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

NCT02229396 · Completed

Last updated 2026-05-28

This clinical trial tested the effects of two diabetes medications, exenatide once weekly and dapagliflozin, compared to placebos, in adults with diabetes over 28 weeks, with additional follow-up periods.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 695 people

Who can join Ages 18–130 · all sexes

Timeline Started 2014-09 · est. completion 2017-12

Where 133 sites · Hungary, Poland, Romania, Slovakia, South Africa, United States

What this study is testing ClinicalTrials.gov NCT02229396 ↗

Description as written by the study sponsor.

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.

Treatments tested

Exantide with Dapagliflozin Drug

2 mg weekly suspension injection and 10 mg Dapagliflozin
Exentide Drug

2 mg
Dapagliflozin Drug

10 mg once daily Dapagliflozin

Main thing measured	Change in HbA1c From Baseline to Week 28
Sponsor	AstraZeneca
Conditions studied	Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02229396 ↗