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

Tracking Information
First Submitted Date ICMJE	May 23, 2005
First Posted Date ICMJE	May 24, 2005
Last Update Posted Date	February 23, 2015
Study Start Date ICMJE	November 2002
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 5, 2013)	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
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00111540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus, Type 2
Intervention ICMJE	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
Study Arms	Experimental: Exenatide; Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination; Intervention: Drug: exenatide
Publications *	Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab. 2006 Jul;8(4):436-47.; Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007 Jan;29(1):139-53.; Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008 Jan;24(1):275-86.; Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.; Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 5, 2013)	456
Original Enrollment ICMJE; (submitted: June 23, 2005)	400
Actual Study Completion Date	September 2006
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00111540
Other Study ID Numbers ICMJE	2993-119
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ICMJE	AstraZeneca
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
PRS Account	AstraZeneca
Verification Date	January 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP