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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01876849
First received: July 14, 2009
Last updated: October 9, 2013
Last verified: October 2013

July 14, 2009
October 9, 2013
December 2003
July 2008   (final data collection date for primary outcome measure)
Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events. [ Time Frame: 128 weeks (average treatment period) ] [ Designated as safety issue: No ]
Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing.
Same as current
Complete list of historical versions of study NCT01876849 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: exenatide
subcutaneous injection, 5mcg or 10 mcg, twice daily
Other Name: Byetta
Experimental: Group A
Exenatide injection 5mcg or 10 mcg, twice daily
Intervention: Drug: exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01876849
H8O-MC-GWAN
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company
Bristol-Myers Squibb
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP