TAK-329 Glucose Clamp Study

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the safety, tolerability, pharmacokinetic and pharmacodynamic properties of single doses of TAK-329 with a single dose of a subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes mellitus.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01311076
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 1
Start date	March 2011
Completion date	January 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.