Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

NCT02229383 · Completed

Last updated 2026-05-28

This clinical trial tested whether adding the medication exenatide to insulin glargine helps lower blood sugar levels in adults with type 2 diabetes who are not well-controlled.

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 464 people

Who can join Ages 18–130 · all sexes

Timeline Started 2014-09 · est. completion 2016-08

Where 123 sites · Hungary, Poland, Romania, Slovakia, South Africa, United States

What this study is testing ClinicalTrials.gov NCT02229383 ↗

Description as written by the study sponsor.

Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Treatments tested

Exenatide Drug

2 mg weekly suspension injection
Exenatide matching placebo Drug

Once weekly Placebo injection

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 NCT02229383 ↗