Status:
COMPLETED
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of e...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Has a diagnosis of T2DM.
- Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
- Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.
- Exclusion criteria
- FPG ≥280 mg/dL (15.6 mmol/L).
- Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
- Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
- Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
- Known active proliferative retinopathy.
- History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
- History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
- History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
Exclusion
Key Trial Info
Start Date :
September 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2017
Estimated Enrollment :
695 Patients enrolled
Trial Details
Trial ID
NCT02229396
Start Date
September 4 2014
End Date
December 28 2017
Last Update
December 31 2018
Active Locations (133)
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1
Research Site
Birmingham, Alabama, United States, 35235
2
Research Site
Huntsville, Alabama, United States, 35801
3
Research Site
Tuscumbia, Alabama, United States, 35674
4
Research Site
Glendale, Arizona, United States, 85306