For Healthcare Professionals

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

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About the study

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

You may be eligible to participate in the study if you meet the following 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Type 2 Diabetes Mellitus,Dry Eye

Phase

Phase 4

Participants needed

632

Est. Completion Date

Jun 2023

Treatment type

Interventional


Sponsor

University of Liverpool

ClinicalTrials.gov identifier

NCT02616666

Study number

D1690R00009

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