Trial Outcomes & Findings for Pharmacogenetics of SGLT2 Inhibitors (NCT NCT02462421)

NCT ID: NCT02462421

Last Updated: 2022-08-02

Results Overview

The pharmacodynamic response to canagliflozin will be assessed by measuring the increase in 24 hour urinary glucose excretion.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 24 hours after administration of canagliflozin
• Results posted on: 2022-08-02

Participant Flow

We over-estimated the percentage of people who would agree to participate in this clinical trial. Ultimately, we terminated the study after 30 participants had completed the clinical trial.

Participant milestones

Measure	Wild Type Genotype Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.
Overall Study STARTED	13	4	6	7
Overall Study COMPLETED	13	4	6	7
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenetics of SGLT2 Inhibitors

Baseline characteristics by cohort

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total n=30 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	58.6 Years n=5 Participants	57.5 Years n=7 Participants	58.2 Years n=5 Participants	56.1 Years n=4 Participants	57.8 Years n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	13 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
BMI	28.4 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants	30.1 kg/m^2 STANDARD_DEVIATION 3.5 • n=7 Participants	28.2 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants	25.7 kg/m^2 STANDARD_DEVIATION 3.2 • n=4 Participants	28.0 kg/m^2 STANDARD_DEVIATION 4.8 • n=21 Participants
Serum creatinine	0.72 mg/dL STANDARD_DEVIATION 0.15 • n=5 Participants	0.79 mg/dL STANDARD_DEVIATION 0.08 • n=7 Participants	0.74 mg/dL STANDARD_DEVIATION 0.13 • n=5 Participants	0.75 mg/dL STANDARD_DEVIATION 0.11 • n=4 Participants	0.74 mg/dL STANDARD_DEVIATION 0.12 • n=21 Participants
eGFR	95.3 mL/min/1.73m^2 STANDARD_DEVIATION 14.6 • n=5 Participants	96.5 mL/min/1.73m^2 STANDARD_DEVIATION 8.3 • n=7 Participants	96.0 mL/min/1.73m^2 STANDARD_DEVIATION 14.3 • n=5 Participants	98.0 mL/min/1.73m^2 STANDARD_DEVIATION 17.1 • n=4 Participants	96.4 mL/min/1.73m^2 STANDARD_DEVIATION 13.9 • n=21 Participants
Serum sodium	138.8 mEq/L STANDARD_DEVIATION 1.3 • n=5 Participants	138.0 mEq/L STANDARD_DEVIATION 1.8 • n=7 Participants	138.7 mEq/L STANDARD_DEVIATION 1.2 • n=5 Participants	137.6 mEq/L STANDARD_DEVIATION 1.5 • n=4 Participants	138.4 mEq/L STANDARD_DEVIATION 1.4 • n=21 Participants
HbA1c	5.8 % of total hemoglobin that is glycated STANDARD_DEVIATION 0.2 • n=5 Participants	5.7 % of total hemoglobin that is glycated STANDARD_DEVIATION 0.2 • n=7 Participants	5.8 % of total hemoglobin that is glycated STANDARD_DEVIATION 0.2 • n=5 Participants	5.5 % of total hemoglobin that is glycated STANDARD_DEVIATION 0.4 • n=4 Participants	5.7 % of total hemoglobin that is glycated STANDARD_DEVIATION 0.3 • n=21 Participants
Hematocrit	41.8 % STANDARD_DEVIATION 2.4 • n=5 Participants	43.8 % STANDARD_DEVIATION 4.5 • n=7 Participants	39.9 % STANDARD_DEVIATION 4.3 • n=5 Participants	43.3 % STANDARD_DEVIATION 3.1 • n=4 Participants	42.0 % STANDARD_DEVIATION 3.3 • n=21 Participants
Serum uric acid level	4.60 mg/dL STANDARD_DEVIATION 0.72 • n=5 Participants	5.25 mg/dL STANDARD_DEVIATION 0.55 • n=7 Participants	4.05 mg/dL STANDARD_DEVIATION 1.53 • n=5 Participants	3.74 mg/dL STANDARD_DEVIATION 0.71 • n=4 Participants	4.38 mg/dL STANDARD_DEVIATION 0.93 • n=21 Participants
creatinine clearance	110 mL/min/1.73m^2 STANDARD_DEVIATION 29 • n=5 Participants	118 mL/min/1.73m^2 STANDARD_DEVIATION 31 • n=7 Participants	103 mL/min/1.73m^2 STANDARD_DEVIATION 18 • n=5 Participants	126 mL/min/1.73m^2 STANDARD_DEVIATION 37 • n=4 Participants	113 mL/min/1.73m^2 STANDARD_DEVIATION 30 • n=21 Participants
Fractional excretion of uric acid	8.0 % of filtered uric acid that is excreted STANDARD_DEVIATION 1.3 • n=5 Participants	9.4 % of filtered uric acid that is excreted STANDARD_DEVIATION 3.7 • n=7 Participants	6.2 % of filtered uric acid that is excreted STANDARD_DEVIATION 1.5 • n=5 Participants	9.8 % of filtered uric acid that is excreted STANDARD_DEVIATION 2.9 • n=4 Participants	8.5 % of filtered uric acid that is excreted STANDARD_DEVIATION 2.4 • n=21 Participants
Urinary sodium excretion (24 hr)	196 mEq/day STANDARD_DEVIATION 50 • n=5 Participants	182 mEq/day STANDARD_DEVIATION 38 • n=7 Participants	208 mEq/day STANDARD_DEVIATION 105 • n=5 Participants	247 mEq/day STANDARD_DEVIATION 68 • n=4 Participants	208 mEq/day STANDARD_DEVIATION 67 • n=21 Participants

