Trial · NCT02531035
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
NCT02531035, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2019-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone. Trials, record NCT02531035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02531035
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
- NCT number
- NCT02531035
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,405 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
- Interventions
- Sotagliflozin, Placebo
- First posted
- 2015-08-21
- Last updated
- 2020-02-12
- Results first posted
- 2019-11-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization | Week 24 | The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia. |
| Secondary | Change From Baseline in A1C | Baseline to Week 24 | Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement. |
| Secondary | Absolute Change From Baseline in Body Weight | 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 Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) | Baseline to Week 16 | An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16. |
| Secondary | Percent Change From Baseline in Mean Daily Bolus Insulin Dose | 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 percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization | Week 24 | The primary efficacy analyses were based on the modified Intent-to-Treat (mITT) population. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in A1C | Baseline to Week 24 | Analyses included participants from the mITT population. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percentage of A1c | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Body Weight | Baseline to Week 24 | Analyses included participants from the mITT population. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) | Baseline to Week 16 | Participants from mITT population and who had a Baseline SBP \>= 130 mm Hg. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Mean Daily Bolus Insulin Dose | Baseline to Week 24 | Analyses included participants from the mITT population. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change in IU/day | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization | Placebo | 15.2 | 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) After Randomization | Sotagliflozin 400 mg | 28.6 | percentage of participants | ||
| Change From Baseline in A1C | Placebo | -0.33 | Standard Error 0.031 | percentage of A1c | |
| Change From Baseline in A1C | Sotagliflozin 400 mg | -0.79 | Standard Error 0.032 | percentage of A1c | |
| Absolute Change From Baseline in Body Weight | Placebo | 0.77 | Standard Error 0.122 | kilograms (kg) | |
| Absolute Change From Baseline in Body Weight | Sotagliflozin 400 mg | -2.21 | Standard Error 0.122 | kilograms (kg) | |
| Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) | Placebo | -5.7 | Standard Error 0.90 | mmHg | |
| Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) | Sotagliflozin 400 mg | -9.2 | Standard Error 0.92 | mmHg | |
| Percent Change From Baseline in Mean Daily Bolus Insulin Dose | Placebo | 6.62 | Standard Error 2.272 | percent change in IU/day | |
| Percent Change From Baseline in Mean Daily Bolus Insulin Dose | Sotagliflozin 400 mg | -5.71 | Standard Error 2.289 | percent change in IU/day |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 705 | |
| Overall Study | STARTED | Sotagliflozin 400 mg | 700 | |
| Overall Study | Treated | Placebo | 703 | |
| Overall Study | Treated | Sotagliflozin 400 mg | 699 | |
| Overall Study | COMPLETED | Placebo | 624 | |
| Overall Study | COMPLETED | Sotagliflozin 400 mg | 605 | |
| Overall Study | NOT COMPLETED | Placebo | 81 | |
| Overall Study | NOT COMPLETED | Sotagliflozin 400 mg | 95 |
Source ClinicalTrials.gov
Adverse events104
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 | 17 | 703 | 22 |
| other | Diarrhoea | Gastrointestinal disorders | Sotagliflozin 400 mg | 35 | 699 | 41 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo | 55 | 703 | 62 |
| other | Viral upper respiratory tract infection | Infections and infestations | Sotagliflozin 400 mg | 41 | 699 | 46 |
| serious | Hypotension | Vascular disorders | Placebo | 0 | 703 | 0 |
| serious | Hypotension | Vascular disorders | Sotagliflozin 400 mg | 1 | 699 | 1 |
| serious | Peripheral arterial occlusive disease | Vascular disorders | Placebo | 1 | 703 | 1 |
| serious | Peripheral arterial occlusive disease | Vascular disorders | Sotagliflozin 400 mg | 0 | 699 | 0 |
| serious | Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 703 | 1 |
| serious | Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sotagliflozin 400 mg | 0 | 699 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 703 |
| Total, all-cause mortality | Sotagliflozin 400 mg | 1 | 699 |
| Total, other adverse events | Placebo | 70 | 703 |
| Total, other adverse events | Sotagliflozin 400 mg | 70 | 699 |
| Total, serious adverse events | Placebo | 23 | 703 |
| Total, serious adverse events | Sotagliflozin 400 mg | 48 | 699 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28899222 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sotagliflozin 400 mg vs Placebo: deaths from any cause | Trial comparisons |
| Sotagliflozin 400 mg vs Placebo: serious adverse events | Trial comparisons |
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/NCT02531035
GET https://conductscience.org/api/trials/v1/NCT02531035/events?page=2