Trial Outcomes & Findings for Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin (NCT NCT02956044)

NCT ID: NCT02956044

Last Updated: 2021-07-22

Results Overview

Whole venous blood samples of 5 mL were be collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. Pharmacokinetic (PK) blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Cmax was obtained directly from experimental observations.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: Up to 72 hours
• Results posted on: 2021-07-22

Participant Flow

Participant milestones

Measure	Group 1: Bexagliflozin + Metformin Bexagliflozin tablets 20 mg alone, Metformin tablets 1000 mg alone, or Bexagliflozin 20 mg + Metformin 1000 mg	Group 2: Bexagliflozin + Glimepiride Bexagliflozin tablets 20 mg alone, Glimepiride tablets 2 mg alone, or Bexagliflozin 20 mg + Glimepiride 2 mg	Group 3: Bexagliflozin + Sitagliptin Bexagliflozin tablets 20 mg alone, Sitagliptin 100 mg alone, or Bexagliflozin 20 mg + Sitagliptin 100 mg
Overall Study STARTED	18	18	18
Overall Study COMPLETED	18	18	18
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

Baseline characteristics by cohort

Measure	Group 1: Bexagliflozin + Metformin n=18 Participants Bexagliflozin tablets 20 mg alone, Metformin tablets 1000 mg alone, or Bexagliflozin 20 mg + Metformin 1000 mg	Group 2: Bexagliflozin + Glimepiride n=18 Participants Bexagliflozin tablets 20 mg alone, Glimepiride tablets 2 mg alone, or Bexagliflozin 20 mg + Glimepiride 2 mg	Group 3: Bexagliflozin + Sitagliptin n=18 Participants Bexagliflozin tablets 20 mg alone, Sitagliptin 100 mg alone, or Bexagliflozin 20 mg + Sitagliptin 100 mg	Total n=54 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 15.69 • n=5 Participants	37.6 years STANDARD_DEVIATION 8.25 • n=7 Participants	43.6 years STANDARD_DEVIATION 14.52 • n=5 Participants	41.1 years STANDARD_DEVIATION 13.2 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	34 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	53 Participants n=4 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
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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	33 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Weight	79.0 kg STANDARD_DEVIATION 11.75 • n=5 Participants	77.9 kg STANDARD_DEVIATION 12.37 • n=7 Participants	79.0 kg STANDARD_DEVIATION 13.21 • n=5 Participants	78.6 kg STANDARD_DEVIATION 12.23 • n=4 Participants
Height	173.3 cm STANDARD_DEVIATION 9.16 • n=5 Participants	172.3 cm STANDARD_DEVIATION 6.45 • n=7 Participants	170.5 cm STANDARD_DEVIATION 8.37 • n=5 Participants	172.0 cm STANDARD_DEVIATION 8.01 • n=4 Participants

PRIMARY outcome

Timeframe: Up to 72 hours

Population: The study was designed to evaluate the potential bexagliflozin drug interactions. Study participants were dosed with bexagliflozin alone, other drug alone or both drugs sequentially. The pharmacokinetic parameters were calculated based on the specific analyte using samples collected after dosing of the drug. Therefore, not all samples were analyzed for all outcome measurements.

Whole venous blood samples of 5 mL were be collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. Pharmacokinetic (PK) blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Cmax was obtained directly from experimental observations.

Outcome measures

Measure	Group 1: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 1: Metformin Alone n=18 Participants Metformin: Metformin tablets, 1000 mg	Group 1: Bexagliflozin + Metformin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Metformin: Metformin tablets, 1000 mg	Group 2: Bexagliflozin Alone n=17 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 2: Glimepiride Alone n=18 Participants Glimepiride: Glimepiride tablets, 2 mg	Group 2: Bexagliflozin + Glimepiride n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Glimepiride: Glimepiride tablets, 2 mg	Group 3: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 3: Sitagliptin Alone n=18 Participants Sitagliptin: Sitagliptin tablets, 100 mg	Group 3: Bexagliflozin + Sitagliptin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Sitagliptin: Sitagliptin tablets, 100 mg
Cmax (Maximum Observed Plasma Concentration) Bexagliflozin PK parameters	124.6 ng/mL Geometric Coefficient of Variation 43.7	—	135.5 ng/mL Geometric Coefficient of Variation 40.0	158.6 ng/mL Geometric Coefficient of Variation 53.9	—	143.7 ng/mL Geometric Coefficient of Variation 37.9	117.1 ng/mL Geometric Coefficient of Variation 34.6	—	148.3 ng/mL Geometric Coefficient of Variation 22.1
Cmax (Maximum Observed Plasma Concentration) Metformin PK parameters	—	2067.6 ng/mL Geometric Coefficient of Variation 27.2	1965.2 ng/mL Geometric Coefficient of Variation 33.6	—	—	—	—	—	—
Cmax (Maximum Observed Plasma Concentration) Glimepiride PK parameters	—	—	—	—	59.9 ng/mL Geometric Coefficient of Variation 32.2	67.1 ng/mL Geometric Coefficient of Variation 29.5	—	—	—
Cmax (Maximum Observed Plasma Concentration) Sitagliptin PK parameters	—	—	—	—	—	—	—	356.6 ng/mL Geometric Coefficient of Variation 22.3	351.2 ng/mL Geometric Coefficient of Variation 32.9

