Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LX4211 · 11 trials · 4 indications
To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
| LX4211 Low Dose | EXPERIMENTAL | 400 mg of LX4211 administered once daily for 10 consecutive days |
| LX4211 High Dose | EXPERIMENTAL | 800 mg of LX4211 administered once daily for 10 consecutive days |
| LX4211 | EXPERIMENTAL | 400 mg of LX4211 |
| Canagliflozin | ACTIVE_COMPARATOR | 300 mg canagliflozin |
| [14C]-LX4211 | EXPERIMENTAL | 400 mg LX4211 administered orally |
| LX4211 Placebo | PLACEBO_COMPARATOR | - |
| Solid Oral Dose - 150 mg tablets | EXPERIMENTAL | - |
| Solid Oral Dose - 50 mg tablets | EXPERIMENTAL | - |
| Liquid Oral Dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 75 mg LX4211 | DRUG | Subjects will receive 75 mg LX4211 once daily |
| 200 mg LX4211 | DRUG | Subjects will receive 200 mg LX4211 once daily. |
| 400 mg LX4211 | DRUG | Subjects will receive 400 mg LX4211 once daily. |
| Placebo | DRUG | Subjects will receive placebo once daily. |
| LX4211 Low Dose | DRUG | A low dose of LX4211; daily oral intake for 28 days |
| LX4211 High Dose | DRUG | A high dose of LX4211; daily oral intake for 28 days |
| LX4211 | DRUG | Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9 |
| LX4211 400 mg | DRUG | - |
| LX4211 800 mg | DRUG | - |
| LX4211 Placebo | DRUG | - |
| canagliflozin 300 mg | DRUG | - |
| LX4211 2000 mg | DRUG | - |
| moxifloxacin 400 mg | DRUG | - |
| [14C]-LX4211 | DRUG | - |
| Januvia® | DRUG | 100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet |
| 1000 mg metformin | DRUG | 1000 mg metformin given as a solid oral dose form |
| 300 mg LX4211 (150 mg tablets) | DRUG | Single oral dose of two 150 mg tablets LX4211 |
| 300 mg LX4211 (50 mg tablets) | DRUG | Single oral dose of six 50 mg tablets LX4211 |
| 300 mg LX4211 (liquid) | DRUG | Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL) |
Inclusion Criteria: * Adult subjects between the ages of 18 to 75 years, inclusive * Confirmed diagnosis of Type 2 diabetes mellitus * Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL * Stable dose of metformin monotherapy greater than 1500 mg/day f...
LX4211 is an investigational small molecule being studied for use in Type 2 Diabetes Mellitus and in healthy subjects. It has been evaluated in Phase 1 clinical trials, including studies of its interaction with metformin, its co-administration with Januvia, and its effects in patients with renal impairment.
LX4211 is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LXRX. The company has sponsored multiple Phase 1 clinical trials of the drug in the United States.
LX4211 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All six clinical trials listed for LX4211 are Phase 1 studies, and all have been completed.
LX4211 has been studied in several completed Phase 1 trials, including NCT01292993 (interaction with metformin in Type 2 Diabetes), NCT01441232 (co-administration with Januvia), NCT01555008 (effects in Type 2 Diabetes with renal impairment), and NCT01916863 (comparison with canagliflozin on intestinal glucose absorption in healthy subjects).
LX4211 is also known by the name sotagliflozin. It is an investigational small molecule being developed by Lexicon Pharmaceuticals for Type 2 Diabetes Mellitus. The drug has been evaluated in Phase 1 trials, but it is not yet approved.