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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT03694470
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-15
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with co-morbidities	2015-2017	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.
Number of participants with abdominal laboratory values	2015-2017	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)

Trial Locations

Locations (1)

Research site; 🇷🇺 Moscow, Russian Federation