PRIMARY outcome

Timeframe: Up to 72 hours

Population: The study was designed to evaluate the potential bexagliflozin drug interactions. Study participants were dosed with bexagliflozin alone, other drug alone or both drugs sequentially. The pharmacokinetic parameters were calculated based on the specific analyte using samples collected after dosing of the drug. Therefore, not all samples were analyzed for all outcome measurements.

Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Tmax was obtained directly from experimental observations.

Outcome measures

Measure	Group 1: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 1: Metformin Alone n=18 Participants Metformin: Metformin tablets, 1000 mg	Group 1: Bexagliflozin + Metformin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Metformin: Metformin tablets, 1000 mg	Group 2: Bexagliflozin Alone n=17 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 2: Glimepiride Alone n=18 Participants Glimepiride: Glimepiride tablets, 2 mg	Group 2: Bexagliflozin + Glimepiride n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Glimepiride: Glimepiride tablets, 2 mg	Group 3: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 3: Sitagliptin Alone n=18 Participants Sitagliptin: Sitagliptin tablets, 100 mg	Group 3: Bexagliflozin + Sitagliptin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Sitagliptin: Sitagliptin tablets, 100 mg
Tmax (Time of Maximum Observed Plasma Concentration) Bexagliflozin PK parameters	4.0 hours Interval 1.0 to 5.0	—	3.0 hours Interval 1.0 to 5.0	8.0 hours Interval 5.0 to 10.0	—	6.0 hours Interval 5.0 to 10.0	3.0 hours Interval 2.0 to 5.0	—	4.0 hours Interval 2.0 to 5.0
Tmax (Time of Maximum Observed Plasma Concentration) Metformin PK parameters	—	2.5 hours Interval 1.0 to 3.0	2.0 hours Interval 1.0 to 5.0	—	0 hours Interval 0.0 to 0.0	—	—	—	—
Tmax (Time of Maximum Observed Plasma Concentration) Glimepiride PK parameters	—	—	—	—	5.5 hours Interval 1.0 to 10.0	7.0 hours Interval 1.0 to 10.0	—	—	—
Tmax (Time of Maximum Observed Plasma Concentration) Sitagliptin PK parameters	—	—	—	—	—	—	—	2.5 hours Interval 1.0 to 5.0	2.5 hours Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: Up to 72 hours

Population: The study was designed to evaluate the potential bexagliflozin drug interactions. Study participants were dosed with bexagliflozin alone, other drug alone or both drugs sequentially. The pharmacokinetic parameters were calculated based on the specific analyte using samples collected after dosing of the drug. Therefore, not all samples were analyzed for all outcome measurements.

Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. T1/2 was obtained directly from experimental observations.

Outcome measures

Measure	Group 1: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 1: Metformin Alone n=18 Participants Metformin: Metformin tablets, 1000 mg	Group 1: Bexagliflozin + Metformin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Metformin: Metformin tablets, 1000 mg	Group 2: Bexagliflozin Alone n=17 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 2: Glimepiride Alone n=18 Participants Glimepiride: Glimepiride tablets, 2 mg	Group 2: Bexagliflozin + Glimepiride n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Glimepiride: Glimepiride tablets, 2 mg	Group 3: Bexagliflozin Alone n=17 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 3: Sitagliptin Alone n=18 Participants Sitagliptin: Sitagliptin tablets, 100 mg	Group 3: Bexagliflozin + Sitagliptin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Sitagliptin: Sitagliptin tablets, 100 mg
T1/2 (Apparent Terminal Elimination Half-life) Bexagliflozin PK parameters	10.3 hours Geometric Coefficient of Variation 30.4	—	7.8 hours Geometric Coefficient of Variation 48.6	8.0 hours Geometric Coefficient of Variation 33.3	—	7.8 hours Geometric Coefficient of Variation 34.4	12.6 hours Geometric Coefficient of Variation 48	—	13.3 hours Geometric Coefficient of Variation 38.2
T1/2 (Apparent Terminal Elimination Half-life) Sitagliptin PK parameters	—	—	—	—	—	—	—	14.3 hours Geometric Coefficient of Variation 22.3	14.8 hours Geometric Coefficient of Variation 24.5
T1/2 (Apparent Terminal Elimination Half-life) Metformin PK parameters	—	9.0 hours Geometric Coefficient of Variation 31.8	10.2 hours Geometric Coefficient of Variation 32.5	—	—	—	—	—	—
T1/2 (Apparent Terminal Elimination Half-life) Glimepiride PK parameters	—	—	—	—	7.8 hours Geometric Coefficient of Variation 46.8	6.6 hours Geometric Coefficient of Variation 57.8	—	—	—

