Trial Outcomes & Findings for Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control (NCT NCT03242252)

NCT ID: NCT03242252

Last Updated: 2021-06-25

Results Overview

An Analysis of covariance (ANCOVA) model was used for analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

787 participants

Primary outcome timeframe

Baseline to Week 26

Results posted on

2021-06-25

Participant Flow

Participants took part in the study at 166 investigative sites in the United States, Argentina, Brazil, Canada, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, and Ukraine from 16 August 2017 to 25 October 2019.

Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups: Placebo or Sotagliflozin 200 milligrams (mg) or Sotagliflozin 400 mg. Participants were randomly assigned in the ratio of 1:1:1 to these reporting groups.

Participant milestones

Participant milestones
Measure	Placebo Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Overall Study STARTED	260	263	264
Overall Study COMPLETED	224	240	232
Overall Study NOT COMPLETED	36	23	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Overall Study At the Participant's own Request	18	10	15
Overall Study Adverse Event	8	6	9
Overall Study Poor Compliance to Protocol	0	2	3
Overall Study Study Terminated by Sponsor	1	0	0
Overall Study Reason not Specified	4	4	1
Overall Study Lost to Follow-up	5	1	4

Baseline Characteristics

Number analyzed specifies the number of participants evaluated for the parameter.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.	Total n=787 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 8.1 • n=260 Participants	69.6 years STANDARD_DEVIATION 7.5 • n=263 Participants	69.5 years STANDARD_DEVIATION 8.2 • n=264 Participants	69.5 years STANDARD_DEVIATION 7.9 • n=787 Participants
Sex: Female, Male Female	111 Participants n=260 Participants	120 Participants n=263 Participants	112 Participants n=264 Participants	343 Participants n=787 Participants
Sex: Female, Male Male	149 Participants n=260 Participants	143 Participants n=263 Participants	152 Participants n=264 Participants	444 Participants n=787 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=260 Participants	67 Participants n=263 Participants	64 Participants n=264 Participants	198 Participants n=787 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	193 Participants n=260 Participants	196 Participants n=263 Participants	200 Participants n=264 Participants	589 Participants n=787 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=260 Participants	0 Participants n=263 Participants	0 Participants n=264 Participants	0 Participants n=787 Participants
Race (NIH/OMB) American Indian or Alaska Native	15 Participants n=260 Participants	9 Participants n=263 Participants	20 Participants n=264 Participants	44 Participants n=787 Participants
Race (NIH/OMB) Asian	5 Participants n=260 Participants	7 Participants n=263 Participants	8 Participants n=264 Participants	20 Participants n=787 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=260 Participants	1 Participants n=263 Participants	0 Participants n=264 Participants	2 Participants n=787 Participants
Race (NIH/OMB) Black or African American	12 Participants n=260 Participants	14 Participants n=263 Participants	15 Participants n=264 Participants	41 Participants n=787 Participants
Race (NIH/OMB) White	220 Participants n=260 Participants	231 Participants n=263 Participants	215 Participants n=264 Participants	666 Participants n=787 Participants
Race (NIH/OMB) More than one race	3 Participants n=260 Participants	0 Participants n=263 Participants	3 Participants n=264 Participants	6 Participants n=787 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=260 Participants	1 Participants n=263 Participants	3 Participants n=264 Participants	8 Participants n=787 Participants
Region of Enrollment Colombia	12 participants n=260 Participants	6 participants n=263 Participants	14 participants n=264 Participants	32 participants n=787 Participants
Region of Enrollment Argentina	8 participants n=260 Participants	8 participants n=263 Participants	8 participants n=264 Participants	24 participants n=787 Participants
Region of Enrollment Romania	6 participants n=260 Participants	14 participants n=263 Participants	13 participants n=264 Participants	33 participants n=787 Participants
Region of Enrollment Hungary	21 participants n=260 Participants	23 participants n=263 Participants	13 participants n=264 Participants	57 participants n=787 Participants
Region of Enrollment United States	66 participants n=260 Participants	72 participants n=263 Participants	62 participants n=264 Participants	200 participants n=787 Participants
Region of Enrollment Ukraine	12 participants n=260 Participants	13 participants n=263 Participants	14 participants n=264 Participants	39 participants n=787 Participants
Region of Enrollment Spain	9 participants n=260 Participants	10 participants n=263 Participants	15 participants n=264 Participants	34 participants n=787 Participants
Region of Enrollment Russia	15 participants n=260 Participants	10 participants n=263 Participants	14 participants n=264 Participants	39 participants n=787 Participants
Region of Enrollment Canada	11 participants n=260 Participants	18 participants n=263 Participants	12 participants n=264 Participants	41 participants n=787 Participants
Region of Enrollment Poland	29 participants n=260 Participants	23 participants n=263 Participants	32 participants n=264 Participants	84 participants n=787 Participants
Region of Enrollment Brazil	22 participants n=260 Participants	22 participants n=263 Participants	22 participants n=264 Participants	66 participants n=787 Participants
Region of Enrollment Italy	5 participants n=260 Participants	6 participants n=263 Participants	8 participants n=264 Participants	19 participants n=787 Participants
Region of Enrollment South Africa	7 participants n=260 Participants	3 participants n=263 Participants	12 participants n=264 Participants	22 participants n=787 Participants
Region of Enrollment Mexico	14 participants n=260 Participants	13 participants n=263 Participants	7 participants n=264 Participants	34 participants n=787 Participants
Region of Enrollment Israel	23 participants n=260 Participants	17 participants n=263 Participants	16 participants n=264 Participants	56 participants n=787 Participants
Region of Enrollment Germany	0 participants n=260 Participants	5 participants n=263 Participants	2 participants n=264 Participants	7 participants n=787 Participants
Hemoglobin A1c (HbA1c)	8.33 percentage of HbA1c STANDARD_DEVIATION 1.00 • n=260 Participants • Number analyzed specifies the number of participants evaluated for the parameter.	8.33 percentage of HbA1c STANDARD_DEVIATION 0.9 • n=262 Participants • Number analyzed specifies the number of participants evaluated for the parameter.	8.31 percentage of HbA1c STANDARD_DEVIATION 0.94 • n=264 Participants • Number analyzed specifies the number of participants evaluated for the parameter.	8.32 percentage of HbA1c STANDARD_DEVIATION 0.95 • n=786 Participants • Number analyzed specifies the number of participants evaluated for the parameter.
Systolic Blood Pressure (SBP)	140.59 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.59 • n=260 Participants	140.31 millimeter of mercury (mmHg) STANDARD_DEVIATION 15.15 • n=263 Participants	141.71 millimeter of mercury (mmHg) STANDARD_DEVIATION 15.01 • n=264 Participants	140.87 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.91 • n=787 Participants

