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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01474083 | A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes | PHASE1 | COMPLETED | 248 | — | — | Nov 1, 2011 | Sep 1, 2012 | Sep 13, 2013 | 11 | United States |
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
| Arm | Type | Description |
|---|---|---|
| GK1-399, low dose | EXPERIMENTAL | - |
| GK1-399, high dose, once per day | EXPERIMENTAL | - |
| GK1-399, high dose, twice per day | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GK1-399 (formerly TTP399) | DRUG | Treatment A: GK1-399 200 mg. Oral administration, twice per day. |
| Placebo | DRUG | Dose-matched placebo. Oral administration. |
Inclusion Criteria: * Be male or female, aged 18 through 75 years at screening. * Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) * On a stable dose of background medication for the treatment of diabetes * Body Mass Index (BMI) between 20-40 kg/m2 (inclusive) Exclusion Criteria: * Subjects wi...