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

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; University of Liverpool
• Collaborators: AstraZeneca; Clinical Practice Research Datalink; Quintiles, Inc.
• Treatments: Dapagliflozin

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.