Characteristics of Patients With Type 2 Diabetes Mellitus (CVD-RNDR)

AstraZeneca10,000 enrolled

Overview

This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Type 2 Diabetes

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria are: * New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups; * T2DM diagnosis on or prior to the index year; * ≥ 18 years old at index year. Exclusion criteria are: * Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index; * Patients with a gestational diabetes in the index year or 1 year prior to index.

Locations (1)

Research site

Moscow, Russia

Outcomes

Primary Outcomes

The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017

The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016 2017 among T2DM patients initiated use of antidiabetic treatment in these years according to Russian National Diabetes Registry data.

Time frame: 2015-2017

Secondary Outcomes

Number of participants with abdominal laboratory values

Number of participants with abdominal laboratory values glycosylated haemoglobin (Hb1Ac), total Cholesterol, low Density Lipids (LDL), high Density Lipids (HDL), creatinine, estimated Glomerular Filtration Rate (EGFR)

Time frame: 2015-2017

Number of participants with co-morbidities

Number of participants with co-morbidities: myocardial infarction (MI), stroke (ischemic or hemorrhagic )Transient Ischemic Attack (TIA)Peripheral Artery Disease (PAD), Heart Failure, Hypertension, Hyperlipidemia, Neuropathy, Nephropathy, Retinopathy, Therapies, Diabetes medications, Hypertension medications, Diuretics, Lipid lowering drugs, Anti-platelets.

Time frame: 2015-2017

Data from ClinicalTrials.gov

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