predict Responses to SGLT2 Inhibitors

NCT02891954 Phase 1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	700
Start date	2016-09
Completion	2026-12-25

Conditions

• Diabetes Mellitus, Type 2

Interventions

• Canagliflozin

Primary outcomes

• Urinary glucose excretion (during the time interval 24-48 hours after first administration of canagliflozin) — 24-48 hours
  Urine collection will be initiated 24 hours after initiation of canagliflozin treatment, and continued for an additional 24 hours.