Trial · NCT03242018

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

NCT03242018, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2021-06-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control. Trials, record NCT03242018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03242018

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Trial

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

Title: A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
NCT number: NCT03242018
Status: Completed
Phases: Phase 3
Enrollment: 277 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
Interventions: Placebo, Sotagliflozin
First posted: 2017-08-08
Last updated: 2021-06-25
Results first posted: 2021-06-25

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo	Baseline to Week 26	An analysis of covariance (ANCOVA) model was used for the analysis.
Secondary	Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo	Baseline to Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline to Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 26	Baseline to Week 26	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg	Baseline to Week 12	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in SBP at Week 12 for All Participants	Baseline to Week 12	An ANCOVA model was used for the analysis.
Secondary	Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)	Baseline to Week 26	An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
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
Secondary	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks	An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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 HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo	Baseline to Week 26	Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo	Baseline to Week 26	ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.	percentage of 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, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.	millimole per liter (mmol/L)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 26	Baseline to Week 26	ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.	kilogram (kg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg	Baseline to Week 12	Analysis population included all participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.	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, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)	Baseline to Week 26	Analysis population included all participants with baseline UACR \> 30 mg/g in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method.	percent change	GEOMETRIC_MEAN
SECONDARY	Percentage of Participants With HbA1c <6.5% at Week 26	Week 26	ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7.0% at Week 26	Week 26	ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks	Safety population included all randomized participants who received at least one dose of double-blind IMP. Two participants were randomized to Sotagliflozin 400 mg and dosed with Sotagliflozin 200 mg and 400 mg treatments during the study. Data for these participants were summarized in the Sotagliflozin 200 mg arm in the safety population.	percentage of participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group37

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

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo	Placebo	-0.11	Standard Error 0.151	percentage of HbA1c
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo	Sotagliflozin 400 mg	-0.40	Standard Error 0.131	percentage of HbA1c
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo	Placebo	-0.11	Standard Error 0.151	percentage of HbA1c
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo	Sotagliflozin 200 mg	-0.07	Standard Error 0.162	percentage of HbA1c
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Placebo	0.069	Standard Error 0.4482	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 200 mg	-0.291	Standard Error 0.5056	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 400 mg	-0.644	Standard Error 0.4348	millimole per liter (mmol/L)
Change From Baseline in Body Weight at Week 26	Placebo	0.39	Standard Error 0.615	kilogram (kg)
Change From Baseline in Body Weight at Week 26	Sotagliflozin 200 mg	-0.43	Standard Error 0.480	kilogram (kg)
Change From Baseline in Body Weight at Week 26	Sotagliflozin 400 mg	-1.02	Standard Error 0.490	kilogram (kg)

1 to 10 of 37Source ClinicalTrials.gov

See all 37 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	93
Overall Study	STARTED	Sotagliflozin 200 mg	92
Overall Study	STARTED	Sotagliflozin 400 mg	92
Overall Study	COMPLETED	Placebo	75
Overall Study	COMPLETED	Sotagliflozin 200 mg	78
Overall Study	COMPLETED	Sotagliflozin 400 mg	78
Overall Study	NOT COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	Sotagliflozin 200 mg	14
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	14

Source ClinicalTrials.gov

Adverse events258

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	5	93
other	Hypertension	Vascular disorders	Sotagliflozin 200 mg	1	94
other	Hypertension	Vascular disorders	Sotagliflozin 400 mg	3	90
other	Glomerular filtration rate decreased	Investigations	Placebo	3	93
other	Glomerular filtration rate decreased	Investigations	Sotagliflozin 200 mg	10	94
other	Glomerular filtration rate decreased	Investigations	Sotagliflozin 400 mg	8	90
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	93
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 200 mg	5	94
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 400 mg	5	90
other	Renal impairment	Renal and urinary disorders	Placebo	7	93

1 to 10 of 258Source ClinicalTrials.gov

See all 258 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	6	93
Total, all-cause mortality	Sotagliflozin 200 mg	6	94
Total, all-cause mortality	Sotagliflozin 400 mg	3	90
Total, other adverse events	Placebo	44	93
Total, other adverse events	Sotagliflozin 200 mg	44	94
Total, other adverse events	Sotagliflozin 400 mg	29	90
Total, serious adverse events	Placebo	21	93
Total, serious adverse events	Sotagliflozin 200 mg	18	94
Total, serious adverse events	Sotagliflozin 400 mg	20	90

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34338408	DERIVED	PubMed
38770818	DERIVED	PubMed

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/NCT03242018

GET https://conductscience.org/api/trials/v1/NCT03242018/results?page=2

API reference For AI assistants