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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01755416 | Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting | PHASE2 | COMPLETED | 18 | — | — | Jan 1, 2013 | Jan 1, 2015 | Aug 21, 2018 | 1 | United States |
Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)
| Arm | Type | Description |
|---|---|---|
| Closed loop with sensor and Insulin | PLACEBO_COMPARATOR | subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone. |
| Closed loop with sensor, Insulin and Liraglutide | ACTIVE_COMPARATOR | Subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner, on Day 1. |
| Name | Type | Description |
|---|---|---|
| Closed loop with sensor and Insulin | DRUG | Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone. |
| Closed loop with sensor, Insulin and Liraglutide | DRUG | In this study visit the subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner on Day 1. |
Inclusion Criteria: * Age greater than 18 years and less than 40 years * Have had diabetes for at least 1 year, and in good control (HbA1C \< 8.5 %) * Be on continuous subcutaneous insulin infusion using an insulin pump * Menstruating women must have negative pregnancy test. * Hemoglobin (Hb) \> 12...