Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01376557 | Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin | PHASE2 | COMPLETED | 299 | — | — | Jun 1, 2011 | May 1, 2012 | Oct 31, 2014 | 56 | United States |
| NCT00962065 | Study of LX4211 in Subjects With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 36 | — | — | Aug 1, 2009 | - | Mar 3, 2011 | 1 | United States |
| NCT01555008 | Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment | PHASE1 | COMPLETED | 31 | — | — | Mar 1, 2012 | - | Sep 9, 2013 | 6 | United States |
| NCT01441232 | A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics | PHASE1 | COMPLETED | 18 | — | — | Oct 1, 2011 | - | Jan 31, 2012 | 1 | United States |
| NCT01292993 | A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects | PHASE1 | COMPLETED | 18 | — | — | Feb 1, 2011 | - | Mar 30, 2011 | 1 | United States |
| NCT01188863 | Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 15 | — | — | Sep 1, 2010 | - | Mar 30, 2011 | 1 | United States |
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 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 | Subjects will receive LX4211 once daily for 7 days |
| LX4211 Placebo | DRUG | Subjects will receive LX4211 placebo once daily for 7 days |
| 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...