Safety and Efficacy of Exenatide as Monotherapy
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exenatide
exenatide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, exenatide, Amylin, Lilly, monotherapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with type 2 diabetes
- Treating diabetes with diet and exercise
- HbA1c between 6.5% and 10.0%, inclusive
- Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive
Exclusion Criteria:
- Have previously completed or withdrawn from this study
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Have been treated with any antidiabetic agent
- Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
- Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
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- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Exenatide 5 mcg/exenatide 5 mcg
Exenatide 5 mcg/exenatide 10 mcg
Placebo
Arm Description
Exenatide 5 mcg; then exenatide 5 mcg
Exenatide 5 mcg, then exenatide 10 mcg
Placebo in volumes equivalent to exenatide
Outcomes
Primary Outcome Measures
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
Change in HbA1c from Baseline to Week 24
Secondary Outcome Measures
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Change in fasting serum glucose (FSG) from Baseline to Week 24
Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between
Change in body weight from Baseline to Week 24
Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between
Change in glucose measurements from Baseline to Week 24
Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between
Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between
Changes in fasting and 30, 60, 120 and 180-minute glucose measurements
Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin
Full Information
NCT ID
NCT00381342
First Posted
September 25, 2006
Last Updated
February 20, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00381342
Brief Title
Safety and Efficacy of Exenatide as Monotherapy
Official Title
Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, exenatide, Amylin, Lilly, monotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide 5 mcg/exenatide 5 mcg
Arm Type
Experimental
Arm Description
Exenatide 5 mcg; then exenatide 5 mcg
Arm Title
Exenatide 5 mcg/exenatide 10 mcg
Arm Type
Experimental
Arm Description
Exenatide 5 mcg, then exenatide 10 mcg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in volumes equivalent to exenatide
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
Primary Outcome Measure Information:
Title
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
Description
Change in HbA1c from Baseline to Week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Description
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Time Frame
Baseline, Weeks 4, 8, 12, 16, 24
Title
Change in fasting serum glucose (FSG) from Baseline to Week 24
Description
Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between
Time Frame
Baseline, Weeks 4, 8, 12, 16, and 24
Title
Change in body weight from Baseline to Week 24
Description
Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between
Time Frame
Baseline, Weeks 4, 8, 12, 16, and 24
Title
Change in glucose measurements from Baseline to Week 24
Description
Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between
Time Frame
Baseline, Weeks 4, 8, 12, 16, 24
Title
Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
Description
Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between
Time Frame
Baseline, Weeks 4, 8, 12, 16, and 24
Title
Changes in fasting and 30, 60, 120 and 180-minute glucose measurements
Description
Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin
Time Frame
Immediately before glucose load, then 30, 60, 120, and 180 minutes post
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 2 diabetes
Treating diabetes with diet and exercise
HbA1c between 6.5% and 10.0%, inclusive
Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive
Exclusion Criteria:
Have previously completed or withdrawn from this study
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Have been treated with any antidiabetic agent
Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Aligarh
Country
India
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Chennai
Country
India
Facility Name
Research Site
City
Indore
Country
India
Facility Name
Research Site
City
Karnal
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Vellore
Country
India
Facility Name
Research Site
City
Manati
Country
Puerto Rico
Facility Name
Research Site
City
San Juan
Country
Puerto Rico
Facility Name
Research Site
City
Alba Iulia
Country
Romania
Facility Name
Research Site
City
Baia Mare
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Galati
Country
Romania
Facility Name
Research Site
City
Oradea
Country
Romania
Facility Name
Research Site
City
Targu Mures
Country
Romania
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
18803987
Citation
Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006. Erratum In: Clin Ther. 2008 Oct;30(10):1937.
Results Reference
result
PubMed Identifier
22913891
Citation
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Results Reference
derived
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
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Safety and Efficacy of Exenatide as Monotherapy
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