Trial · NCT03066830

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

NCT03066830, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2021-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin. Trials, record NCT03066830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03066830

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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 Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
NCT number: NCT03066830
Status: Completed
Phases: Phase 3
Enrollment: 507 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: Sotagliflozin (SAR439954), Placebo, Metformin, Sulfonylurea
First posted: 2017-02-28
Last updated: 2021-05-11
Other registries' IDs: eudract:2016-002826-35
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 (HbA1c) at Week 26	Baseline to Week 26	Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline to Week 26	Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg	Baseline to Week 12	Missing data are imputed using the washout imputation method under the missing, not at random framework. An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in SBP at Week 12 for All Participants	Baseline to Week 12	Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 26	Baseline to Week 26	Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Secondary	Percentage of Participants With HbA1c <6.5% at Week 26	Week 26
Secondary	Percentage of Participants With HbA1c <7.0% at Week 26	Week 26
Other	Percentage of Participants With Hypoglycemic Events	Up to 79 weeks in the treatment period	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 \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\]. Participants may be reported in more than one category.

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 (HbA1c) at Week 26	Baseline to Week 26	Intent-to-treat (ITT) population included all randomized participants.	percentage HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline to Week 26	ITT population included all randomized participants.	millimole per liter (mmol/L)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg	Baseline to Week 12	Analysis was performed on ITT population in participants with baseline SBP ≥130 mmHg.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in SBP at Week 12 for All Participants	Baseline to Week 12	ITT population included all randomized participants .	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 26	Baseline to Week 26	ITT population included all randomized participants.	kilogram (kg)	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HbA1c <6.5% at Week 26	Week 26	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7.0% at Week 26	Week 26	ITT population included all randomized participants.	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Percentage of Participants With Hypoglycemic Events	Up to 79 weeks in the treatment period	Safety population was defined as all randomized participants who had received at least 1 dose of the double-blind investigational medicinal product.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	Placebo	0.06	Standard Error 0.082	percentage HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	Sotagliflozin 400 mg	-0.70	Standard Error 0.068	percentage HbA1c
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Placebo	0.277	Standard Error 0.2691	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 400 mg	-1.331	Standard Error 0.1844	millimole per liter (mmol/L)
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg	Placebo	-3.58	Standard Error 1.052	mmHg
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg	Sotagliflozin 400 mg	-4.41	Standard Error 1.061	mmHg
Change From Baseline in SBP at Week 12 for All Participants	Placebo	-0.69	Standard Deviation 0.826	mmHg
Change From Baseline in SBP at Week 12 for All Participants	Sotagliflozin 400 mg	-1.71	Standard Deviation 0.830	mmHg
Change From Baseline in Body Weight at Week 26	Placebo	-0.29	Standard Deviation 0.206	kilogram (kg)
Change From Baseline in Body Weight at Week 26	Sotagliflozin 400 mg	-1.70	Standard Deviation 0.215	kilogram (kg)

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	254
Overall Study	STARTED	Sotagliflozin 400 mg	253
Overall Study	COMPLETED	Placebo	221
Overall Study	COMPLETED	Sotagliflozin 400 mg	231
Overall Study	NOT COMPLETED	Placebo	33
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	22

Source ClinicalTrials.gov

Adverse events162

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	253
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 400 mg	22	254
other	Hyperglycaemia	Metabolism and nutrition disorders	Placebo	48	253
other	Hyperglycaemia	Metabolism and nutrition disorders	Sotagliflozin 400 mg	14	254
other	Nasopharyngitis	Infections and infestations	Placebo	23	253
other	Nasopharyngitis	Infections and infestations	Sotagliflozin 400 mg	21	254
other	Upper respiratory tract infection	Infections and infestations	Placebo	19	253
other	Upper respiratory tract infection	Infections and infestations	Sotagliflozin 400 mg	9	254
other	Urinary tract infection	Infections and infestations	Placebo	8	253
other	Urinary tract infection	Infections and infestations	Sotagliflozin 400 mg	19	254

1 to 10 of 162Source ClinicalTrials.gov

See all 162 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	253
Total, all-cause mortality	Sotagliflozin 400 mg	2	254
Total, other adverse events	Placebo	90	253
Total, other adverse events	Sotagliflozin 400 mg	71	254
Total, serious adverse events	Placebo	40	253
Total, serious adverse events	Sotagliflozin 400 mg	32	254

Source ClinicalTrials.gov

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 comparisons2

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

Comparison	Source
Sotagliflozin 400 mg vs Placebo: deaths from any cause	Trial comparisons
Sotagliflozin 400 mg vs Placebo: serious adverse events	Trial comparisons

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/NCT03066830

GET https://conductscience.org/api/trials/v1/NCT03066830/events?page=2

API reference For AI assistants