Trial · NCT02926937
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy
NCT02926937, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2021-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy. Trials, record NCT02926937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02926937
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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 Not Currently Treated With Antidiabetic Therapy
- NCT number
- NCT02926937
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 399 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sotagliflozin (SAR439954), Placebo
- First posted
- 2016-10-06
- Last updated
- 2021-06-21
- Other registries' IDs
- eudract:2016-001799-31
- Results first posted
- 2021-06-21
Source ClinicalTrials.gov
Registered outcomes14
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 (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 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (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 (Sotagliflozin 400 mg Versus Placebo) | Baseline to 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 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Week 26 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the Intent-to-treat (ITT) population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are 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 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1.Missing data are imputed using washout imputation method under the missing not at random framework. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | Analysis was performed on participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1 with Baseline SBP ≥130 mmHg. Missing data are imputed using washout imputation method under the missing not at random framework. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout 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 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 12 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | kilogram (Kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Placebo | -0.34 | Standard Error 0.120 | percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Sotagliflozin 400 mg | -1.03 | Standard Error 0.122 | percentage of HbA1c | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Placebo | -0.591 | Standard Error 0.1943 | millimole per liter (mmol/L) | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Sotagliflozin 400 mg | -1.156 | Standard Error 0.1964 | millimole per liter (mmol/L) | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Placebo | -0.500 | Standard Error 0.2443 | mmol/L | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Sotagliflozin 200 mg | -0.847 | Standard Error 0.2477 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Placebo | -0.201 | Standard Error 0.2739 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Sotagliflozin 400 mg | -1.756 | Standard Error 0.2719 | mmol/L | |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) | Placebo | -4.45 | Standard Error 2.419 | mmHg | |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) | Sotagliflozin 400 mg | -7.96 | Standard Error 2.282 | mmHg |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 150 | |
| Overall Study | STARTED | Sotagliflozin 400 mg | 142 | |
| Overall Study | STARTED | Sotagliflozin 200 mg | 107 | |
| Overall Study | COMPLETED | Placebo | 131 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg | 127 | |
| Overall Study | COMPLETED | Sotagliflozin 200 mg | 96 | |
| Overall Study | NOT COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 400 mg | 15 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 200 mg | 11 |
Source ClinicalTrials.gov
Adverse events45
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 150 | |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 400 mg | 9 | 142 | |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 200 mg | 5 | 107 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 7 | 150 | |
| other | Urinary tract infection | Infections and infestations | Sotagliflozin 400 mg | 8 | 142 | |
| other | Urinary tract infection | Infections and infestations | Sotagliflozin 200 mg | 3 | 107 | |
| other | Headache | Nervous system disorders | Placebo | 9 | 150 | |
| other | Headache | Nervous system disorders | Sotagliflozin 400 mg | 4 | 142 | |
| other | Headache | Nervous system disorders | Sotagliflozin 200 mg | 7 | 107 | |
| serious | Retinal detachment | Eye disorders | Placebo | 0 | 150 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 150 |
| Total, all-cause mortality | Sotagliflozin 400 mg | 0 | 142 |
| Total, all-cause mortality | Sotagliflozin 200 mg | 0 | 107 |
| Total, other adverse events | Placebo | 20 | 150 |
| Total, other adverse events | Sotagliflozin 400 mg | 17 | 142 |
| Total, other adverse events | Sotagliflozin 200 mg | 14 | 107 |
| Total, serious adverse events | Placebo | 3 | 150 |
| Total, serious adverse events | Sotagliflozin 400 mg | 3 | 142 |
| Total, serious adverse events | Sotagliflozin 200 mg | 2 | 107 |
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.
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/NCT02926937
GET https://conductscience.org/api/trials/v1/NCT02926937/results?page=2