CompletedPhase 4

A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients

United Kingdom632 participantsStarted 2016-08-25

Plain-language summary

A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of informed consent prior to any study specific procedures
. Females and males aged ≥18 years up to ≤ 75 years
. Diagnosed with Type 2 Diabetes Mellitus.
. Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c \> 6.5%.
. Ability to read and write as judged by the investigator.

Exclusion criteria

. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
. Previous enrolment or randomization in the present study
. Age \> 75 years
. Pregnancy/active breast feeding at the time of inclusion
. Known moderate to severe renal impairment (eGFR\<60ml/min).
. Participation in an interventional clinical trial ≤ 3 months before enrolment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.

Timeframe: Assessment of outcome measure will be made at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).

Trial details

NCT IDNCT02616666

SponsorUniversity of Liverpool

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-12

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials