Effect of DapagliFLOzin on Quality of Life in Patients With Type 2

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

The study will comprise the following phases: Screening, Treatment Period 1 and Treatment Period 2.

After screening examinations and assessments, all patients enrolled will be randomly assigned in equal proportion (1:1) to either study arm:

Arm 1:

- Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks during Treatment Period 1

- Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks during Treatment Period 2

Arm 2 (the same treatment phases in reverse order):

- Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks during Treatment Period 1

- Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks during Treatment Period 2 Following the randomisation procedure, patients will receive investigational products at each visit as scheduled by Treatment Period 1. After the Randomisation Visit (Visit 2), the patient should attend the study centre for Visits 3, 4, and 5 (Day 28, Day 86, and Day 168, respectively) for efficacy and safety assessments. At Visit 5 (Day 168), the patient will receive investigational products as required by Treatment Period 2. Further Visits 6, 7 and 8 will be scheduled on Day 196, Day 252, Day 336, respectively. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02719132
Study type	Interventional
Source	AstraZeneca
Contact
Status	Withdrawn
Phase	Phase 4
Start date	July 2016
Completion date	November 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms