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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.203 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotagliflozin 400 mg - Pioneer Group | Experimental | Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. |
|
| Placebo - Expansion Group | Placebo Comparator | Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration. |
|
| Sotagliflozin 400 mg - Expansion Group | Experimental | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | 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. | Baseline, Day 3 to Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Strumph, M.D. | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Aurora | Colorado | 80045 | United States | ||
| Lexicon Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26049551 | Derived | Sands AT, Zambrowicz BP, Rosenstock J, Lapuerta P, Bode BW, Garg SK, Buse JB, Banks P, Heptulla R, Rendell M, Cefalu WT, Strumph P. Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes. Diabetes Care. 2015 Jul;38(7):1181-8. doi: 10.2337/dc14-2806. Epub 2015 Jun 6. |
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In this study, first 3 participants (Pioneer Group) received open-label sotagliflozin. Once dosing was completed in Pioneer Group, 33 different participants were randomized in 1:1 ratio to Expansion groups (sotagliflozin or placebo). Randomization was stratified according to baseline glycosylated hemoglobin (A1C [<=8 percent {%} vs. >8%]).
The study was conducted at 7 sites in United States between 08 February 2013 and 13 January 2014. A total of 36 participants were enrolled and treated in the study which consisted of 2 groups: Pioneer Group and Expansion Groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotagliflozin 400 mg - Pioneer Group | Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. |
| FG001 | Placebo - Expansion Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Participants received placebo-matching sotagliflozin tablets once daily for 29 days. |
|
| Sotagliflozin | Drug | Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants. |
|
|
| Baseline, Day 3 to Day 27 |
| 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 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. | Baseline, Day 3 to Day 27 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at 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. | Baseline, Day 29 |
| 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 | 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. | 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 |
| 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 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. | Baseline, Day 3 to Day 27 |
| Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups | 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. | From 15 minutes before start of mixed meal until 180 min post start of mixed meal, on Day 1 and Day 29 |
| Atlanta |
| Georgia |
| 30318 |
| United States |
| Lexicon Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Lexicon Investigational Site | Omaha | Nebraska | 68131 | United States |
| Lexicon Investigational Site | The Bronx | New York | 10467 | United States |
| Lexicon Investigational Site | Durham | North Carolina | 27713 | United States |
| Lexicon Investigational Site | Dallas | Texas | 75230 | United States |
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
| FG002 | Sotagliflozin 400 mg - Expansion Group | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. |
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis was performed using intent-to-treat (ITT) population which consisted of all participants who were randomized in the Expansion Group and participants who received at least 1 dose of study treatment in the Pioneer Group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sotagliflozin 400 mg - Pioneer Group | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. |
| BG001 | Placebo - Expansion Group | Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration. |
| BG002 | Sotagliflozin 400 mg - Expansion Group | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Insulin Therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) | 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. | Analysis was performed using ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, Day 3 to Day 27 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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. | Analysis was performed using ITT population. Here, number analyzed=participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, Day 3 to Day 27 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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. | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, Day 3 to Day 27 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at 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. | Analysis was performed on ITT population. | Posted | Least Squares Mean | 95% Confidence Interval | milligram/deciliter (mg/dL) | Baseline, Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg*h/dL | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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. | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent time per day | Baseline, Day 3 to Day 27 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | gram per 3 hour | From 15 minutes before start of mixed meal until 180 min post start of mixed meal, on Day 1 and Day 29 |
|
All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotagliflozin 400 mg - Pioneer Group | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG001 | Placebo - Expansion Group | Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration. | 0 | 17 | 0 | 17 | 12 | 17 |
| EG002 | Sotagliflozin 400 mg - Expansion Group | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. | 0 | 16 | 2 | 16 | 14 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA(15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| ABNORMAL FAECES | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDRA(15.0) | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA(15.0) | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA(15.0) | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA(15.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA(15.0) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA(15.0) | Systematic Assessment |
| |
| FAECES HARD | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA(15.0) | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA(15.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA(15.0) | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA(15.0) | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA(15.0) | Systematic Assessment |
| |
| LICE INFESTATION | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA(15.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA(15.0) | Systematic Assessment |
| |
| NAIL INFECTION | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| NAIL OPERATION | Surgical and medical procedures | MedDRA(15.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA(15.0) | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA(15.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA(15.0) | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA(15.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA(15.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA(15.0) | Systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA(15.0) | Systematic Assessment |
| |
| SINUS HEADACHE | Nervous system disorders | MedDRA(15.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| SKIN IRRITATION | Skin and subcutaneous tissue disorders | MedDRA(15.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA(15.0) | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA(15.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA(15.0) | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | 800-633-1610 | 1# | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Continuous Subcutaneous Insulin Infusion (CSII) |
|
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. |
|
|
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. |
|
|