A Pragmatic Randomized Trial to Evaluate the Comparative... | NCT02616666

ID	Type	Description	Link
2015-001873-42	EudraCT Number

Status Module

Name	Class
AstraZeneca	INDUSTRY
Clinical Practice Research Datalink	OTHER_GOV

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin 10 mg	Experimental	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
Standard of Care (SOC)	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.	Proportion of patients achieving clinical success as measured by a 4-item composite endpoint including HbA1c reduction vs. baseline (≥ 0.5%), weight loss vs. baseline (≥ 2 Kg), no reported severe or documented hypoglycaemic events since randomization, and no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC),at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).	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).

Secondary Outcomes

Measure	Description	Time Frame
HbA1c success (HbA1c reduction vs. baseline ≥ 0.5%) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).	HbA1c reduction	From randomization to 104 weeks of follow up.
Weight loss success (weight vs. baseline ≥ 2 Kg) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
John Wilding, MBChB, DM	Universtiy of Liverpool, University Hospital, Aintree, Longmoor Lane, Liverpool, L9 7AL, UK	Principal Investigator
Jesús Medina, PhD	AstraZeneca	Study Director
Susan Beatty, MSc	Clinical Practice Research Datalink	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Forfar	Angus		United Kingdom
Research Site

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation