Last updated on January 2019

A Pragmatic Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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