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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01885260 | Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes | PHASE2 | COMPLETED | 77 | — | — | Jul 1, 2013 | Nov 1, 2014 | Jul 4, 2016 | 24 | United States, South Africa |
Change from Baseline to Week 14
| Arm | Type | Description |
|---|---|---|
| ISIS-GCGRRx Dose Level 1 | EXPERIMENTAL | ISIS-GCGRRx Dose Level 1 |
| ISIS-GCGRRx Dose Level 2 | EXPERIMENTAL | ISIS-GCGRRx Dose Level 2 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| ISIS-GCGRRx - Dose Level 1 | DRUG | 3 doses on alternate days during the first week and then once weekly for 12 weeks |
| ISIS-GCGRRx - Dose Level 2 | DRUG | 3 doses on alternate days during the first week and then once weekly for 12 weeks |
| Placebo | DRUG | 3 doses on alternate days during the first week and then once weekly for 12 weeks |
Inclusion Criteria: * Male or female, age 18 to 75 * BMI greater than or equal to 25 * HbA1c greater than or equal to 7.5% and less than or equal to 10.5% * Type 2 Diabetes Mellitus and on stable dose of oral metformin * Agree to conduct home-based (fasted) blood glucose testing as directed Exclus...