Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002041-30 | |||
| U1111-1195-6371 | Other Identifier | UTN |
Not provided
Not provided
Study terminated prematurely for financial reasons and Covid-19 pandemic.
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.
Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks, 2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week double-blind extension period, and a 2- week post treatment follow up period.
Dual-energy X-ray absorptiometry (DXA) scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks. |
|
| Sotagliflozin 200 mg | Experimental | Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
|
| Sotagliflozin 400 mg | Experimental | Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Pharmaceutical form: Tablet; Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 | An analysis of covariance (ANCOVA) model is used for analysis. | Baseline to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | An ANCOVA model is used for analysis. | Baseline to Week 26 |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 |
Not provided
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 8409009 | Escondido | California | 92025 | United States | ||
| Investigational Site Number 8409010 |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants with a diagnosis of Type 2 Diabetes Mellitus (DM), were enrolled in 1 of 3 treatment groups: Placebo, Sotagliflozin 200 milligrams (mg) or Sotagliflozin 400 mg.
Participants took part in the study at 53 investigative sites in the United States, Australia, Canada, Korea, Republic of Mexico, New Zealand, Russian Federation, and Taiwan from 19 February 2018 to 30 May 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2017 | Apr 13, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Pharmaceutical form: Tablet; Route of administration: Oral |
|
An ANCOVA model is used for analysis.
| Baseline to Week 26 |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26 | An ANCOVA model is used for analysis. | Baseline to Week 26 |
| Change From Baseline in Body Weight at Week 26 | An ANCOVA model is used for analysis. | Baseline to Week 26 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | An ANCOVA model is used for analysis. | Baseline to Week 26 |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | An ANCOVA model is used for analysis. | Baseline to Week 12 |
| Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26 | Week 26 |
| Percentage of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. | up to 106 weeks |
| Greenbrae |
| California |
| 94904 |
| United States |
| Investigational Site Number 8409005 | Walnut Creek | California | 94598 | United States |
| Investigational Site Number 8409012 | Columbus | Georgia | 31904 | United States |
| Investigational Site Number 8409011 | Evansville | Indiana | 47714-8011 | United States |
| Investigational Site Number 8409014 | Wichita | Kansas | 67205-1138 | United States |
| Investigational Site Number 8409015 | Albuquerque | New Mexico | 87106 | United States |
| Investigational Site Number 8409002 | Chapel Hill | North Carolina | 27517 | United States |
| Investigational Site Number 8409001 | Wilmington | North Carolina | 28401-6638 | United States |
| Investigational Site Number 8409008 | Dayton | Ohio | 45419-4336 | United States |
| Investigational Site Number 8409004 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 8409013 | Austin | Texas | 78749 | United States |
| Investigational Site Number 8409003 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 8409007 | Katy | Texas | 77450 | United States |
| Investigational Site Number 0369003 | Fremantle | 6160 | Australia |
| Investigational Site Number 0369002 | Merewether | 2291 | Australia |
| Investigational Site Number 0369004 | Parkville | 3050 | Australia |
| Investigational Site Number 1249003 | Brampton | L6S 0C6 | Canada |
| Investigational Site Number 1249008 | Etobicoke | M9R 4E1 | Canada |
| Investigational Site Number 1249005 | Pointe-Claire | H9R 4S3 | Canada |
| Investigational Site Number 1249006 | Thornhill | L4J 1W3 | Canada |
| Investigational Site Number 1249004 | Thornhill | L4J 8L7 | Canada |
| Investigational Site Number 1249007 | Vancouver | V5Y 3W2 | Canada |
| Investigational Site Number 1249002 | Victoriaville | G6P 6P6 | Canada |
| Investigational Site Number 4849001 | Aguascalientes | 20129 | Mexico |
| Investigational Site Number 4849006 | Aguascalientes, Aguascalientes | 20230 | Mexico |
| Investigational Site Number 4849003 | Cuernavaca | 62250 | Mexico |
| Investigational Site Number 4849002 | Guadalajara Jalisco | 44130 | Mexico |
| Investigational Site Number 4849004 | Monterrey | 64460 | Mexico |
| Investigational Site Number 4849005 | Xalapa | 91020 | Mexico |
| Investigational Site Number 5549004 | Auckland | 1309 | New Zealand |
| Investigational Site Number 5549003 | Christchurch | 8011 | New Zealand |
| Investigational Site Number 5549001 | Rotorua | 3010 | New Zealand |
| Investigational Site Number 5549002 | Wellington | 6021 | New Zealand |
| Investigational Site Number 6439007 | Kemerovo | 650002 | Russia |
| Investigational Site Number 6439005 | Novosibirsk | 630091 | Russia |
| Investigational Site Number 6439001 | Saint Petersburg | 194358 | Russia |
| Investigational Site Number 6439002 | Saint Petersburg | 195213 | Russia |
| Investigational Site Number 6439003 | Saint Petersburg | 196601 | Russia |
| Investigational Site Number 6439006 | Yaroslavl | 150003 | Russia |
| Investigational Site Number 4109006 | Daejeon | 35233 | South Korea |
| Investigational Site Number 4109005 | Guri-Si, Gyeonggi-Do | 11923 | South Korea |
| Investigational Site Number 4109003 | Gyeonggi-do | 13620 | South Korea |
| Investigational Site Number 4109004 | Seoul | 03722 | South Korea |
| Investigational Site Number 4109001 | Seoul | 1830 | South Korea |
