Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.206 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks. |
|
| Sotagliflozin 75 mg | Experimental | Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks. |
|
| Sotagliflozin 200 mg | Experimental | Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks. |
|
| Sotagliflozin 400 mg | Experimental | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo, 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. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion [CSII] or multiple daily injection [MDI]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal | 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. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suman Wason, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Concord | California | 94520 | United States | ||
| Lexicon Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31264767 | Derived | Baker C, Wason S, Banks P, Sawhney S, Chang A, Danne T, Gesty-Palmer D, Kushner JA, McGuire DK, Mikell F, O'Neill M, Peters AL, Strumph P. Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial. Diabetes Obes Metab. 2019 Nov;21(11):2440-2449. doi: 10.1111/dom.13825. Epub 2019 Aug 1. |
Not provided
Not provided
207 participants were screened and 141 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy alone, were randomized equally into four treatment groups: sotagliflozin 75 milligrams (mg), sotagliflozin 200 mg, sotagliflozin 400 mg or placebo.
The study was conducted at 17 centers in the United States from 10 July 2015 to 26 August 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks. |
| FG001 | Sotagliflozin 75 mg | Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sotagliflozin | Drug | Sotagliflozin,once daily, before the first meal of the day |
|
| Baseline, Week 12 |
| Absolute Change From Baseline in Body Weight to Week 12 | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate. | Baseline to Week 12 |
| Percent Change From Baseline in Body Weight to Week 12 | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate. | Baseline to Week 12 |
| Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion | Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate. | Baseline, Week 12 |
| Change From Baseline to Week 12 in Fasting Plasma Glucose | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate. | Baseline to Week 12 |
| Ventura |
| California |
| 93003 |
| United States |
| Lexicon Investigational Site | Denver | Colorado | 80209 | United States |
| Lexicon Investigational Site | Jacksonville | Florida | 32225 | United States |
| Lexicon Investigational Site | Miami | Florida | 33175 | United States |
| Lexicon Investigational Site | Springfield | Illinois | 62711 | United States |
| Lexicon Investigational Site | Metairie | Louisiana | 70006 | United States |
| Lexicon Investigational Site | Auburn | Maine | 04210 | United States |
| Lexicon Investigational Site | Rockville | Maryland | 20852 | United States |
| Lexicon Investigational Site | Great Falls | Montana | 59405 | United States |
| Lexicon Investigational Site | Omaha | Nebraska | 68114 | United States |
| Lexicon Investigational Site | High Point | North Carolina | 27265 | United States |
| Lexicon Investigational Site | Columbus | Ohio | 43213 | United States |
| Lexicon Investigational Site | San Antonio | Texas | 78229 | United States |
| Lexicon Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Lexicon Investigational Site | Chesapeake | Virginia | 23321 | United States |
| Lexicon Investigational Site | Manassas | Virginia | 20110 | United States |
| FG002 | Sotagliflozin 200 mg | Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks. |
| FG003 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Intent-to-treat (mITT) population consisted of all randomly assigned participants who had taken at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks. |
| BG001 | Sotagliflozin 75 mg | Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks. |
| BG002 | Sotagliflozin 200 mg | Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks. |
| BG003 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
| BG004 | 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 |
| ||||||||||||||||
| Body Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Daily Total Insulin Dose | Mean | Standard Deviation | International units per kilogram (IU/kg) |
| |||||||||||||||
| Hemoglobin A1C (A1c) | Mean | Standard Deviation | percentage of A1C |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kilograms per meter square |
| |||||||||||||||
| Duration of Diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Insulin delivery method in Participants | 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 | 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. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion [CSII] or multiple daily injection [MDI]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate. | 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 | percentage of A1C | Baseline to Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal | 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. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate. | 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 | milligrams per deciliter (mg/dL) | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Body Weight to Week 12 | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate. | 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 | kilograms | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Body Weight to Week 12 | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate. | 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 | percent change | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion | Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate. | 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 | grams per day | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Fasting Plasma Glucose | Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate. | 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 | mg/dL | Baseline to Week 12 |
|
Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
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 | Placebo | Two placebo-matching sotagliflozin tablets, once daily, orally, for 12 weeks. | 0 | 36 | 1 | 36 | 10 | 36 |
| EG001 | Sotagliflozin 75 mg | Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks. | 0 | 35 | 1 | 35 | 5 | 35 |
| EG002 | Sotagliflozin 200 mg | Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks. | 0 | 35 | 1 | 35 | 6 | 35 |
| EG003 | Sotagliflozin 400 mg | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. | 0 | 35 | 1 | 35 | 4 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA(17.1) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA(17.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA(17.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA(17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA(17.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA(17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA(17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA(17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA(17.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA(17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA(17.1) | 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 |
|
| multiple daily injection (MDI) |
|
| Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate. | MMRM | <0.001 | Threshold for significance < 0.05 | Least squares mean difference | -0.48 | Standard Error of the Mean | 0.135 | 2-Sided | 95 | -0.75 | -0.22 | Superiority |
| Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate. | MMRM | 0.006 | Threshold for significance < 0.05 | Least squares mean difference | -0.38 | Standard Error of the Mean | 0.136 | 2-Sided | 95 | -0.65 | -0.11 | Superiority |
| OG003 |
| Sotagliflozin 400 mg |
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
|
|
| Sotagliflozin 400 mg |
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
|
|
| Sotagliflozin 400 mg |
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
|
|
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
|
|
| Sotagliflozin 400 mg |
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks. |
|
|