Trial · NCT01742208
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
NCT01742208, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2019-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus. Trials, record NCT01742208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01742208
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
- NCT number
- NCT01742208
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Sotagliflozin, Placebo, Sotagliflozin
- First posted
- 2012-12-05
- Last updated
- 2020-02-12
- Results first posted
- 2019-10-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Baseline, Day 3 to Day 27 | Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean. |
| Secondary | Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Baseline, Day 3 to Day 27 | Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\] / number of assessments)/baseline over Days 3 to 27. Percent change was calculated and is presented separately for each meal: i.e., breakfast, lunch and dinner. LS Means and CI for the Expansion groups were based on an ANCOVA model . LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean. |
| Secondary | Percent Change From Baseline in Total Daily Amount of Exogenous Insulin (Total Daily Bolus + Total Daily Basal) Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Baseline, Day 3 to Day 27 | Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/ number of assessments)/baseline over Days 3 to 27. LS Means and CI for the Expansion groups were based on an ANCOVA model. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29 | Baseline, Day 29 | Baseline was defined as the last non-missing assessment prior to first dose of study drug. Change in FPG was calculated by subtracting baseline value from Day 29 value. LS Means and CI for the Expansion groups were based on a linear mixed repeated measures model. |
| Secondary | Change From Day 1 in 3-hour Plasma Glucose AUC (AUC0-3 h) Following a Mixed Meal Tolerance Test (MMTT) at Day 29: Expansion Groups | Prior to start of mixed meal and 30, 60, 90, 120 and 180 min post start of mixed meal, on Day 1 and Day 29 | A MMTT with frequent blood sample collection and with urine collection was performed on Day 1 and Day 29. Participants fasted (with the exception of water or non-caffeinated, calorie-free beverages) for at least 8 hours before the start of the MMTT and until the final blood sample was collected. Study drug was to be given within 15 minutes before liquid "Boost® Original" breakfast. The area under the plasma concentration-time curve (AUC) from time-zero to 3h postdose on Day 1 and Day 29 was calculated using the linear-up/log-down trapezoidal rule. Change was calculated by subtracting Day 1 value from Day 29 value. LS Means and CI were based on a linear mixed model. |
| Secondary | Change From Baseline in Percent Time Per Day Spent in Euglycemic Range (>=70 and <=180 mg/dL) Over Days 3 to 27 (Treatment Outpatient Period) Based on Continuous Glucose Monitoring | Baseline, Day 3 to Day 27 | Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Change in percent time per day spent in euglycemic range was calculated by subtracting baseline value from Day 29 value. LS Means and CI for the Expansion groups were based on a mixed model. LS mean and CI for the Pioneer Group were based on the arithmetic treatment mean. |
| Secondary | Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups | From 15 minutes before start of mixed meal until 180 min post start of mixed meal, on Day 1 and Day 29 | A MMTT with frequent blood sample collection and with urine collection was performed on Day 1 and Day 29. Participants fasted (with the exception of water or non-caffeinated, calorie-free beverages) for at least 8 hours before the start of the MMTT and until the final blood sample was collected. Study drug was to be given within 15 minutes before liquid "Boost® Original" breakfast. Participants were asked to void immediately before blood sample 15 minutes before start of mixed meal and immediately after the 180-minute (3 hour) blood sample was collected, and all urine between the -15 minute and post-180-minute time points was collected for urine glucose calculation. Change was calculated by subtracting Day 1 value from Day 29 value. LS Means were based on a linear mixed model. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Baseline, Day 3 to Day 27 | Analysis was performed using ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Baseline, Day 3 to Day 27 | Analysis was performed using ITT population. Here, number analyzed=participants with available data for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Daily Amount of Exogenous Insulin (Total Daily Bolus + Total Daily Basal) Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Baseline, Day 3 to Day 27 | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29 | Baseline, Day 29 | Analysis was performed on ITT population. | milligram/deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Day 1 in 3-hour Plasma Glucose AUC (AUC0-3 h) Following a Mixed Meal Tolerance Test (MMTT) at Day 29: Expansion Groups | Prior to start