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

Completed · Phase 3

Conditions studied: Diabetes Mellitus

In brief

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 exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Key facts

Study ID

NCT02229396

Run by

AstraZeneca

People needed

695

Starts

2014-09-04

Expected to finish

2017-12-28

Last updated by the study team

2018-12-31

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Tuscumbia, Alabama, United States
• Research Site — Glendale, Arizona, United States
• Research Site — Tempe, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — El Cajon, California, United States
• Research Site — Fresno, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Hills, California, United States
• Research Site — Montclair, California, United States
• Research Site — Oceanside, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — Tustin, California, United States
• Research Site — Van Nuys, California, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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