Genetics of Response to Canagliflozin
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|ClinicalTrials.gov Identifier: NCT02891954|
Recruitment Status : Enrolling by invitation
First Posted : September 8, 2016
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Canagliflozin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pharmacogenomics to Predict Responses to SGLT2 Inhibitors|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: Single arm
Healthy volunteers will receive canagliflozin to assess pharmacodynamic responses to drug.
Healthy volunteers will receive canagliflozin (300 mg per day) in the morning for five days.
Other Name: Invokana (brand name for canagliflozin)
- Urinary glucose excretion (during the time interval 24-48 hours after first administration of canagliflozin) [ Time Frame: 24-48 hours ]Urine collection will be initiated 24 hours after initiation of canagliflozin treatment, and continued for an additional 24 hours.
- Bone-related biomarkers [ Time Frame: 48 hrs ]Serum phosphorus, FGF23, 1,25-dihydroxyvitamin D, PTH, P1NP, and beta-CTX
- Bone-related biomarkers [ Time Frame: 120 hrs ]Serum phosphorus, FGF23, 1,25-dihydroxyvitamin D, PTH, P1NP, and beta-CTX
- Ketosis-related biomarkers [ Time Frame: 48 hrs ]glucagon, acetoacetate, beta-hydroxybutyrate
- Ketosis-related biomarkers [ Time Frame: 120 hurs ]glucagon, acetoacetate, beta-hydroxybutyrate
- Serum uric acid [ Time Frame: 48 hrs ]Change in serum uric acid at 48 hours
- Serum uric acid [ Time Frame: 120 hrs ]Change in serum uric acid at 120 hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891954
|Principal Investigator:||Simeon I Taylor, MD, PhD||Unversity of Maryland School of Medicine|