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
• Trial end date: 2017-12-28
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Exenatide

Criteria

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.