Trial · NCT03285594

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

NCT03285594, 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 Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents. Trials, record NCT03285594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03285594

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 Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
NCT number: NCT03285594
Status: Completed
Phases: Phase 3
Enrollment: 571 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: Sotagliflozin, Insulin glargine (HOE901), Placebo, Oral Antidiabetes Drugs (OADs)
First posted: 2017-09-18
Last updated: 2021-05-11
Other registries' IDs: eudract:2016-001804-43
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 18	Baseline and Week 18	An analysis of covariance (ANCOVA) model was used for the analysis.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	Baseline and Week 18	FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 18	Baseline and Week 18	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12	Baseline and Week 12	An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.
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	Change From Baseline in HbA1c at Week 52	Baseline and Week 52	An ANCOVA model was used for the analysis.
Secondary	Change From Baseline in Body Weight at Week 52	Baseline and Week 52	An ANCOVA model was used for the analysis.
Secondary	Percentage of Participants With Adverse Events (AEs)	First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks	An 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 this treatment.
Other	Percentage of Participants With Hypoglycemic Events	Up to 55.7 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

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 18	Baseline and Week 18	Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	Baseline and Week 18	ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.	milligram per deciliter (mg/dL)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 18	Baseline and Week 18	ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.	kilogram (kg)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12	Baseline and Week 12	Analysis population included 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 washout multiple imputation method 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 washout multiple imputation method under the missing not at random framework.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HbA1c at Week 52	Baseline and Week 52	ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 52	Baseline and Week 52	ITT population included all randomized participants irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout multiple imputation method under the missing not at random framework.	kg	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Adverse Events (AEs)	First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks	Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Percentage of Participants With Hypoglycemic Events	Up to 55.7 weeks	Safety population included all randomised participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered).	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group33

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 18	Placebo	-0.27	Standard Error 0.073	percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18	Sotagliflozin 200 mg	-0.72	Standard Error 0.073	percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18	Sotagliflozin 400 mg	-0.81	Standard Error 0.056	percentage of HbA1c
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	Placebo	12.882	Standard Error 3.6045	milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	Sotagliflozin 200 mg	-2.975	Standard Error 3.6083	milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	Sotagliflozin 400 mg	-8.949	Standard Error 2.7550	milligram per deciliter (mg/dL)
Change From Baseline in Body Weight at Week 18	Placebo	0.36	Standard Error 0.249	kilogram (kg)
Change From Baseline in Body Weight at Week 18	Sotagliflozin 200 mg	-0.73	Standard Error 0.250	kilogram (kg)
Change From Baseline in Body Weight at Week 18	Sotagliflozin 400 mg	-1.37	Standard Error 0.190	kilogram (kg)
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12	Placebo	-4.67	Standard Error 1.470	mmHg

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	144
Overall Study	STARTED	Sotagliflozin 200 mg	141
Overall Study	STARTED	Sotagliflozin 400 mg	286
Overall Study	Treated	Placebo	144
Overall Study	Treated	Sotagliflozin 200 mg	141
Overall Study	Treated	Sotagliflozin 400 mg	285
Overall Study	COMPLETED	Placebo	129
Overall Study	COMPLETED	Sotagliflozin 200 mg	130
Overall Study	COMPLETED	Sotagliflozin 400 mg	249
Overall Study	NOT COMPLETED	Placebo	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events240

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	Vitamin D deficiency	Metabolism and nutrition disorders	Placebo	9	144
other	Vitamin D deficiency	Metabolism and nutrition disorders	Sotagliflozin 200 mg	4	141
other	Vitamin D deficiency	Metabolism and nutrition disorders	Sotagliflozin 400 mg	10	285
other	Nasopharyngitis	Infections and infestations	Placebo	7	144
other	Nasopharyngitis	Infections and infestations	Sotagliflozin 200 mg	9	141
other	Nasopharyngitis	Infections and infestations	Sotagliflozin 400 mg	14	285
other	Upper respiratory tract infection	Infections and infestations	Placebo	8	144
other	Upper respiratory tract infection	Infections and infestations	Sotagliflozin 200 mg	1	141
other	Upper respiratory tract infection	Infections and infestations	Sotagliflozin 400 mg	14	285
other	Urinary tract infection	Infections and infestations	Placebo	8	144

1 to 10 of 240Source ClinicalTrials.gov

See all 240 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	144
Total, all-cause mortality	Sotagliflozin 200 mg	1	141
Total, all-cause mortality	Sotagliflozin 400 mg	6	285
Total, other adverse events	Placebo	30	144
Total, other adverse events	Sotagliflozin 200 mg	18	141
Total, other adverse events	Sotagliflozin 400 mg	45	285
Total, serious adverse events	Placebo	16	144
Total, serious adverse events	Sotagliflozin 200 mg	19	141
Total, serious adverse events	Sotagliflozin 400 mg	28	285

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/NCT03285594

GET https://conductscience.org/api/trials/v1/NCT03285594/results?page=2

API reference For AI assistants