PRIMARY outcome

Timeframe: Baseline to Week 26

Population: Intent-to-treat (ITT) population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.

An Analysis of covariance (ANCOVA) model was used for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Change From Baseline in HbA1c at Week 26	-0.22 percentage of HbA1c Standard Error 0.061	-0.32 percentage of HbA1c Standard Error 0.060	-0.46 percentage of HbA1c Standard Error 0.060

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts \& washout imputation method.

An ANCOVA model was used for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	-0.374 millimole per liter (mmol/L) Standard Error 0.1949	-0.961 millimole per liter (mmol/L) Standard Error 0.1715	-0.852 millimole per liter (mmol/L) Standard Error 0.1668

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Analysis population included participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts \& washout imputation method.

An ANCOVA model was used for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=175 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=162 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=182 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12	-5.18 mmHg Standard Error 1.462	-7.46 mmHg Standard Error 1.597	-7.71 mmHg Standard Error 1.247

SECONDARY outcome

Timeframe: Baseline to Week 12

An ANCOVA model was used for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Change From Baseline in SBP at Week 12 for All Participants	-3.31 mmHg Standard Error 1.037	-4.91 mmHg Standard Error 1.010	-4.94 mmHg Standard Error 0.983

SECONDARY outcome

Timeframe: Baseline to Week 26

An ANCOVA model was used for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Change From Baseline in Body Weight at Week 26	-0.38 kilogram (kg) Standard Error 0.262	-1.66 kilogram (kg) Standard Error 0.246	-1.20 kilogram (kg) Standard Error 0.257

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Analysis population included participants with baseline UACR \>30 mg/g in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.

An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)	-18.71 percent change Standard Error NA An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.	-43.68 percent change Standard Error NA An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.	-48.12 percent change Standard Error NA An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

SECONDARY outcome

Timeframe: Week 26

Population: ITT population included all randomized participants or participants analyzed according to their randomized treatment.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Percentage of Participants With HbA1c <6.5% at Week 26	4.2 percentage of participants	5.7 percentage of participants	5.7 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: ITT population included all randomized participants or participants analyzed according to their randomized treatment.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=263 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=264 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Percentage of Participants With HbA1c <7.0% at Week 26	13.5 percentage of participants	19.4 percentage of participants	20.8 percentage of participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=267 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=260 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	78.1 percentage of participants	76.8 percentage of participants	74.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 60 weeks

Population: Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.

Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\].

Outcome measures

Outcome measures
Measure	Placebo n=260 Participants Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=267 Participants Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.	Sotagliflozin 400 mg n=260 Participants Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.
Percentage of Participants With Hypoglycemic Events Any hypoglycemia	38.1 percentage of participants	41.9 percentage of participants	35.4 percentage of participants
Percentage of Participants With Hypoglycemic Events Documented symptomatic hypoglycemia	26.9 percentage of participants	29.6 percentage of participants	22.3 percentage of participants
Percentage of Participants With Hypoglycemic Events Severe or documented symptomatic hypoglycemia	26.9 percentage of participants	29.6 percentage of participants	22.3 percentage of participants

Adverse Events

Placebo

Serious events: 48 serious events

Other events: 80 other events

Deaths: 3 deaths

Sotagliflozin 200 mg

Serious events: 43 serious events

Other events: 72 other events

Deaths: 2 deaths

Sotagliflozin 400 mg

Serious events: 44 serious events

Other events: 77 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=260 participants at risk Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.	Sotagliflozin 200 mg n=267 participants at risk Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.	Sotagliflozin 400 mg n=260 participants at risk Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population.
Gastrointestinal disorders Diarrhoea	5.0% 13/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.6% 15/267 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	8.5% 22/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Metabolism and nutrition disorders Vitamin D deficiency	11.5% 30/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	9.0% 24/267 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	9.2% 24/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Nasopharyngitis	5.0% 13/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	2.6% 7/267 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	4.6% 12/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Upper respiratory tract infection	6.9% 18/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	6.0% 16/267 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	5.0% 13/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.
Infections and infestations Urinary tract infection	8.1% 21/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	7.1% 19/267 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.	8.1% 21/260 • Up to 60 weeks Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received. Four participants randomized to sotagliflozin 400 mg were dosed with both sotagliflozin 200 mg and 400 mg. These participants were included in the sotagliflozin 200 mg arm in the safety population. Hypoglycemia was captured and handled separately from other adverse events and is reported in the outcome measure section.

Additional Information

Medical Affairs

Lexicon Pharmaceuticals, Inc.

Phone: (510) 338-6064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
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