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

NCT03694470 | Completed

• 1 other identifier: D1690R00048
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants with abdominal laboratory values

  2015-2017

• Number of participants with co-morbidities

  2015-2017

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research site

Moscow, Russia

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: October 3, 2018
• Study Start: April 15, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

RU (1)