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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288273
• Other study ID #: D5551L00006
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2014
• Last updated: September 24, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Bydureon
Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Research Site	Anaheim	California
United States	Research Site	Burke	Virginia
United States	Research Site	Butte	Montana
United States	Research Site	Chicago	Illinois
United States	Research Site	Chino	California
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Edina	Minnesota
United States	Research Site	Franklin	Ohio
United States	Research Site	Houston	Texas
United States	Research Site	Katy	Texas
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Los Angeles	California
United States	Research Site	Manassas	Virginia
United States	Research Site	Marietta	Georgia
United States	Research Site	Marion	Ohio
United States	Research Site	Miami	Florida
United States	Research Site	Mt Pleasant	South Carolina
United States	Research Site	North Hollywood	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olympia	Washington
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Port Orange	Florida
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Santa Ana	California
United States	Research Site	Spring Valley	California
United States	Research Site	St Louis	Missouri
United States	Research Site	Tustin	California
United States	Research Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour mean weighted glucose	Distance traveled and other the other measures of energy will be calculated	Week 10	No
Primary	Change in 24-hour mean weighted glucose	Change in 24-hour mean weighted glucose	Baseline to Day 69/70 and to Day 27/28	No
Secondary	Change in 24-hour mean weighted glucose	Change in 24-hour mean weighted glucose within each extended-release formulation of exenatide (EQW)-treated patient	Day 64/65 and Day 69/70	No
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline in FPG	Baseline, Day 70 and Day 28	No
Secondary	Change in 2-hour mean weighted Postprandial Glucose (PPG)	Change from baseline in 2-hour mean weighted PPG	Baseline, Day 69 and Day 27	No
Secondary	Change in 24-hour mean weighted glucose	Average of change in 24-hour mean weighted glucose from baseline to Days 1 to 6 of Week 10 and Week 4 calculated.	Baseline to Days 1 to 6 of Week 10 and Week 4	No
Secondary	Change in 2-hour mean weighted PPG	Change from baseline to Day 69 and Day 27 in 2-hour mean weighted PPG	Baseline, Day 69 and Day 27	No