Trial · NCT03242252

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

NCT03242252, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2021-06-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control. Trials, record NCT03242252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03242252

On this page

Trial

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

Title: Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
NCT number: NCT03242252
Status: Completed
Phases: Phase 3
Enrollment: 787 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3
Interventions: Placebo, Sotagliflozin
First posted: 2017-08-08
Last updated: 2021-06-25
Results first posted: 2021-06-25

Source ClinicalTrials.gov

Registered outcomes10

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	Baseline to Week 26	An Analysis of covariance (ANCOVA) model was used for analysis.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Baseline to Week 26	An ANCOVA model was used for analysis.
Secondary	Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12	Baseline to Week 12	An ANCOVA model was used for analysis.
Secondary	Change From Baseline in SBP at Week 12 for All Participants	Baseline to Week 12	An ANCOVA model was used for analysis.
Secondary	Change From Baseline in Body Weight at Week 26	Baseline to Week 26	An ANCOVA model was used for 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)	Up to 60 weeks
Other	Percentage of Participants With Hypoglycemic Events	Up to 60 weeks	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

Outcomes10

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	Baseline to Week 26	Intent-to-treat (ITT) population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.	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 or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts \& washout imputation method.	millimole per liter (mmol/L)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12	Baseline to Week 12	Analysis population included participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts \& washout imputation method.	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 or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts \& washout imputation method.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 26	Baseline to Week 26	ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using the retrieved dropouts \& washout imputation method.	kilogram (kg)	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 participants with baseline UACR \>30 mg/g in ITT population where, ITT population included all randomized participants or participants analyzed according to their randomized treatment. Missing data was imputed using control-based copy reference multiple imputation under the missing not at random framework.	percent change	GEOMETRIC_MEAN
SECONDARY	Percentage of Participants With HbA1c <6.5% at Week 26	Week 26	ITT population included all randomized participants or participants analyzed according to their randomized treatment.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7.0% at Week 26	Week 26	ITT population included all randomized participants or participants analyzed according to their randomized treatment.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to 60 weeks	Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Percentage of Participants With Hypoglycemic Events	Up to 60 weeks	Safety population included all participants who received at least 1 dose of study drug analyzed according to the treatment actually received.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group36

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	Placebo	-0.22	Standard Error 0.061	percentage of HbA1c
Change From Baseline in HbA1c at Week 26	Sotagliflozin 200 mg	-0.32	Standard Error 0.060	percentage of HbA1c
Change From Baseline in HbA1c at Week 26	Sotagliflozin 400 mg	-0.46	Standard Error 0.060	percentage of HbA1c
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Placebo	-0.374	Standard Error 0.1949	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 200 mg	-0.961	Standard Error 0.1715	millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	Sotagliflozin 400 mg	-0.852	Standard Error 0.1668	millimole per liter (mmol/L)
Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12	Placebo	-5.18	Standard Error 1.462	mmHg
Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12	Sotagliflozin 200 mg	-7.46	Standard Error 1.597	mmHg
Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12	Sotagliflozin 400 mg	-7.71	Standard Error 1.247	mmHg
Change From Baseline in SBP at Week 12 for All Participants	Placebo	-3.31	Standard Error 1.037	mmHg

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	260
Overall Study	STARTED	Sotagliflozin 200 mg	263
Overall Study	STARTED	Sotagliflozin 400 mg	264
Overall Study	COMPLETED	Placebo	224
Overall Study	COMPLETED	Sotagliflozin 200 mg	240
Overall Study	COMPLETED	Sotagliflozin 400 mg	232
Overall Study	NOT COMPLETED	Placebo	36
Overall Study	NOT COMPLETED	Sotagliflozin 200 mg	23
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	32

Source ClinicalTrials.gov

Adverse events375

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	13	260
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 200 mg	15	267
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin 400 mg	22	260
other	Vitamin D deficiency	Metabolism and nutrition disorders	Placebo	30	260
other	Vitamin D deficiency	Metabolism and nutrition disorders	Sotagliflozin 200 mg	24	267
other	Vitamin D deficiency	Metabolism and nutrition disorders	Sotagliflozin 400 mg	24	260
other	Nasopharyngitis	Infections and infestations	Placebo	13	260
other	Nasopharyngitis	Infections and infestations	Sotagliflozin 200 mg	7	267
other	Nasopharyngitis	Infections and infestations	Sotagliflozin 400 mg	12	260
other	Upper respiratory tract infection	Infections and infestations	Placebo	18	260

1 to 10 of 375Source ClinicalTrials.gov

See all 375 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	3	260
Total, all-cause mortality	Sotagliflozin 200 mg	2	267
Total, all-cause mortality	Sotagliflozin 400 mg	5	260
Total, other adverse events	Placebo	80	260
Total, other adverse events	Sotagliflozin 200 mg	72	267
Total, other adverse events	Sotagliflozin 400 mg	77	260
Total, serious adverse events	Placebo	48	260
Total, serious adverse events	Sotagliflozin 200 mg	43	267
Total, serious adverse events	Sotagliflozin 400 mg	44	260

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36782093	DERIVED

Source 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/NCT03242252

GET https://conductscience.org/api/trials/v1/NCT03242252/results?page=2

API reference For AI assistants