search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
exenatide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring exenatide, diabetes, Amylin, exendin-4

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exenatide

Arm Description

Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination

Outcomes

Primary Outcome Measures

Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
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
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
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
Change in lipids from Visit 1 to each visit up to open-ended study termination

Secondary Outcome Measures

Full Information

First Posted
May 23, 2005
Last Updated
February 19, 2015
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00111540
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
exenatide, diabetes, Amylin, exendin-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Experimental
Arm Description
Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta, exendin-4, AC2993
Intervention Description
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Primary Outcome Measure Information:
Title
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
Description
Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Time Frame
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Title
Change in body weight from Visit 1 to each protocol visit
Description
Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
Time Frame
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Title
Change in fasting plasma glucose from Visit 1 to each protocol visit
Description
Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Time Frame
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Title
Change in lipids from Visit 1 to each protocol visit
Description
Change in lipids from Visit 1 to each visit up to open-ended study termination
Time Frame
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Bellflower
State/Province
California
Country
United States
Facility Name
Research Site
City
Burlingame
State/Province
California
Country
United States
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
Research Site
City
Concord
State/Province
California
Country
United States
Facility Name
Research Site
City
Encino
State/Province
California
Country
United States
Facility Name
Research Site
City
Fremont
State/Province
California
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Gatos
State/Province
California
Country
United States
Facility Name
Research Site
City
Moreno Valley
State/Province
California
Country
United States
Facility Name
Research Site
City
Redwood City
State/Province
California
Country
United States
Facility Name
Research Site
City
San Mateo
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Largo
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Blairsville
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Covington
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Slidell
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Gulfport
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Picayune
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cary
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Marion
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Maumee
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Clinton
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Midland
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16776751
Citation
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. doi: 10.1111/j.1463-1326.2006.00602.x.
Results Reference
result
PubMed Identifier
17379054
Citation
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. doi: 10.1016/j.clinthera.2007.01.015.
Results Reference
result
PubMed Identifier
18053320
Citation
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. doi: 10.1185/030079908x253870.
Results Reference
result
PubMed Identifier
22236356
Citation
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.
Results Reference
derived
PubMed Identifier
17705687
Citation
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. doi: 10.1089/dia.2006.0024.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs