Trial · NCT03332771

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

NCT03332771, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2021-05-11

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy. Trials, record NCT03332771. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03332771

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
NCT number: NCT03332771
Status: Completed
Phases: Phase 3
Enrollment: 954 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: Sotagliflozin (SAR439954), Glimepiride, Metformin, Placebo, Placebo
First posted: 2017-11-06
Last updated: 2021-05-11
Other registries' IDs: eudract:2016-001801-17
Results first posted: 2021-05-11

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin A1c at Week 52	Baseline, Week 52	An analysis of covariance (ANCOVA) model was used for the analysis.
Secondary	Change From Baseline in Hemoglobin A1c at Week 26	Baseline, Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 26 and 52	Baseline, Week 26, Week 52	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12	Baseline, Week 12	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12	Baseline, Week 12	An ANCOVA model was used for the analysis.
Secondary	Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event	Up to Week 52	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).
Secondary	Percentage of Participants With Adverse Events (AEs)	Up to Week 52	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.
Other	Percentage of Participants With Hypoglycemic Events	Up to Week 52	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 \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\].

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hemoglobin A1c at Week 52	Baseline, Week 52	Intend to treat (ITT) population included all randomized participants. Missing data are imputed using the retrieved dropouts imputation method.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hemoglobin A1c at Week 26	Baseline, Week 26	ITT population included all randomized participants. Missing data are imputed using the washout imputation method.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 26 and 52	Baseline, Week 26, Week 52	ITT population included all randomized participants. Missing data are imputed using the retrieved dropouts \& washout imputation method.	kilogram (kg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12	Baseline, Week 12	Analysis was performed on ITT population in participants with baseline SBP ≥130 mmHg. Missing data are imputed using washout imputation method.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12	Baseline, Week 12	ITT population included all randomized participants. Missing data are imputed using washout imputation method under the missing not at random framework.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event	Up to Week 52	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Adverse Events (AEs)	Up to Week 52	Safety population included all participants who had received at least one dose of study drug.	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Percentage of Participants With Hypoglycemic Events	Up to Week 52	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	NUMBER

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Hemoglobin A1c at Week 52	Placebo		-0.40	Standard Error 0.187	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 52	Sotagliflozin 400 mg		-0.65	Standard Error 0.101	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 52	Sotagliflozin 200 mg		-0.49	Standard Error 0.114	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 52	Glimepiride		-0.61	Standard Error 0.093	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 26	Placebo		-0.41	Standard Error 0.097	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 26	Sotagliflozin 400 mg		-0.77	Standard Error 0.076	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 26	Sotagliflozin 200 mg		-0.61	Standard Error 0.098	percentage of HbA1c
Change From Baseline in Hemoglobin A1c at Week 26	Glimepiride		-1.02	Standard Error 0.075	percentage of HbA1c
Change From Baseline in Body Weight at Week 26 and 52	Placebo	Change at Week 26	-1.26	Standard Error 0.329	kilogram (kg)
Change From Baseline in Body Weight at Week 26 and 52	Sotagliflozin 400 mg	Change at Week 26	-2.75	Standard Error 0.257	kilogram (kg)

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	159
Overall Study	STARTED	Sotagliflozin 400 mg	317
Overall Study	STARTED	Sotagliflozin 200 mg	160
Overall Study	STARTED	Glimepiride	318
Overall Study	COMPLETED	Placebo	125
Overall Study	COMPLETED	Sotagliflozin 400 mg	266
Overall Study	COMPLETED	Sotagliflozin 200 mg	128
Overall Study	COMPLETED	Glimepiride	270
Overall Study	NOT COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	51

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events288

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo	11	159
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 400 mg	14	317
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 200 mg	8	159
other	Diarrhoea	Gastrointestinal disorders	Glimepiride	7	317
other	Vulvovaginal mycotic infection	Infections and infestations	Placebo	2	159
other	Vulvovaginal mycotic infection	Infections and infestations	Sotagliflozin 400 mg	19	317
other	Vulvovaginal mycotic infection	Infections and infestations	Sotagliflozin 200 mg	6	159
other	Vulvovaginal mycotic infection	Infections and infestations	Glimepiride	2	317
other	Hyperglycaemia	Metabolism and nutrition disorders	Placebo	8	159
other	Hyperglycaemia	Metabolism and nutrition disorders	Sotagliflozin 400 mg	5	317

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	159
Total, all-cause mortality	Sotagliflozin 400 mg	1	317
Total, all-cause mortality	Sotagliflozin 200 mg	0	159
Total, all-cause mortality	Glimepiride	2	317
Total, other adverse events	Placebo	30	159
Total, other adverse events	Sotagliflozin 400 mg	49	317
Total, other adverse events	Sotagliflozin 200 mg	21	159
Total, other adverse events	Glimepiride	22	317
Total, serious adverse events	Placebo	11	159
Total, serious adverse events	Sotagliflozin 400 mg	17	317

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03332771

GET https://conductscience.org/api/trials/v1/NCT03332771/results?page=2

API reference For AI assistants