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A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes

NCT00612794 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-02-24

No results posted yet for this study

Summary

Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.

Conditions

Interventions

DRUG

exenatide once weekly

subcutaneous injection, once weekly

DRUG

placebo

subcutaneous injection, once weekly

Sponsors & Collaborators

Principal Investigators

  • Chief Medical Officer, MD · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00612794 on ClinicalTrials.gov