TAK-329 Glucose Clamp Study

Type 1 diabetes mellitus (T1DM), also known as insulin-dependent diabetes mellitus or
juvenile-onset diabetes, occurs primarily due to β-cell destruction, usually leading to
absolute insulin deficiency. The condition is immune-mediated and is usually idiopathic.
Tight glycemic control using intensive insulin therapy was shown in the Diabetes Control and
Complications Trial (DCCT) to reduce rates of microvascular complications in T1DM; however,
achieving and maintaining such control in T1DM using standard insulin therapy requires a
high level of support and is associated with increased potential for hypoglycemia, increased
weight gain and, in some patients, aggravation of cardiovascular risk factors including
dyslipidemia.

TAK-329 is being developed by Takeda Global Research & Development Center, Inc. (TGRD) as
an adjunct treatment to improve glycemic control in patients with type 1 diabetes mellitus
who use insulin therapy.

This study will take place at 1 site in the United States. A total of 36 male and female
adult participants with T1DM will take part in the study.

The study will last about 77 days, including a 28 days screening period, 4 cross-over
treatment periods and a follow up period. Participants will be confined to the study clinic
for 2 days in each period. Participants will also be contacted by phone 30 days following
the last dose of study drug.