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

NCT02616666

CompletedPhase 4

Sponsor: University of Liverpool

Conditions: Type 2 Diabetes Mellitus

Interventions: Dapagliflozin, Standard of Care

Countries: United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

For inclusion in the study patients should fulfil the following criteria at the time of screening:

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

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous enrolment or randomization in the present study
3. Age \> 75 years
4. Pregnancy/active breast feeding at the time of inclusion
5. Known moderate to severe renal impairment (eGFR\<60ml/min).
6. Participation in an interventional clinical trial ≤ 3 months before enrolment.
7. Unsuitable to participate on mental health grounds, as judged by the investigator.
8. Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.
9. Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.

Locations (132)

Forfar, Angus, United Kingdom
Yate, Avon, United Kingdom
Bracknell, Berkshire, United Kingdom
Reading, Berkshire, United Kingdom
Wokingham, Berkshire, United Kingdom
Birmingham, Birmingham, United Kingdom
Maesteg, Bridgend, United Kingdom
Chew Stoke, Bristol, United Kingdom
Yate, Bristol, United Kingdom
Iver, Bucks, United Kingdom
Blackwood, Caerphilly, United Kingdom
Hengoed, Caerphilly, United Kingdom
Greenisland, Carrickfergus, United Kingdom
Whitehead, Carrickfergus, United Kingdom
Macclesfield, Cheshire, United Kingdom
Crook, County Durham, United Kingdom
Denbigh, Denbighshire, United Kingdom
Exeter, Devon, United Kingdom
Hull, East Yorkshire, United Kingdom
Romford, Essex, United Kingdom
Pinhoe, Exeter, United Kingdom
Cheltenham, Gloucestershire, United Kingdom
Trafford, Greater Manchester, United Kingdom
Worsley, Greater Manchester, United Kingdom
Alton, Hampshire, United Kingdom
Farnborough, Hampshire, United Kingdom
Gosport, Hampshire, United Kingdom
Havant, Hampshire, United Kingdom
Romsey, Hampshire, United Kingdom
Southampton, Hampshire, United Kingdom
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