Trial · NCT02926950

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

NCT02926950, 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 Patients With Type 2 Diabetes Mellitus on Background of Metformin. Trials, record NCT02926950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02926950

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 in Patients With Type 2 Diabetes Mellitus on Background of Metformin
NCT number: NCT02926950
Status: Completed
Phases: Phase 3
Enrollment: 518 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: Sotagliflozin (SAR439954), Placebo, Metformin
First posted: 2016-10-06
Last updated: 2021-05-11
Other registries' IDs: eudract:2016-001800-49
Results first posted: 2021-05-11

Source ClinicalTrials.gov

Registered outcomes9

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 and Week 26	An analysis of covariance (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 and Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline and Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 26	Baseline and Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 mmHg	Baseline and Week 12	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in SBP at Week 12 for All Participants	Baseline and 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
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

Outcomes9

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 and Week 26	Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using the retrieved dropouts and washout imputation method.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Baseline and Week 26	ITT population included all randomized participants. Missing data are imputed using control-based copy reference multiple imputation method.	millimole per liter (mmol/L)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline and Week 26	ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts and washout imputation method.	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 26	Baseline and Week 26	ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts and washout imputation method.	kilogram (kg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 mmHg	Baseline and Week 12	Analysis was performed on ITT population in participant with baseline SBP ≥130 mmHg. Missing data was imputed using control-based copy reference multiple imputation method.	millimeter of mercury (mmHg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in SBP at Week 12 for All Participants	Baseline and Week 12	ITT population included all randomized participants. Missing data was imputed using control-based copy reference multiple 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.	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 group22

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 + Metformin	-0.29	Standard Error 0.079	percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	Sotagliflozin 400 mg + Metformin	-0.77	Standard Error 0.077	percentage of HbA1c
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Placebo + Metformin	-0.930	Standard Error 0.2353	millimole per liter (mmol/L)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26	Sotagliflozin 400 mg + Metformin	-2.502	Standard Error 0.2292	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Placebo + Metformin	-0.550	Standard Error 0.1864	mmol/L
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 400 mg + Metformin	-1.310	Standard Error 0.2089	mmol/L
Change From Baseline in Body Weight at Week 26	Placebo + Metformin	-0.69	Standard Error 0.310	kilogram (kg)
Change From Baseline in Body Weight at Week 26	Sotagliflozin 400 mg + Metformin	-2.56	Standard Error 0.331	kilogram (kg)
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 mmHg	Placebo + Metformin	-6.92	Standard Error 1.233	millimeter of mercury (mmHg)
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 mmHg	Sotagliflozin 400 mg + Metformin	-10.21	Standard Error 1.270	millimeter of mercury (mmHg)

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo + Metformin	259
Overall Study	STARTED	Sotagliflozin 400 mg + Metformin	259
Overall Study	COMPLETED	Placebo + Metformin	210
Overall Study	COMPLETED	Sotagliflozin 400 mg + Metformin	211
Overall Study	NOT COMPLETED	Placebo + Metformin	49
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg + Metformin	48

Source ClinicalTrials.gov

Adverse events134

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	Hypertension	Vascular disorders	Placebo + Metformin	13	259
other	Hypertension	Vascular disorders	Sotagliflozin 400 mg + Metformin	3	259
other	Headache	Nervous system disorders	Placebo + Metformin	15	259
other	Headache	Nervous system disorders	Sotagliflozin 400 mg + Metformin	6	259
other	Diarrhoea	Gastrointestinal disorders	Placebo + Metformin	11	259
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 400 mg + Metformin	22	259
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo + Metformin	19	259
other	Back pain	Musculoskeletal and connective tissue disorders	Sotagliflozin 400 mg + Metformin	8	259
other	Vitamin D deficiency	Metabolism and nutrition disorders	Placebo + Metformin	19	259
other	Vitamin D deficiency	Metabolism and nutrition disorders	Sotagliflozin 400 mg + Metformin	14	259

1 to 10 of 134Source ClinicalTrials.gov

See all 134 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Metformin	1	259
Total, all-cause mortality	Sotagliflozin 400 mg + Metformin	3	259
Total, other adverse events	Placebo + Metformin	109	259
Total, other adverse events	Sotagliflozin 400 mg + Metformin	85	259
Total, serious adverse events	Placebo + Metformin	23	259
Total, serious adverse events	Sotagliflozin 400 mg + Metformin	19	259

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
Placebo + Metformin vs Sotagliflozin 400 mg + Metformin: deaths from any cause	Trial comparisons
Placebo + Metformin vs Sotagliflozin 400 mg + Metformin: 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/NCT02926950

GET https://conductscience.org/api/trials/v1/NCT02926950/results?page=2

API reference For AI assistants