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A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

NCT00917267 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 691

Last updated 2015-04-09

Study results available
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Summary

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

Conditions

Interventions

DRUG

exenatide once weekly

2.0mg subcutaneous injection, once a week

DRUG

exenatide twice daily

5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)

Sponsors & Collaborators

Principal Investigators

  • Chief Medical Officer Officer, MD · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-09-30
Completion
2011-04-30

Countries

  • China
  • India
  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT00917267 on ClinicalTrials.gov