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

NCT02719132 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-05-20

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Dapagliflozin

Dapagliflozin, 10 mg

DRUG

Metformin

Metformin, up to 2500 mg

Sponsors & Collaborators

Principal Investigators

  • Marina Shestakova, Professor · Russian Federal Research Endocrinology center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-11-30
Completion
2017-11-30

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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 NCT02719132 on ClinicalTrials.gov