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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:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00111540
First received: May 23, 2005
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

May 23, 2005
February 5, 2013
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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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
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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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00111540
2993-119
No
Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
February 2013

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