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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Exantide with Dapagliflozin; Drug: Dapagliflozin; Drug: Exentide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02229396

2014-003503-29 (EudraCT Number)

D5553C00003

Details and patient eligibility

About

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.

Enrollment: 695 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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695 participants in 3 patient groups

Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg

Experimental group

Treatment:

Drug: Exantide with Dapagliflozin

Exenatide Once Weekly 2 mg Alone

Experimental group

Treatment:

Drug: Exentide

Dapagliflozin Once Daily 10 mg Alone

Active Comparator group

Treatment:

Drug: Dapagliflozin