PRIMARY outcome

Timeframe: Up to 72 hours

Population: The study was designed to evaluate the potential bexagliflozin drug interactions. Study participants were dosed with bexagliflozin alone, other drug alone or both drugs sequentially. The pharmacokinetic parameters were calculated based on the specific analyte using samples collected after dosing of the drug. Therefore, not all samples were analyzed for all outcome measurements.

Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. AUC0-inf was estimated for each subject.

Outcome measures

Measure	Group 1: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 1: Metformin Alone n=18 Participants Metformin: Metformin tablets, 1000 mg	Group 1: Bexagliflozin + Metformin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Metformin: Metformin tablets, 1000 mg	Group 2: Bexagliflozin Alone n=17 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 2: Glimepiride Alone n=18 Participants Glimepiride: Glimepiride tablets, 2 mg	Group 2: Bexagliflozin + Glimepiride n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Glimepiride: Glimepiride tablets, 2 mg	Group 3: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 3: Sitagliptin Alone n=18 Participants Sitagliptin: Sitagliptin tablets, 100 mg	Group 3: Bexagliflozin + Sitagliptin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Sitagliptin: Sitagliptin tablets, 100 mg
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) Bexagliflozin PK parameters	1154.4 h*ng/mL Geometric Coefficient of Variation 35.1	—	1008.6 h*ng/mL Geometric Coefficient of Variation 40.2	1204.9 h*ng/mL Geometric Coefficient of Variation 48.6	—	1162.2 h*ng/mL Geometric Coefficient of Variation 47.8	1011.8 h*ng/mL Geometric Coefficient of Variation 21.5	—	1158.1 h*ng/mL Geometric Coefficient of Variation 21.9
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) Metformin PK parameters	—	13351.9 h*ng/mL Geometric Coefficient of Variation 22.5	13784.6 h*ng/mL Geometric Coefficient of Variation 26.0	—	—	—	—	—	—
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) Glimepiride PK parameters	—	—	—	—	496.1 h*ng/mL Geometric Coefficient of Variation 53.3	633.0 h*ng/mL Geometric Coefficient of Variation 38.5	—	—	—
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) Sitagliptin PK parameters	—	—	—	—	—	—	—	3579.6 h*ng/mL Geometric Coefficient of Variation 14.7	3692.8 h*ng/mL Geometric Coefficient of Variation 16.9

SECONDARY outcome

Timeframe: up to 0-72 hr

Population: Only subjects with data in the specific category is analyzed

Pre-dose urine samples were collected from -12 to 0 h for baseline measurement. Subjects was instructed to empty their bladder prior to dosing. Post-dose urine was collected in 4 batches for Groups 1 and 2 at 0 to 12 h, 12 to 24 h, 24 o 36 h, and 36 to 48 h collections. Post-dose urine was collected in batches for Group 3 at 0 to 12 h, 12 to 24 h, 24 to 36 h, 36 to 48 h, 48 to 60 h and 60 to 72 h.

