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

Official title

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 identification

NCT ID

NCT02229396

Recruitment status

Completed

Study type

Interventional

Phase

Phase 3

Lead sponsor

AstraZeneca

Industry

Enrollment

695 participants

Conditions and interventions

Eligibility (public fields only)

Age range

18 Years to 130 Years

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Sep 4, 2014 (Actual)

Primary completion

Apr 26, 2016 (Actual)

Completion

Dec 28, 2017 (Actual)

Last update posted

Dec 31, 2018

2014 – 2017

United States locations

U.S. sites

76

U.S. states

22

U.S. cities

64

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.