Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice

Sponsor
AstraZeneca
Study ID
NCT02719132
Phase
PHASE4
Status
Withdrawn

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin, 10 mg
  • Metformin — DRUG
    Metformin, up to 2500 mg

Study Details

This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV study. The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.

Key Dates

Start date
Jul 31, 2016
Status verified
May 2016
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Arm 1 - therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks (Treatment Regimen 1) followed by metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks (Treatment Regimen 2)
  • Active Comparator: Arm 2
    Arm 2 - metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks (Treatment Regimen 2) followed by therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks (Treatment Regimen 1)

Primary Outcome Measure

Composite endpoint including quality of life score [ Time Frame: 48 weeks ]

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