of mixed meal and 30, 60, 90, 120 and 180 min post start of mixed meal, on Day 1 and Day 29 | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. Data for this outcome measure was not analyzed for Pioneer Group participants. | mg*h/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent Time Per Day Spent in Euglycemic Range (>=70 and <=180 mg/dL) Over Days 3 to 27 (Treatment Outpatient Period) Based on Continuous Glucose Monitoring | Baseline, Day 3 to Day 27 | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. | percent time per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups | From 15 minutes before start of mixed meal until 180 min post start of mixed meal, on Day 1 and Day 29 | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. Data for this outcome measure was not analyzed for Pioneer Group participants. | gram per 3 hour | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Pioneer Group | -46.32 | 95% Confidence Interval -99.71 to 7.06 | percent change | |
| Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Placebo - Expansion Group | -7.00 | 95% Confidence Interval -19.18 to 5.17 | percent change | |
| Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Expansion Group | -32.14 | 95% Confidence Interval -45.09 to -19.18 | percent change | |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Pioneer Group | Before Breakfast | -42.19 | 95% Confidence Interval -169.85 to 85.46 | percent change |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Placebo - Expansion Group | Before Breakfast | 10.79 | 95% Confidence Interval -13.28 to 34.86 | percent change |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Expansion Group | Before Breakfast | -25.16 | 95% Confidence Interval -51.15 to 0.82 | percent change |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Pioneer Group | Before Lunch | -59.02 | 95% Confidence Interval -109.11 to -8.93 | percent change |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Placebo - Expansion Group | Before Lunch | 3.94 | 95% Confidence Interval -19.33 to 27.20 | percent change |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Expansion Group | Before Lunch | -25.85 | 95% Confidence Interval -50.59 to -1.12 | percent change |
| Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) | Sotagliflozin 400 mg - Pioneer Group | Before Dinner | -34.83 | 95% Confidence Interval -129.08 to 59.42 | percent change |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sotagliflozin 400 mg - Pioneer Group | 3 | |
| Overall Study | STARTED | Placebo - Expansion Group | 17 | |
| Overall Study | STARTED | Sotagliflozin 400 mg - Expansion Group | 16 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg - Pioneer Group | 3 | |
| Overall Study | COMPLETED | Placebo - Expansion Group | 17 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg - Expansion Group | 16 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 400 mg - Pioneer Group | 0 | |
| Overall Study | NOT COMPLETED | Placebo - Expansion Group | 0 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 400 mg - Expansion Group | 0 |
Source ClinicalTrials.gov
Adverse events141
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 | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Sotagliflozin 400 mg - Pioneer Group | 0 | 3 | 0 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Placebo - Expansion Group | 0 | 17 | 0 |
| other | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | Sotagliflozin 400 mg - Expansion Group | 1 | 16 | 1 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Sotagliflozin 400 mg - Pioneer Group | 0 | 3 | 0 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Placebo - Expansion Group | 0 | 17 | 0 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Sotagliflozin 400 mg - Expansion Group | 1 | 16 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Sotagliflozin 400 mg - Pioneer Group | 0 | 3 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo - Expansion Group | 0 | 17 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Sotagliflozin 400 mg - Expansion Group | 1 | 16 | 1 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Sotagliflozin 400 mg - Pioneer Group | 0 | 3 | 0 |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotagliflozin 400 mg - Pioneer Group | 0 | 3 |
| Total, all-cause mortality | Placebo - Expansion Group | 0 | 17 |
| Total, all-cause mortality | Sotagliflozin 400 mg - Expansion Group | 0 | 16 |
| Total, other adverse events | Sotagliflozin 400 mg - Pioneer Group | 1 | 3 |
| Total, other adverse events | Placebo - Expansion Group | 12 | 17 |
| Total, other adverse events | Sotagliflozin 400 mg - Expansion Group | 14 | 16 |
| Total, serious adverse events | Sotagliflozin 400 mg - Pioneer Group | 0 | 3 |
| Total, serious adverse events | Placebo - Expansion Group | 0 | 17 |
| Total, serious adverse events | Sotagliflozin 400 mg - Expansion Group | 2 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26049551 | DERIVED |
Source PubMed
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/NCT01742208
GET https://conductscience.org/api/trials/v1/NCT01742208/results?page=2