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

Study identifier:D1690R00009

ClinicalTrials.gov identifier:NCT02616666

EudraCT identifier:2015-001873-42

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 4

Healthy volunteers

Study drug

Dapagliflozin, Standard of Care

Sex

All

Estimated Enrollment

872

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 25 Aug 2016

Estimated Primary Completion Date: 01 Apr 2023

Estimated Study Completion Date: 01 Apr 2023

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2018 by AstraZeneca

Collaborators

Quintiles, Clinical Practice Research Datalink (CPRD)

Inclusion and exclusion criteria

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Dapagliflozin 10 mg Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.	Drug: 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. Other Name: FORXIGA
Active Comparator: Standard of Care (SOC) Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.	Drug: 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

Assigned Interventions

Experimental: Dapagliflozin 10 mg
Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.

Drug: 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.

Other Name: FORXIGA

Active Comparator: Standard of Care (SOC)
Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.

Drug: 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.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Jesús Medina

AstraZeneca