Status:
COMPLETED
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
- Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
- Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
- a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
- a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit
- Exclusion criteria:
- Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
- History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
- Positive serological test for hepatitis B or hepatitis C
Exclusion
Key Trial Info
Start Date :
September 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2016
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT02229383
Start Date
September 6 2014
End Date
August 29 2016
Last Update
January 8 2019
Active Locations (123)
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1
Research Site
Birmingham, Alabama, United States, 35235
2
Research Site
Huntsville, Alabama, United States, 35801
3
Research Site
Muscle Shoals, Alabama, United States, 35662
4
Research Site
Tempe, Arizona, United States, 85283