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Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111540
First Posted: May 24, 2005
Last Update Posted: February 23, 2015
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.
Information provided by (Responsible Party):
AstraZeneca
May 23, 2005
May 24, 2005
February 23, 2015
November 2002
September 2006   (Final data collection date for primary outcome measure)
  • Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
    Change in HbA1c from Visit 1 to each visit up to open-ended study termination
  • Change in body weight from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
    Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
  • Change in fasting plasma glucose from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
    Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
  • Change in lipids from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
    Change in lipids from Visit 1 to each visit up to open-ended study termination
Not Provided
Complete list of historical versions of study NCT00111540 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: exenatide
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Other Names:
  • Byetta
  • exendin-4
  • AC2993
Experimental: Exenatide
Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
Intervention: Drug: exenatide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
456
September 2006
September 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject has an HbA1c value <=11.0%
  • The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

Exclusion Criteria:

  • Is currently treated with certain medications, including exogenous insulin
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00111540
2993-119
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
January 2015

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