Outcome measures

Measure	Group 1: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 1: Metformin Alone n=18 Participants Metformin: Metformin tablets, 1000 mg	Group 1: Bexagliflozin + Metformin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Metformin: Metformin tablets, 1000 mg	Group 2: Bexagliflozin Alone n=17 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 2: Glimepiride Alone n=17 Participants Glimepiride: Glimepiride tablets, 2 mg	Group 2: Bexagliflozin + Glimepiride n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Glimepiride: Glimepiride tablets, 2 mg	Group 3: Bexagliflozin Alone n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 3: Sitagliptin Alone n=18 Participants Sitagliptin: Sitagliptin tablets, 100 mg	Group 3: Bexagliflozin + Sitagliptin n=18 Participants Bexagliflozin: Bexagliflozin tablets, 20 mg Sitagliptin: Sitagliptin tablets, 100 mg
Urinary Glucose Excretion up to 0-72 hr 24 - 36 hours	23.94 g Standard Deviation 9.16	0.04 g Standard Deviation 0.04	19.50 g Standard Deviation 8.94	29.79 g Standard Deviation 10.24	0.20 g Standard Deviation 0.42	28.46 g Standard Deviation 11.37	22.31 g Standard Deviation 8.97	0.17 g Standard Deviation 0.56	24.15 g Standard Deviation 9.27
Urinary Glucose Excretion up to 0-72 hr 0 - 12 hours	31.57 g Standard Deviation 8.06	0.02 g Standard Deviation 0.01	26.26 g Standard Deviation 8.86	36.99 g Standard Deviation 14.24	1.26 g Standard Deviation 4.37	31.02 g Standard Deviation 11.19	29.01 g Standard Deviation 6.84	0.03 g Standard Deviation 0.01	23.94 g Standard Deviation 7.17
Urinary Glucose Excretion up to 0-72 hr 48 - 60 hours	—	—	—	—	—	—	11.32 g Standard Deviation 8.09	0.05 g Standard Deviation 0.07	11.50 g Standard Deviation 7.52
Urinary Glucose Excretion up to 0-72 hr 12 - 24 hours	17.32 g Standard Deviation 11.81	0.04 g Standard Deviation 0.03	22.57 g Standard Deviation 8.29	26.85 g Standard Deviation 9.51	0.04 g Standard Deviation 0.05	22.59 g Standard Deviation 11.15	24.38 g Standard Deviation 7.92	0.04 g Standard Deviation 0.05	22.85 g Standard Deviation 9.59
Urinary Glucose Excretion up to 0-72 hr 36 - 48 hours	8.91 g Standard Deviation 4.97	0.02 g Standard Deviation 0.01	5.53 g Standard Deviation 4.17	11.03 g Standard Deviation 7.84	0.03 g Standard Deviation 0.01	9.34 g Standard Deviation 7.55	9.83 g Standard Deviation 6.67	0.03 g Standard Deviation 0.01	10.17 g Standard Deviation 5.23
Urinary Glucose Excretion up to 0-72 hr 60 - 72 hours	—	—	—	—	—	—	2.67 g Standard Deviation 3.55	0.02 g Standard Deviation 0.01	2.70 g Standard Deviation 2.91

Adverse Events

Group 1: Bexagliflozin Alone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1: Metformin Alone

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Group 1: Bexagliflozin + Metformin

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Group 2: Bexagliflozin Alone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Group 2: Glimepiride Alone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 2: Bexagliflozin + Glimepiride

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 3: Bexagliflozin Alone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 3: Sitagliptin Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 3: Bexagliflozin + Sitagliptin

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	Group 1: Bexagliflozin Alone n=18 participants at risk Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 1: Metformin Alone n=18 participants at risk Metformin: Metformin tablets, 1000 mg	Group 1: Bexagliflozin + Metformin n=18 participants at risk Bexagliflozin: Bexagliflozin tablets, 20 mg Metformin: Metformin tablets, 1000 mg	Group 2: Bexagliflozin Alone n=18 participants at risk Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 2: Glimepiride Alone n=18 participants at risk Glimepiride: Glimepiride tablets, 2 mg	Group 2: Bexagliflozin + Glimepiride n=18 participants at risk Bexagliflozin: Bexagliflozin tablets, 20 mg Glimepiride: Glimepiride tablets, 2 mg	Group 3: Bexagliflozin Alone n=18 participants at risk Bexagliflozin: Bexagliflozin tablets, 20 mg	Group 3: Sitagliptin Alone n=18 participants at risk Sitagliptin: Sitagliptin tablets, 100 mg	Group 3: Bexagliflozin + Sitagliptin n=18 participants at risk Bexagliflozin: Bexagliflozin tablets, 20 mg Sitagliptin: Sitagliptin tablets, 100 mg
Gastrointestinal disorders Diarrhea	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	50.0% 9/18 • Number of events 9 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	38.9% 7/18 • Number of events 7 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Gastrointestinal disorders Nausea	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	16.7% 3/18 • Number of events 3 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	11.1% 2/18 • Number of events 2 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	11.1% 2/18 • Number of events 2 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	16.7% 3/18 • Number of events 3 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	11.1% 2/18 • Number of events 2 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	11.1% 2/18 • Number of events 2 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Gastrointestinal disorders Flatulence	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Tenderness	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Vessel puncture site haemorrhage	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Puncture site pain	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Puncture site swelling	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Fatigue	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Xerosis	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Catheter site induration	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
General disorders Catheter site pain	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Metabolism and nutrition disorders Hypoglycemia	11.1% 2/18 • Number of events 2 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	16.7% 3/18 • Number of events 3 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	22.2% 4/18 • Number of events 4 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	22.2% 4/18 • Number of events 4 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Nervous system disorders Dizziness	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Nervous system disorders Paresthesia	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Skin and subcutaneous tissue disorders Swelling of face	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	5.6% 1/18 • Number of events 1 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.	0.00% 0/18 • Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.

Additional Information

Program Director

Translational Medicine Group

Phone: 617-726-4236

Email: yhalvorsen@ccib.mgh.harvard.edu

Results disclosure agreements

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