Trial · NCT03351478

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

NCT03351478, 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 and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin. Trials, record NCT03351478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03351478

On this page

Trial

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

Title: Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
NCT number: NCT03351478
Status: Completed
Phases: Phase 3
Enrollment: 770 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: Sotagliflozin, Empagliflozin, Placebo, Placebo
First posted: 2017-11-22
Last updated: 2021-05-11
Other registries' IDs: eudract:2016-001803-22
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, Week 26	An analysis of covariance (ANCOVA) model was used for the analysis.
Secondary	Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg	Baseline, Week 12	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Baseline, Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline, Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 26	Baseline, Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Sitting SBP at Week 12 for All Participants	Baseline, Week 12	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

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, Week 26	Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.	percentage of HbA1c	MEAN
SECONDARY	Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg	Baseline, Week 12	Participants from the ITT population, all randomized participants with data available at the given time point for analysis. Missing data was imputed using washout imputation method.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Baseline, Week 26	ITT population included all randomized participants. Missing data was imputed using washout imputation method under the missing not at random framework.	millimole per liter (mmol/L)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline, Week 26	ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 26	Baseline, Week 26	ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.	kilogram (kg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sitting SBP at Week 12 for All Participants	Baseline, Week 12	ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HbA1c <6.5% at Week 26	Week 26	ITT population included all randomized participants. Missing data at Week 26 were assigned a status of nonresponder in the analysis.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7.0% at Week 26	Week 26	ITT population included all randomized participants. Missing data at Week 26 were assigned a status of nonresponder in the analysis.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group24

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	Sotagliflozin 400 mg	-0.7	Standard Error 0.1	percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26	Empagliflozin 25 mg	-0.8	Standard Error 0.1	percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26	Placebo	-0.3	Standard Error 0.1	percentage of HbA1c
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg	Sotagliflozin 400 mg	-5.6	Standard Error 1.3	mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg	Empagliflozin 25 mg	-6.7	Standard Error 1.3	mmHg
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg	Placebo	-3.5	Standard Error 1.5	mmHg
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Sotagliflozin 400 mg	-1.3	Standard Error 0.2	millimole per liter (mmol/L)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Empagliflozin 25 mg	-1.2	Standard Error 0.9	millimole per liter (mmol/L)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Placebo	-0.4	Standard Error 0.2	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 400 mg	-1.3	Standard Error 0.2	mmol/L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sotagliflozin 400 mg	307
Overall Study	STARTED	Empagliflozin 25 mg	309
Overall Study	STARTED	Placebo	154
Overall Study	COMPLETED	Sotagliflozin 400 mg	293
Overall Study	COMPLETED	Empagliflozin 25 mg	292
Overall Study	COMPLETED	Placebo	147
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	14
Overall Study	NOT COMPLETED	Empagliflozin 25 mg	17
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events147

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	Headache	Nervous system disorders	Sotagliflozin 400 mg	7	307
other	Headache	Nervous system disorders	Empagliflozin 25 mg	8	309
other	Headache	Nervous system disorders	Placebo	6	154
other	Constipation	Gastrointestinal disorders	Sotagliflozin 400 mg	3	307
other	Constipation	Gastrointestinal disorders	Empagliflozin 25 mg	5	309
other	Constipation	Gastrointestinal disorders	Placebo	6	154
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 400 mg	10	307
other	Diarrhoea	Gastrointestinal disorders	Empagliflozin 25 mg	8	309
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	154
other	Back pain	Musculoskeletal and connective tissue disorders	Sotagliflozin 400 mg	6	307

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sotagliflozin 400 mg	0	307
Total, all-cause mortality	Empagliflozin 25 mg	1	309
Total, all-cause mortality	Placebo	0	154
Total, other adverse events	Sotagliflozin 400 mg	58	307
Total, other adverse events	Empagliflozin 25 mg	68	309
Total, other adverse events	Placebo	39	154
Total, serious adverse events	Sotagliflozin 400 mg	10	307
Total, serious adverse events	Empagliflozin 25 mg	13	309
Total, serious adverse events	Placebo	9	154

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 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/NCT03351478

GET https://conductscience.org/api/trials/v1/NCT03351478/results?page=2

API reference For AI assistants