Clinical trial
A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)
Name
D1690R00009
Description
A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)
Trial arms
Trial start
2016-08-25
Estimated PCD
2024-07-31
Trial end
2024-07-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Dapagliflozin
The product in study is dapagliflozin (FORXIGA™), 10 mg film-coated tablets, and FORXIGA™ should be prescribed according to the instructions in the SmPC and current practice, including up-titration (if considered appropriate by the investigator). Dapagliflozin will be given in combination with metformin.
Arms:
Dapagliflozin 10 mg
Other names:
FORXIGA
Standard of Care
The comparator arm consists of SOC. The SOC arm can be sulphonylurea (SU) or non-SU treatments. SU treatments will include any SU and the related insulin secretagogues repaglinide or nateglinide, each of them in combination with metformin. The non-SU treatments can be metformin and dipeptidyl peptidase 4 inhibitors (DPP-4i), or metformin and glitazones (pioglitazone) combination therapy. Other SGLT-2 inhibitors are excluded. All these treatments are approved in the UK for use in this patient population.
Arms:
Standard of Care (SOC)
Size
632
Primary endpoint
Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.
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).
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 632, 'type': 'ACTUAL'}}
Updated at
2023-12-05
1 organization
1 product
1 drug
1 indication
Organization
University of LiverpoolDrug
DapagliflozinIndication
Type 2 Diabetes MellitusProduct
Standard of Care