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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.201 |
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The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | A low dose of LX4211; daily oral intake for 28 days |
|
| High Dose | Experimental | A high dose of LX4211; daily oral intake for 28 days |
|
| Placebo | Placebo Comparator | Matching placebo dosing with daily oral intake for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX4211 Low Dose | Drug | A low dose of LX4211; daily oral intake for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion | To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 29 in Fasting Plasma Glucose | Baseline to Day 29 | |
| Change From Baseline at Day 28 in Plasma HbA1c | Baseline to Day 28 | |
| Change From Baseline at Day 28 in Plasma Fructosamine Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel P. Freiman, MD, MPH | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22739142 | Derived | Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4. |
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There was a 14-day washout period and a 5-day diet stabilization period prior to randomization.
This was a single-center trial in the United States, with 1 investigator participating.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | A low dose of LX4211; daily oral intake for 28 days |
| FG001 | High Dose | A high dose of LX4211; daily oral intake for 28 days |
| FG002 | Placebo | Matching placebo dosing with daily oral intake for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | A low dose of LX4211; daily oral intake for 28 days |
| BG001 | High Dose | A high dose of LX4211; daily oral intake for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 at Day 28 in 24-hour Urinary Glucose Excretion | To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration. | Posted | Mean | 95% Confidence Interval | grams | Baseline to Day 28 |
|
Adverse events were followed during the treatment period.
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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 | Low Dose | A low dose of LX4211; daily oral intake for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel P. Freiman, MD, MPH | Lexicon Pharmaceuticals, Inc. | 281-863-3000 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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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| LX4211 High Dose |
| Drug |
A high dose of LX4211; daily oral intake for 28 days |
|
| Placebo | Drug | Matching placebo dosing with daily oral intake for 28 days |
|
| Baseline to Day 28 |
| Change From Baseline at Day 28 in Mean Arterial Pressure | Baseline to Day 28 |
| Change From Baseline at Day 28 in Triglycerides | Baseline to Day 28 |
| BG002 | Placebo | Matching placebo dosing with daily oral intake for 28 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change From Baseline at Day 29 in Fasting Plasma Glucose | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to Day 29 |
|
|
|
| Secondary | Change From Baseline at Day 28 in Plasma HbA1c | Posted | Mean | 95% Confidence Interval | Percent | Baseline to Day 28 |
|
|
|
| Secondary | Change From Baseline at Day 28 in Plasma Fructosamine Level | Posted | Mean | 95% Confidence Interval | µmol/L | Baseline to Day 28 |
|
|
|
| Secondary | Change From Baseline at Day 28 in Mean Arterial Pressure | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to Day 28 |
|
|
|
| Secondary | Change From Baseline at Day 28 in Triglycerides | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to Day 28 |
|
|
|
| 0 |
| 12 |
| 9 |
| 12 |
| EG001 | High Dose | A high dose of LX4211; daily oral intake for 28 days | 0 | 12 | 8 | 12 |
| EG002 | Placebo | Matching placebo dosing with daily oral intake for 28 days | 0 | 12 | 8 | 12 |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bacteriuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritis genital | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Trichomoniasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
The sponsor requires that written permission be given before the PI can release any data publicly.
| D004700 | Endocrine System Diseases |
|
| Supine |
|