NCT02971618

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
929

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2018

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

November 21, 2016

Last Update Submit

August 2, 2019

Conditions

Diabetes Mellitus Type 2

Keywords

dapagliflozin,Russia,retrospective study,diabetes mellitus type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycosylated haemoglobin)

    To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up

    3 months

Secondary Outcomes (7)

  • reduction of HbA1c by 0.5% or more

    3 months

  • (%) of patients reaching the therapeutic glycemic response (HbA1c <7.0%)

    3 months

  • change of fasting blood glucose

    3 months

  • change of body weight

    3 months

  • percentage (%) of patients with body weight reduction by at least 5%

    3 months

  • +2 more secondary outcomes

Study Arms (1)

Total group

Patients T2D with dapagliflozin treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

T2DM patients previously uncontrolled on standard therapy (mono-, double therapy with OADs: metformin, SU or DPP-4 inhibitors or on insulin) initiating treatment with dapagliflozin as monotherapy, combination with OADs or as add-on to insulin with available data on Hb1c within 3 months prior to the first dose of dapagliflozin. All consecutive patients at the clinic in inclusion period who meet inclusion and exclusion criteria will be included.

You may qualify if:

  • Patients with Type 2 Diabetes Mellitus Male and female, age 18-65 years (both inclusive) Patients with T2DM given a first prescription for dapagliflozin after Dec 2014 till 1 October 2016

You may not qualify if:

  • Type 1 diabetes Contraindications for SGLT 2 inhibitors (high individual sensitivity to SGLT 2 inhibitors, T1DM, diabetic ketoacidosis, moderate and severe renal failure (eGFR \< 60 ml/min/1.73 m3), end-stage renal disease, lactose intolerance, intolerance of glucose and galactose, pregnancy and breast feeding, age younger than 18 years old, use of loop diuretics, decrease of circulating blood volume due to acute disease, age of 77 years old and older Prior use of SGLT 2 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vladimir Bulatov

    AstraZeneca

    STUDY DIRECTOR

  • Mikhail Antsiferov, Prof.

    Moscow endocrinology dispensary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 23, 2016

Study Start

February 21, 2017

Primary Completion

August 3, 2018

Study Completion

August 3, 2018

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

RU(2)