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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.204 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Sanofi | INDUSTRY |
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This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks. |
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| Sotagliflozin 400 mg | Experimental | Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Sotagliflozin 400 mg, once daily before the first meal of the day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (<=10%, >10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12 | The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sangeeta Sawhney, M.D. | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Tustin | California | 92780 | United States | ||
| Lexicon Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32640846 | Derived | Bode BW, Cengiz E, Wadwa RP, Banks P, Danne T, Kushner JA, McGuire DK, Peters AL, Strumph P, Sawhney S. Effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes: The JDRF Sotagliflozin Study. Diabetes Technol Ther. 2021 Jan;23(1):59-69. doi: 10.1089/dia.2020.0079. |
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147 participants were screened and 87 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy alone, were randomized equally into two treatment groups: sotagliflozin 400 milligrams (mg) or placebo.
The study was conducted at 15 sites in United States between 20 April 2015 and 23 September 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks. |
| FG001 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo, once daily before the first meal of the day |
|
| Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12 | A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model. | Baseline, Week 12 |
| Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12 | Glycemic instability (mg/dL*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit [Baseline and Week 12]) over 24 hours, where outside target range was defined as CGM glucose AUC >150 mg/dL (hyperglycemia) and CGM glucose AUC <70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model. | Baseline, Week 12 |
| Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12 | Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was <=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model. | Baseline, Week 12 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Lexicon Investigational Site | New Haven | Connecticut | 06519 | United States |
| Lexicon Investigational Site | Tampa | Florida | 33612 | United States |
| Lexicon Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Lexicon Investigational Site | Atlanta | Georgia | 30318 | United States |
| Lexicon Investigational Site | Roswell | Georgia | 30076 | United States |
| Lexicon Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Lexicon Investigational Site | New Orleans | Louisiana | 70121 | United States |
| Lexicon Investigational Site | Auburn | Maine | 04210 | United States |
| Lexicon Investigational Site | Boston | Massachusetts | 02215 | United States |
| Lexicon Investigational Site | Buffalo | New York | 14222 | United States |
| Lexicon Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Lexicon Investigational Site | Austin | Texas | 78749 | United States |
| Lexicon Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on modified intent-to treat (mITT) population which included all randomly assigned participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks. |
| BG001 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
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| Duration of diabetes | Mean | Standard Deviation | years |
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| Insulin Delivery Method | Count of Participants | Participants |
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| Hemoglobin A1C Level in Participants | Count of Participants | Participants |
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| Baseline daily total insulin | Mean | Standard Deviation | International units per kilogram (IU/kg) |
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| 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 | Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (<=10%, >10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of A1C | Baseline, Week 12 |
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| Secondary | Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12 | The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model. | Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | International Units per day (IU/day) | Baseline, Week 12 |
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| Secondary | Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12 | A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 12 |
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| Secondary | Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12 | Glycemic instability (mg/dL*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit [Baseline and Week 12]) over 24 hours, where outside target range was defined as CGM glucose AUC >150 mg/dL (hyperglycemia) and CGM glucose AUC <70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | mg/dL*minutes/1000 | Baseline, Week 12 |
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| Secondary | Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12 | Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was <=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model. | Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | events/day | Baseline, Week 12 |
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All Adverse Events (AEs) were collected from Baseline (Day 1) until the end of study (up to Week 12).
Analysis was performed on Safety Population defined as all randomly assigned participants who have taken at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks. | 0 | 42 | 3 | 42 | 16 | 42 |
| EG001 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks. | 0 | 43 | 2 | 43 | 21 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA(17.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA(17.1) | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA(17.1) | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA(17.1) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA(17.1) | Systematic Assessment |
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| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA(17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(17.1) | Systematic Assessment |
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| Blood ketone body increased | Investigations | MedDRA(17.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(17.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA(17.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA(17.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA(17.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA(17.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA(17.1) | Systematic Assessment |
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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 | 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 |
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| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Multiple Daily Injections (MDI) |
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| >10 % |
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| Participants |
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| Counts |
|---|
| Participants |
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