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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01648153 | Investigate the Efficacy and Safety of GSK1070806 in Obese Subjects With T2DM | PHASE2 | COMPLETED | 37 | — | — | Aug 1, 2012 | Jan 1, 2014 | Nov 21, 2016 | 13 | Spain, United Kingdom |
To evaluate the efficacy of two repeat intravenous dose administrations of GSK1070806 in subjects with T2DM
| Arm | Type | Description |
|---|---|---|
| GSK1070806 0.25mg/kg | ACTIVE_COMPARATOR | TwoIV administrations of 0.25mg/kg GSK1070806 4weeks apart |
| GSK1070806 5mg/kg | ACTIVE_COMPARATOR | Two IV administrations of 5mg/kg of GSK1070806 4 weeks apart |
| Placebo (Saline) | PLACEBO_COMPARATOR | Two IV administrations of saline 4 weeks apart |
| Name | Type | Description |
|---|---|---|
| GSK1070806 | BIOLOGICAL | To investigate the efficacy and biomarker changes of GSK1070806 after 0.25mg/kg IV administration |
| Placebo (saline) | OTHER | To compare the efficacy and biomarker changes between placebo and active groups |
Inclusion Criteria: 1. A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. 2. Male or female between 18 and 70 years of age inclusive, at th...