Trial · NCT02384941
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
NCT02384941, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2019-11-25
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 NCT02384941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02384941
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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
- NCT02384941
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 793 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Placebo, Sotagliflozin
- First posted
- 2015-03-10
- Last updated
- 2020-02-12
- Results first posted
- 2019-11-25
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 lower 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) Upto Week 24 | Baseline to Week 24 | Blood samples were collected for the assessment of Hemoglobin A1C to determine the participants with A1C value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis. |
| Secondary | Absolute 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 per 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 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 at Week 24 compared to baseline. |
| Secondary | Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24 | Baseline to Week 24 | DTSQs is a diabetes-specific measure used to evaluate overall treatment satisfaction and perception of hyperglycemia and hypoglycemia events. It consists of 8 items and the response categories for all items were on a 7-point likert scale.The DTSQs response options ranged from 0 (very dissatisfied) to 6 (very satisfied). Responses to item 1, 4, 5, 6, 7 and 8 were summarized to determine the total treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied), with a higher score corresponding to higher satisfaction . 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 Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24 | Baseline to Week 24 | The DDS2 is a 2-item diabetes distress screening instrument where respondents rated, on a 6-point scale, 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 (not a problem) to 12 (very serious problem), with higher score corresponding to higher distress. 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 | Modified intent to treat (mITT) analysis set included all randomly assigned participants who have taken at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signified 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) Upto Week 24 | Baseline to Week 24 | Analysis performed on mITT analysis set. | percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in Body Weight at Week 24 | Baseline to Week 24 | Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified 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 performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified 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 performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure. | millimole per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24 | Baseline to Week 24 | Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24 | Baseline to Week 24 | Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Body Weight at Week 24 | Baseline to Week 24 | Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified 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 | -0.07 | Standard Error 0.036 | percentage of A1C | |
| Change From Baseline in A1C at Week 24 | Sotagliflozin 200 mg | -0.43 | Standard Error 0.036 | percentage of A1C | |
| Change From Baseline in A1C at Week 24 | Sotagliflozin 400 mg | -0.48 | Standard Error 0.036 | 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) Upto Week 24 | Placebo | 21.6 | 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) Upto Week 24 | Sotagliflozin 200 mg | 33.5 | 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) Upto Week 24 | Sotagliflozin 400 mg | 43.5 | percentage of participants | ||
| Absolute Change From Baseline in Body Weight at Week 24 | Placebo | 0.78 | Standard Error 0.187 | kilograms (kg) | |
| Absolute Change From Baseline in Body Weight at Week 24 | Sotagliflozin 200 mg | -1.57 | Standard Error 0.188 | kilograms (kg) | |
| Absolute Change From Baseline in Body Weight at Week 24 | Sotagliflozin 400 mg | -2.67 | Standard Error 0.188 | kilograms (kg) | |
| Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24 | Placebo | -0.84 | Standard Error 0.688 | IU/day |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 268 | |
| Overall Study | STARTED | Sotagliflozin 200 mg | 263 | |
| Overall Study | STARTED | Sotagliflozin 400 mg | 262 | |
| Overall Study | COMPLETED | Placebo | 218 | |
| Overall Study | COMPLETED | Sotagliflozin 200 mg | 228 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg | 221 | |
| Overall Study | NOT COMPLETED | Placebo | 50 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 200 mg | 35 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 400 mg | 41 |
Source ClinicalTrials.gov
Adverse 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 | Blood ketone body increased | Investigations | Placebo | 2 | 268 | 2 |
| other | Blood ketone body increased | Investigations | Sotagliflozin 200 mg | 10 | 263 | 20 |
| other | Blood ketone body increased | Investigations | Sotagliflozin 400 mg | 14 | 262 | 19 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 10 | 268 | 13 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sotagliflozin 200 mg | 6 | 263 | 6 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sotagliflozin 400 mg | 18 | 262 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 19 | 268 | 21 |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 200 mg | 22 | 263 | 26 |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 400 mg | 29 | 262 | 41 |
| other | Nausea | Gastrointestinal disorders | Placebo | 18 | 268 | 21 |
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 | 1 | 268 |
| Total, all-cause mortality | Sotagliflozin 200 mg | 0 | 263 |
| Total, all-cause mortality | Sotagliflozin 400 mg | 0 | 262 |
| Total, other adverse events | Placebo | 129 | 268 |
| Total, other adverse events | Sotagliflozin 200 mg | 132 | 263 |
| Total, other adverse events | Sotagliflozin 400 mg | 130 | 262 |
| Total, serious adverse events | Placebo | 20 | 268 |
| Total, serious adverse events | Sotagliflozin 200 mg | 27 | 263 |
| Total, serious adverse events | Sotagliflozin 400 mg | 29 | 262 |
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/NCT02384941
GET https://conductscience.org/api/trials/v1/NCT02384941/results?page=2