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Study With Dapagliflozin

NCT02971618 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 929

Last updated 2019-08-06

No results posted yet for this study

Summary

The study will retrospectively collect clinical variables and socio-demographic data from medical records of patients with T2DM initiating treatment with dapagliflozin after the previous failure/inefficiency of other treatment options (defined as non-achievement of target Hb1Ac) and according to the officially approved indication as per instruction for the use of medicinal product.

It is expected that the best available data regarding clinical variables and patient socio-demographic profiled will be collected from the patient medical records at up to 40 major Russian outpatient clinics/centers specialized in the treatment and management of T2DM patients.

There are 2 time points:

* Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
* Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6 plus/minus 3 months after the initiation of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose

Conditions

  • Diabetes Mellitus Type 2

Sponsors & Collaborators

Principal Investigators

  • Vladimir Bulatov · AstraZeneca

  • Mikhail Antsiferov, Prof. · Moscow endocrinology dispensary

Eligibility

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

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2018-08-03
Completion
2018-08-03

Countries

  • Russia

Study Locations

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Entities

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 NCT02971618 on ClinicalTrials.gov