Trial · NCT03386344
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
NCT03386344, Phase 3, Terminated, Lexicon Pharmaceuticals; results first posted 2021-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control. Trials, record NCT03386344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03386344
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- NCT number
- NCT03386344
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 376 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sotagliflozin, Placebo
- First posted
- 2017-12-29
- Last updated
- 2021-06-25
- Results first posted
- 2021-06-25
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 to Week 26 | An analysis of covariance (ANCOVA) model is used for analysis. |
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | Baseline to Week 26 | An ANCOVA model is used for analysis. |
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 | Baseline to Week 26 | An ANCOVA model is used for analysis. |
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26 | Baseline to Week 26 | An ANCOVA model is used for analysis. |
| Secondary | Change From Baseline in Body Weight at Week 26 | Baseline to Week 26 | An ANCOVA model is used for analysis. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Baseline to Week 26 | An ANCOVA model is used for analysis. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | Baseline to Week 12 | An ANCOVA model is used for analysis. |
| Secondary | Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26 | Week 26 | |
| Secondary | Percentage of Participants With Adverse Events (AEs) | up to 106 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. |
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 to Week 26 | Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | Baseline to Week 26 | Safety population included all randomized participants who had received at least one dose of investigational medicinal product (IMP). Missing data are imputed using a pattern-based imputation method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 | Baseline to Week 26 | Safety population included all randomized participants who had received at least one dose of IMP. Missing data are imputed using a pattern-based imputation method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26 | Baseline to Week 26 | Safety population included all randomized participants who had received at least one dose of IMP. Missing data are imputed using a pattern-based imputation method. | percent change | 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 are imputed using washout imputation method under the missing not at random framework. | kilogram (kg) | 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 are imputed using washout imputation method under the missing not at random framework. | milligram per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | 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 imputation method under the missing not at random framework. | millimeter of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hemoglobin A1c (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 Adverse Events (AEs) | up to 106 weeks | Safety population included all randomized participants who had received at least one dose of IMP. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
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 | Placebo | -0.22 | Standard Error 0.080 | percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 | Sotagliflozin 200 mg | -0.66 | Standard Error 0.077 | percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 | Sotagliflozin 400 mg | -0.67 | Standard Error 0.079 | percentage of HbA1c | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | Placebo | 0.37 | Standard Error 0.327 | percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | Sotagliflozin 200 mg | 0.13 | Standard Error 0.323 | percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | Sotagliflozin 400 mg | 0.22 | Standard Error 0.327 | percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 | Placebo | -0.36 | Standard Error 0.259 | percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 | Sotagliflozin 200 mg | -0.22 | Standard Error 0.220 | percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 | Sotagliflozin 400 mg | -0.16 | Standard Error 0.223 | percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26 | Placebo | -0.94 | Standard Error 0.379 | percent change |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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 | 126 | |
| Overall Study | STARTED | Sotagliflozin 200 mg | 125 | |
| Overall Study | STARTED | Sotagliflozin 400 mg | 125 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | COMPLETED | Sotagliflozin 200 mg | 9 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 117 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 200 mg | 116 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 400 mg | 116 |
Source ClinicalTrials.gov
Adverse events195
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 | 7 | 125 | |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 200 mg | 6 | 125 | |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 400 mg | 16 | 125 | |
| other | Influenza | Infections and infestations | Placebo | 2 | 125 | |
| other | Influenza | Infections and infestations | Sotagliflozin 200 mg | 11 | 125 | |
| other | Influenza | Infections and infestations | Sotagliflozin 400 mg | 5 | 125 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 12 | 125 | |
| other | Nasopharyngitis | Infections and infestations | Sotagliflozin 200 mg | 9 | 125 | |
| other | Nasopharyngitis | Infections and infestations | Sotagliflozin 400 mg | 11 | 125 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 24 | 125 |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 125 |
| Total, all-cause mortality | Sotagliflozin 200 mg | 0 | 125 |
| Total, all-cause mortality | Sotagliflozin 400 mg | 0 | 125 |
| Total, other adverse events | Placebo | 66 | 125 |
| Total, other adverse events | Sotagliflozin 200 mg | 67 | 125 |
| Total, other adverse events | Sotagliflozin 400 mg | 68 | 125 |
| Total, serious adverse events | Placebo | 20 | 125 |
| Total, serious adverse events | Sotagliflozin 200 mg | 10 | 125 |
| Total, serious adverse events | Sotagliflozin 400 mg | 9 | 125 |
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/NCT03386344
GET https://conductscience.org/api/trials/v1/NCT03386344/results?page=2