Clinical trial NCT02288273: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in 24-hour Mean Weighted Glucose
timeFrame: Day 27/28
Secondary outcomes:
measure: 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
timeFrame: Day 64/65
measure: Change From Baseline (Day1) to Day 70 and Day 22 in FPG
timeFrame: Day 22/Day70
measure: Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
timeFrame: Day 22 and Day 64
measure: Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
timeFrame: Week 4 and Week 10
measure: Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
timeFrame: Day 22 and Day 70
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Chino
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: North Hollywood
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Tustin
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Edina
country: United States
facility: Research Site
state: Minnesota
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: Butte
country: United States
facility: Research Site
state: Montana
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Franklin
country: United States
facility: Research Site
state: Ohio
city: Marion
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Mt Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Katy
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Olympia
country: United States
facility: Research Site
state: Washington
Study officials:
References: