Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-329 · 1 trial · 1 indication
(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 ...
TAK-329 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential effects on glucose control in patients with this condition.
TAK-329 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical research to evaluate the safety and efficacy of TAK-329 in patients with Type 1 Diabetes Mellitus.
TAK-329 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for Type 1 Diabetes Mellitus.
TAK-329 has one completed clinical trial registered under NCT01311076, titled "TAK-329 Glucose Clamp Study." This Phase 1 trial enrolled 37 participants with Type 1 Diabetes Mellitus in the United States. The study was randomized, double-blind, and placebo-controlled, and it has been completed.
TAK-329 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 1 Diabetes Mellitus. The drug has not completed the clinical trials necessary to demonstrate safety and efficacy for regulatory approval, and it remains under investigation.