- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876849
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
February 23, 2015 updated by: AstraZeneca
The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study).
Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.
Study Overview
Study Type
Interventional
Enrollment (Actual)
275
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Renton, Washington, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study.
Exclusion Criteria:
- Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD.
- Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Exenatide injection 5mcg or 10 mcg, twice daily
|
subcutaneous injection, 5mcg or 10 mcg, twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.
Time Frame: 128 weeks (average treatment period)
|
Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing.
|
128 weeks (average treatment period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
July 14, 2009
First Submitted That Met QC Criteria
June 11, 2013
First Posted (Estimate)
June 13, 2013
Study Record Updates
Last Update Posted (Estimate)
February 24, 2015
Last Update Submitted That Met QC Criteria
February 23, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H8O-MC-GWAN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on exenatide
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusUnited States
-
AstraZenecaCompletedType 2 Diabetes MellitusCanada, United States
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusKorea, Republic of, China, Japan, Taiwan, India
-
Beijing Chao Yang HospitalCompleted
-
AstraZenecaCompletedDiabetes Mellitus, Type 2United States
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusKorea, Republic of, Mexico, Germany, Greece, Argentina, India, Australia
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusUnited States
-
AstraZenecaEli Lilly and CompanyCompletedType 2 DiabetesUnited States
-
AstraZenecaCelerionCompleted
-
University at BuffaloAmylin Pharmaceuticals, LLC.Completed