| Investigational Site Number 1589005 | Changhua | 500 | Taiwan |
| Investigational Site Number 1589008 | New Taipei City | 220 | Taiwan |
| Investigational Site Number 1589006 | Taichung | 402 | Taiwan |
| Investigational Site Number 1589007 | Taichung | 43303 | Taiwan |
| Investigational Site Number 1589001 | Tainan | 710 | Taiwan |
| Investigational Site Number 1589002 | Tainan | Taiwan |
| Investigational Site Number 1589004 | Taipei | 100 | Taiwan |
| Investigational Site Number 1589003 | Taipei | 11217 | Taiwan |
| FG001 |
| Sotagliflozin 200 mg |
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
| FG002 | Sotagliflozin 400 mg | Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomized population included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks. |
| BG001 | Sotagliflozin 200 mg | Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
| BG002 | Sotagliflozin 400 mg | Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of HbA1c |
| |||||||||||||||
| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | millimeter of mercury (mmHg) |
| |||||||||||||||
| Bone Mineral Density (BMD) T-score: Lumbar Spine | BMD T-score Reference Ranges: Score (-1.0 and above): bone density is considered normal; Score (Between -1.0 and -2.5): sign of osteopenia, a condition that may lead to osteoporosis; Score (-2.5 and below): indicates likely osteoporosis. | Mean | Standard Deviation | t-score |
| ||||||||||||||
| BMD T-score: Total Hip | BMD T-score Reference Ranges: Score (-1.0 and above): bone density is considered normal; Score (Between -1.0 and -2.5): sign of osteopenia, a condition that may lead to osteoporosis; Score (-2.5 and below): indicates likely osteoporosis. | Mean | Standard Deviation | t-score |
| ||||||||||||||
| BMD T-score: Femoral Neck | BMD T-score Reference Ranges: Score (-1.0 and above): bone density is considered normal; Score (Between -1.0 and -2.5): sign of osteopenia, a condition that may lead to osteoporosis; Score (-2.5 and below): indicates likely osteoporosis. | Mean | Standard Deviation | t-score |
|
| 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 (HbA1c) at Week 26 | An analysis of covariance (ANCOVA) model is used for analysis. | Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline to Week 26 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26 | An ANCOVA model is used for analysis. | Safety population included all randomized participants who had received at least one dose of investigational medicinal product (IMP). Missing data are imputed using a pattern-based imputation method. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26 | An ANCOVA model is used for analysis. | Safety population included all randomized participants who had received at least one dose of IMP. Missing data are imputed using a pattern-based imputation method. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26 | An ANCOVA model is used for analysis. | Safety population included all randomized participants who had received at least one dose of IMP. Missing data are imputed using a pattern-based imputation method. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 26 | An ANCOVA model is used for analysis. | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline to Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | An ANCOVA model is used for analysis. | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework. | Posted | Least Squares Mean | Standard Error | milligram per deciliter (mg/dL) | Baseline to Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | An ANCOVA model is used for analysis. | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework. | Posted | Least Squares Mean | Standard Error | millimeter of mercury (mmHg) | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. | Posted | Number | percentage of participants | Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. | Safety population included all randomized participants who had received at least one dose of IMP. | Posted | Number | percentage of participants | up to 106 weeks |
|
First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
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 | Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks. | 1 | 125 | 20 | 125 | 66 | 125 |
| EG001 | Sotagliflozin 200 mg | Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. | 0 | 125 | 10 | 125 | 67 | 125 |
| EG002 | Sotagliflozin 400 mg | Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. | 0 | 125 | 9 | 125 | 68 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Maisonneuve fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of head and neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Spinal claudication | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | Lexicon Pharmaceuticals, Inc. | (510) 338-6064 | medical-information@lexpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2020 | Apr 13, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine 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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| South Korea |
|
| Mexico |
|
| New Zealand |
|
| Russia |
|
| Taiwan |
|
| United States |
|
The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, >8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate. |
| ANCOVA |
| <0.0001 |
| Difference in LS Means |
| -0.43 |
| Standard Error of the Mean |
| 0.102 |
| 2-Sided |
| 95 |
| -0.634 |
| -0.235 |
| Superiority |
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|
|
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|
|
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|
|
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|
|
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
|
|
|
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
|
|
|
|
|
|
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks. |
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|