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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01311076 | TAK-329 Glucose Clamp Study | PHASE1 | COMPLETED | 37 | — | — | Mar 1, 2011 | Jan 1, 2012 | Feb 13, 2012 | 1 | United States |
(AUCGIR 0-360) is measure of area under the curve of the glucose infusion rate from time 0 to 360 minutes (6 hours) post dose, measured in minutes during the glucose clamp procedure.
Maximum observed glucose infusion rate (GIRmax) is the peak glucose infusion rate of a drug after administration, obtained directly from the glucose infusion-time curve, measured in minutes during the glucose clamp procedure.
TGIRmax: Time to reach the maximum Glucose Infusion Rate (GIRmax), equal to time (hours) to GIRmax, measured in minutes during the glucose clamp procedure.
| Arm | Type | Description |
|---|---|---|
| TAK-329 50 mg | EXPERIMENTAL | - |
| TAK-329 200 mg | EXPERIMENTAL | - |
| Insulin 0.2 U/kg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-329 | DRUG | TAK-329 50 mg, tablets, orally, single dose, one day. |
| Insulin | DRUG | Insulin 0.2 U/kg, subcutaneous injection, single dose, one day. |
| Placebo | DRUG | TAK-329 placebo-matching tablets, orally, single dose, one day. |
Inclusion Criteria: 1. In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent ...