ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01876849
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : February 24, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
Study Start Date : December 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A
Exenatide injection 5mcg or 10 mcg, twice daily
Drug: exenatide
subcutaneous injection, 5mcg or 10 mcg, twice daily
Other Name: Byetta



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876849


Locations
United States, Washington
Research Site
Renton, Washington, United States
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01876849     History of Changes
Other Study ID Numbers: H8O-MC-GWAN
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: January 2015

Keywords provided by AstraZeneca:
diabetes
exenatide
Byetta
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists