Trial Outcomes & Findings for Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy (NCT NCT03332771)

NCT ID: NCT03332771

Last Updated: 2021-05-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

954 participants

Primary outcome timeframe

Baseline, Week 52

Results posted on

2021-05-11

Participant Flow

Participants took part in the study at 138 investigative sites in United States, Bulgaria, Hungary, and Slovakia from 01 December 2017 to 06 September 2019.

Participants with diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 4 treatment groups: Placebo or Sotagliflozin 200 mg or Sotagliflozin 400 mg or Glimepiride. Participants were randomly assigned in the ratio of 1:1:2:2 to these reporting groups. Total of 954 participants were enrolled in study, out of which 952 were randomized and treated.

Participant milestones

Participant milestones
Measure	Placebo Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Overall Study STARTED	159	317	160	318
Overall Study COMPLETED	125	266	128	270
Overall Study NOT COMPLETED	34	51	32	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Overall Study Adverse Event	6	4	1	3
Overall Study Poor Compliance to Protocol	0	1	0	1
Overall Study Lost to Follow-up	2	2	1	2
Overall Study At the Participant's own request	20	26	14	23
Overall Study Reason Not Specified	6	18	16	19

Baseline Characteristics

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=160 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=318 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Total n=954 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 11.2 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.4 • n=7 Participants	58.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	59.8 years STANDARD_DEVIATION 9.6 • n=4 Participants	59.4 years STANDARD_DEVIATION 10.2 • n=21 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	157 Participants n=7 Participants	75 Participants n=5 Participants	143 Participants n=4 Participants	452 Participants n=21 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	160 Participants n=7 Participants	85 Participants n=5 Participants	175 Participants n=4 Participants	502 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=5 Participants	85 Participants n=7 Participants	53 Participants n=5 Participants	111 Participants n=4 Participants	297 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=5 Participants	230 Participants n=7 Participants	106 Participants n=5 Participants	207 Participants n=4 Participants	653 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	34 Participants n=7 Participants	19 Participants n=5 Participants	36 Participants n=4 Participants	102 Participants n=21 Participants
Race (NIH/OMB) White	141 Participants n=5 Participants	269 Participants n=7 Participants	136 Participants n=5 Participants	277 Participants n=4 Participants	823 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Bulgaria	7 participants n=5 Participants	17 participants n=7 Participants	5 participants n=5 Participants	16 participants n=4 Participants	45 participants n=21 Participants
Region of Enrollment Hungary	22 participants n=5 Participants	48 participants n=7 Participants	24 participants n=5 Participants	42 participants n=4 Participants	136 participants n=21 Participants
Region of Enrollment Slovakia	12 participants n=5 Participants	28 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants	80 participants n=21 Participants
Region of Enrollment United States	118 participants n=5 Participants	224 participants n=7 Participants	121 participants n=5 Participants	230 participants n=4 Participants	693 participants n=21 Participants
Hemoglobin A1c (HbA1c)	8.12 percentage of HbA1c STANDARD_DEVIATION 0.73 • n=5 Participants	8.09 percentage of HbA1c STANDARD_DEVIATION 0.78 • n=7 Participants	8.11 percentage of HbA1c STANDARD_DEVIATION 0.86 • n=5 Participants	8.07 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=4 Participants	8.09 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=21 Participants
Systolic Blood Pressure (SBP)	133.23 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.90 • n=5 Participants	133.17 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.37 • n=7 Participants	132.78 millimeter of mercury (mmHg) STANDARD_DEVIATION 13.29 • n=5 Participants	134.66 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.43 • n=4 Participants	133.61 millimeter of mercury (mmHg) STANDARD_DEVIATION 14.30 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: Intend to treat (ITT) population included all randomized participants. Missing data are imputed using the retrieved dropouts imputation method.

