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TAK-329 Glucose Clamp Study

NCT01311076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-02-13

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

TAK-329

TAK-329 50 mg, tablets, orally, single dose, one day.

DRUG

TAK-329

TAK-329 200 mg, tablets, orally, single dose, one day.

DRUG

Insulin

Insulin 0.2 U/kg, subcutaneous injection, single dose, one day.

DRUG

Placebo

TAK-329 placebo-matching tablets, orally, single dose, one day.

Sponsors & Collaborators

Principal Investigators

  • Associate Medical Director, Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01311076 on ClinicalTrials.gov