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

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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Data of T2DM patients consecutively included in the RNDR from January 2015 to October 2017 will be included in this retrospective analysis. New users will be defined as individuals with T2DM either receiving a prescription of a SGLT-2 inhibitor or other GLD during the study period. Individuals with a previous issued/dispensed prescription of that medicine class during the preceding 1 year are not defined as new users. The year of the first issued prescription of the included medication classes during the study period will be denoted the index year. The group of other GLD will include all diabetes medicines, allowing combinations and monotherapy use except use of SGLT-2 inhibitors. The class SGLT-2 inhibitors include mainly dapagliflozin, empagliflozin and canagliflozin.

Since SGLT-2 inhibitors are relatively recently introduced on the market the population size and follow-up time is limited. Approximately 22,000 patients registered in RNDR will be included.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1690R00048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No