Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes
1 other identifier
interventional
239
1 country
29
Brief Summary
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started Dec 2014
Shorter than P25 for phase_4 type-2-diabetes
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
January 27, 2017
CompletedJanuary 27, 2017
December 1, 2016
8 months
November 7, 2014
March 23, 2016
December 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 24-hour Mean Weighted Glucose
Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).
Day 27/28
Secondary Outcomes (5)
Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient
Day 64/65
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Day 22/Day70
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Day 22 and Day 64
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Week 4 and Week 10
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Day 22 and Day 70
Study Arms (2)
Bydureon
EXPERIMENTALOnce weekly injected exenatide
Placebo
PLACEBO COMPARATORPlacebo comparator
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin \> or = to 1500mg/day as monotherapy for at least 8 weeks
- Hemoglobin A1c (HbA1c) 7% to 10% at screening
- Body mass index (BMI) \< or = to 45 kg/m2
You may not qualify if:
- History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
- History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
- History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
- History of prescription or over the counter weight loss medication during 3 months prior to screening
- Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
Research Site
Anaheim, California, United States
Research Site
Chino, California, United States
Research Site
Los Angeles, California, United States
Research Site
North Hollywood, California, United States
Research Site
Santa Ana, California, United States
Research Site
Spring Valley, California, United States
Research Site
Tustin, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Hollywood, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Marietta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Edina, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Franklin, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Katy, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Olympia, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sergey Zhuplatov MD, PhD
- Organization
- AstraZeneca, PLL
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 11, 2014
Study Start
December 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 27, 2017
Results First Posted
January 27, 2017
Record last verified: 2016-12