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

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=160 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=318 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Change From Baseline in Hemoglobin A1c at Week 52	-0.40 percentage of HbA1c Standard Error 0.187	-0.65 percentage of HbA1c Standard Error 0.101	-0.49 percentage of HbA1c Standard Error 0.114	-0.61 percentage of HbA1c Standard Error 0.093

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants. Missing data are imputed using the washout imputation method.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=160 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=318 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Change From Baseline in Hemoglobin A1c at Week 26	-0.41 percentage of HbA1c Standard Error 0.097	-0.77 percentage of HbA1c Standard Error 0.076	-0.61 percentage of HbA1c Standard Error 0.098	-1.02 percentage of HbA1c Standard Error 0.075

SECONDARY outcome

Timeframe: Baseline, Week 26, Week 52

Population: ITT population included all randomized participants. Missing data are imputed using the retrieved dropouts \& washout imputation method.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=160 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=318 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Change From Baseline in Body Weight at Week 26 and 52 Change at Week 52	-0.47 kilogram (kg) Standard Error 1.406	-2.64 kilogram (kg) Standard Error 0.503	-1.74 kilogram (kg) Standard Error 0.707	0.94 kilogram (kg) Standard Error 0.452
Change From Baseline in Body Weight at Week 26 and 52 Change at Week 26	-1.26 kilogram (kg) Standard Error 0.329	-2.75 kilogram (kg) Standard Error 0.257	-2.24 kilogram (kg) Standard Error 0.336	0.70 kilogram (kg) Standard Error 0.256

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on ITT population in participants with baseline SBP ≥130 mmHg. Missing data are imputed using washout imputation method.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=161 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=81 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=175 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12	-5.34 mmHg Standard Error 1.451	-8.03 mmHg Standard Error 1.064	-9.12 mmHg Standard Error 1.466	-3.86 mmHg Standard Error 1.081

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Missing data are imputed using washout imputation method under the missing not at random framework.

An ANCOVA model was used for the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=160 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=318 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12	-2.64 mmHg Standard Error 1.013	-4.70 mmHg Standard Error 0.791	-4.77 mmHg Standard Error 1.033	-0.68 mmHg Standard Error 0.795

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT population included all randomized participants.

Documented symptomatic hypoglycemia includes the 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).

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=160 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=318 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event	0.63 percentage of participants	1.26 percentage of participants	3.75 percentage of participants	16.67 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety population included all participants who had received at least one dose of study drug.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Placebo n=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=159 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=317 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Percentage of Participants With Adverse Events (AEs)	57.2 percentage of participants	59.9 percentage of participants	56.6 percentage of participants	49.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 52

Population: Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).

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=159 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 Participants Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=159 Participants Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=317 Participants Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Percentage of Participants With Hypoglycemic Events Any hypoglycemia	2.5 percentage of participants	4.1 percentage of participants	6.3 percentage of participants	25.9 percentage of participants
Percentage of Participants With Hypoglycemic Events Documented symptomatic hypoglycemia	0.6 percentage of participants	1.3 percentage of participants	3.8 percentage of participants	16.7 percentage of participants
Percentage of Participants With Hypoglycemic Events Severe or documented symptomatic hypoglycemia	0.6 percentage of participants	1.3 percentage of participants	3.8 percentage of participants	16.7 percentage of participants

Adverse Events

Placebo

Serious events: 11 serious events

Other events: 30 other events

Deaths: 2 deaths

Sotagliflozin 400 mg

Serious events: 17 serious events

Other events: 49 other events

Deaths: 1 deaths

Sotagliflozin 200 mg

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Glimepiride

Serious events: 14 serious events

Other events: 22 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=159 participants at risk Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 400 mg n=317 participants at risk Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Sotagliflozin 200 mg n=159 participants at risk Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.	Glimepiride n=317 participants at risk Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Gastrointestinal disorders Diarrhoea	6.9% 11/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	4.4% 14/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	5.0% 8/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	2.2% 7/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.
Infections and infestations Vulvovaginal mycotic infection	1.3% 2/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	6.0% 19/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	3.8% 6/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	0.63% 2/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	5.0% 8/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	1.6% 5/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	1.3% 2/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	0.63% 2/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.
Nervous system disorders Headache	6.9% 11/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	4.4% 14/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	4.4% 7/159 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.	3.8% 12/317 • First dose of study drug to last dose of study drug (up to 52 weeks) + 2 weeks Safety population included all participants who had received at least one dose of study drug.

Additional Information

Medical Affairs

Lexicon Pharmaceuticals, Inc.

Phone: 510-338-6064

Email: [email protected]

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