Trial · NCT02421510
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
NCT02421510, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2019-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy. Trials, record NCT02421510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02421510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
- NCT number
- NCT02421510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 782 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Sotagliflozin, Sotagliflozin, Placebo
- First posted
- 2015-04-20
- Last updated
- 2020-02-12
- Other registries' IDs
- eudract:2014-005153-39
- Results first posted
- 2019-10-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in A1C at Week 24 | Baseline to Week 24 | Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement. |
| Secondary | Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24 | Baseline to Week 24 | The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0% and a central blinded adjudication process to determine whether participants experienced either DKA or severe hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis. |
| Secondary | Change From Baseline in Body Weight at Week 24 | Baseline to Week 24 | Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from baseline indicates a loss in body weight from baseline to Week 24. |
| Secondary | Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24 | Baseline to Week 24 | The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicated a reduction in the amount of bolus insulin used and a positive change from baseline indicated an increase in the amount of bolus insulin used between baseline and Week 24. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline to Week 24 | The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline. |
| Secondary | Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24 | Baseline to Week 24 | The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. The baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement. |
| Secondary | Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24 | Baseline to Week 24 | DDS2 is a 2-item diabetes distress screening instrument where participants rated the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement. |
| Secondary | Percent Change From Baseline in Body Weight at Week 24 | Baseline to Week 24 | Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24. |
Source ClinicalTrials.gov
Outcomes8
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 A1C at Week 24 | Baseline to Week 24 | Analysis included participants from the modified intent to treat (mITT) population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Percentage of A1C | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight at Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | IU/day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Milligram per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Body Weight at Week 24 | Baseline to Week 24 | Analysis included participants from the mITT population, including all available post baseline values. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
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 A1C at Week 24 | Placebo | -0.02 | Standard Error 0.044 | Percentage of A1C | |
| Change From Baseline in A1C at Week 24 | Sotagliflozin 200 mg | -0.39 | Standard Error 0.044 | Percentage of A1C | |
| Change From Baseline in A1C at Week 24 | Sotagliflozin 400 mg | -0.37 | Standard Error 0.043 | Percentage of A1C | |
| Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24 | Placebo | 15.1 | Percentage of participants | ||
| Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24 | Sotagliflozin 200 mg | 31.4 | Percentage of participants | ||
| Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24 | Sotagliflozin 400 mg | 32.3 | Percentage of participants | ||
| Change From Baseline in Body Weight at Week 24 | Placebo | 0.11 | Standard Error 0.201 | Kilograms (kg) | |
| Change From Baseline in Body Weight at Week 24 | Sotagliflozin 200 mg | -1.88 | Standard Error 0.200 | Kilograms (kg) | |
| Change From Baseline in Body Weight at Week 24 | Sotagliflozin 400 mg | -2.47 | Standard Error 0.199 | Kilograms (kg) | |
| Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24 | Placebo | -1.19 | Standard Error 0.635 | IU/day |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 258 | |
| Overall Study | STARTED | Sotagliflozin 200 mg | 261 | |
| Overall Study | STARTED | Sotagliflozin 400 mg | 263 | |
| Overall Study | Completed the 24 Week Treatment Period | Placebo | 236 | |
| Overall Study | Completed the 24 Week Treatment Period | Sotagliflozin 200 mg | 239 | |
| Overall Study | Completed the 24 Week Treatment Period | Sotagliflozin 400 mg | 240 | |
| Overall Study | COMPLETED | Placebo | 225 | |
| Overall Study | COMPLETED | Sotagliflozin 200 mg | 226 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg | 227 | |
| Overall Study | NOT COMPLETED | Placebo | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events174
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 | 10 | 258 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 200 mg | 12 | 261 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 400 mg | 20 | 263 | 29 |
| other | Viral upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Placebo | 40 | 258 | 58 |
| other | Viral upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Sotagliflozin 200 mg | 44 | 261 | 60 |
| other | Viral upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Sotagliflozin 400 mg | 49 | 263 | 70 |
| serious | Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 258 | 1 |
| serious | Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sotagliflozin 200 mg | 1 | 261 | 1 |
| serious | Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sotagliflozin 400 mg | 0 | 263 | 0 |
| serious | Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 258 | 1 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 2 | 258 |
| Total, all-cause mortality | Sotagliflozin 200 mg | 0 | 261 |
| Total, all-cause mortality | Sotagliflozin 400 mg | 0 | 263 |
| Total, other adverse events | Placebo | 46 | 258 |
| Total, other adverse events | Sotagliflozin 200 mg | 52 | 261 |
| Total, other adverse events | Sotagliflozin 400 mg | 64 | 263 |
| Total, serious adverse events | Placebo | 17 | 258 |
| Total, serious adverse events | Sotagliflozin 200 mg | 26 | 261 |
| Total, serious adverse events | Sotagliflozin 400 mg | 21 | 263 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT02421510
GET https://conductscience.org/api/trials/v1/NCT02421510/results?page=2