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Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bydureon
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bydureon

Placebo

Arm Description

Once weekly injected exenatide

Placebo comparator

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70

Full Information

First Posted
November 7, 2014
Last Updated
December 5, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02288273
Brief Title
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (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
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.
Detailed Description
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bydureon
Arm Type
Experimental
Arm Description
Once weekly injected exenatide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
Bydureon
Other Intervention Name(s)
exenatide
Intervention Description
Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in 24-hour Mean Weighted Glucose
Description
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).
Time Frame
Day 27/28
Secondary Outcome Measure Information:
Title
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
Time Frame
Day 64/65
Title
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Time Frame
Day 22/Day70
Title
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Time Frame
Day 22 and Day 64
Title
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Time Frame
Week 4 and Week 10
Title
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Time Frame
Day 22 and Day 70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Chino
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
North Hollywood
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Research Site
City
Spring Valley
State/Province
California
Country
United States
Facility Name
Research Site
City
Tustin
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
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
Franklin
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Marion
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Mt Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Research Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Katy
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
Burke
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Manassas
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

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