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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 127
Updated:1/2/2019
Start Date:September 4, 2014
End Date:December 28, 2017

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A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

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.


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.
We found this trial at
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