PRIMARY outcome

Timeframe: 24 hours after administration of canagliflozin

Population: The entire population of 30 research participants comprised the database for this analysis.

The pharmacodynamic response to canagliflozin will be assessed by measuring the increase in 24 hour urinary glucose excretion.

Outcome measures

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total Population n=30 Participants Aggregate of all research participants in the four genotypes comprising the four arms of the study.
Urinary Excretion of Glucose (Measured During the 24 Hours Following Administration of Canagliflozin)	37.6 glucose (g)/creatinine (g) Standard Error 2.1	37.1 glucose (g)/creatinine (g) Standard Error 3.3	39.1 glucose (g)/creatinine (g) Standard Error 2.5	36.9 glucose (g)/creatinine (g) Standard Error 2.7	37.7 glucose (g)/creatinine (g) Standard Error 1.2

PRIMARY outcome

Timeframe: 24 hour urine collection after administration of canagliflozin

Population: Data from all 30 patients are summarized. The primary statistical analysis is based on comparison of the 13 "wild type" genotype versus the 7 patients who are homozygous for the variant in SLC2A9 (GLUT9).

For the study arm focused on individuals with a genetic variant in SLC2A9, the pharmacodynamic response to canagliflozin will be assessed by measuring the absolute change in fractional excretion of uric acid in the urine. Fractional excretion of uric acid represents the fraction of the calculated filtered uric acid load (serum uric acid level multiplied by the measured creatinine clearance rate) that was excreted in the urine.

Outcome measures

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total Population n=30 Participants Aggregate of all research participants in the four genotypes comprising the four arms of the study.
Change in Fractional Excretion of Uric Acid (the Difference Between Data After Administration of Canagliflozin Minus Data Before Administration of Canagliflozin)	0.25 absolute change in fractional excretion Standard Error 0.02	0.25 absolute change in fractional excretion Standard Error 0.02	0.28 absolute change in fractional excretion Standard Error 0.04	0.38 absolute change in fractional excretion Standard Error 0.05	0.29 absolute change in fractional excretion Standard Error 0.02

SECONDARY outcome

Timeframe: 24 hours after administration of canagliflozin

The pharmacodynamic response to canagliflozin will be assessed by measuring the % increase in 24 hour urinary excretion of sodium.

