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

Type 2 Diabetes Clinical Trial

Official title:

Retrospective Study to Describe Characteristics of Patients With Type 2 Diabetes Mellitus Who Were Initiating Use or Treatment With Sodium-glucose Co-transporter-2 Inhibitors and Other Diabetes Medications (Other Glucose Lowering Drugs) in 2015-17 Based on National Russian Diabetes Registry Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694470
• Other study ID #: D1690R00048
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Russian Federation	Research site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2015-2017
Secondary	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)	2015-2017
Secondary	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.	2015-2017

External Links

•   CSR Synopsis