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

NCT02616666 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2026-02-20

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Clinical Practice Research Datalink

    collaborator OTHER_GOV

  • University of Liverpool

    lead OTHER

Principal Investigators

  • John Wilding, MBChB, DM · Universtiy of Liverpool, University Hospital, Aintree, Longmoor Lane, Liverpool, L9 7AL, UK

  • Jesús Medina, PhD · AstraZeneca

  • Susan Beatty, MSc · Clinical Practice Research Datalink

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-25
Primary Completion
2025-12-12
Completion
2025-12-12

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616666 on ClinicalTrials.gov