Outcome measures

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total Population n=30 Participants Aggregate of all research participants in the four genotypes comprising the four arms of the study.
Canagliflozin-induced Change in Urinary Excretion of Sodium	20 % increase in urinary Na excretion Standard Error 12	66 % increase in urinary Na excretion Standard Error 17	18 % increase in urinary Na excretion Standard Error 10	48 % increase in urinary Na excretion Standard Error 41	32 % increase in urinary Na excretion Standard Error 11

SECONDARY outcome

Timeframe: 24 hours after administration of canagliflozin

The pharmacodynamic response to canagliflozin will be assessed by measuring changes in serum creatinine

Outcome measures

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total Population n=30 Participants Aggregate of all research participants in the four genotypes comprising the four arms of the study.
Canagliflozin-induced Change in Serum Creatinine	0.06 mg/dL Standard Error 0.02	-0.03 mg/dL Standard Error 0.02	0.07 mg/dL Standard Error 0.02	0.05 mg/dL Standard Error 0.02	0.04 mg/dL Standard Error 0.01

SECONDARY outcome

Timeframe: 24 hours after administration of canagliflozin

Population: Data from all 30 research participants will be summarized. Statistical analysis will focus on comparisons between the 13 participants who are homozygous for the major alleles at all three loci versus the three groups who are homozygous for each of the three other genetic variants.

The pharmacodynamic response to canagliflozin will be assessed by measuring changes in serum uric acid level

Outcome measures

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total Population n=30 Participants Aggregate of all research participants in the four genotypes comprising the four arms of the study.
Canagliflozin-induced Change in Serum Uric Acid	-22 % change in serum uric acid level Standard Error 1.9	-29 % change in serum uric acid level Standard Error 4.2	-12 % change in serum uric acid level Standard Error 2.6	-17 % change in serum uric acid level Standard Error 3.0	-20 % change in serum uric acid level Standard Error 1.6

SECONDARY outcome

Timeframe: 24 hrs

The magnitude of the change in fasting plasma glucose 24 hours after administration of canagliflozin (300 mg)

Outcome measures

Measure	Wild Type Genotype n=13 Participants Research subjects with wild type genotypes at three candidate genes encoding sodium-dependent glucose transporter-3, sodium-dependent glucose transporter-4, and glucose transporter-9 (abbreviated as SLC5A4, SLC5A9, SLC2A9, respectively) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A4 n=4 Participants Research subjects who are homozygous for nonsense mutation in SLC5A4 (sodium-dependent glucose transporter-3) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Nonsense Mutation in SLC5A9 n=6 Participants Research subjects who are homozygous for nonsense mutation in SLC5A9 (sodium-dependent glucose transporter-4) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Missense Variant in SLC2A9 n=7 Participants Research subjects who are homozygous for nonsynonymous variant in glucose transporter-9 (SLC2A9) will be studied before and after canagliflozin treatment. Canagliflozin: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.	Total Population n=30 Participants Aggregate of all research participants in the four genotypes comprising the four arms of the study.
Canagliflozin-induced Change in Fasting Plasma Glucose	-5.0 mg/dL Standard Error 1.5	-2.0 mg/dL Standard Error 1.6	-4.7 mg/dL Standard Error 2.8	-3.4 mg/dL Standard Error 1.0	-4.2 mg/dL Standard Error 0.9

Adverse Events

Total Population of Participants in the Clinical Trial

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Total Population of Participants in the Clinical Trial n=30 participants at risk All individuals received the same intervention. With such a small trial and so few adverse events, it is not meaningful to report adverse events for each arm separately. Adverse events were not collected or analyzed according to genotype status.
Musculoskeletal and connective tissue disorders Accident while driving a horse-drawn buggy	3.3% 1/30 • Number of events 1 • Participants received a single dose of canagliflozin (300 mg). The primary assessment of adverse events was during the 48 hours in which people were actively participating in the clinical trial (encompassing the two 24-hour urine collections).
Gastrointestinal disorders Loose stools	3.3% 1/30 • Number of events 1 • Participants received a single dose of canagliflozin (300 mg). The primary assessment of adverse events was during the 48 hours in which people were actively participating in the clinical trial (encompassing the two 24-hour urine collections).

Additional Information

Dr. Simeon Taylor (Professor of Medicine)

University of Maryland School of Medicine

Phone: 410-706-6439

Email: staylor2@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place