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A Study of an Existing Database to Assess the Treatment Persistence to Basal Insulin in Type 2 Diabetes Mellitus Patients in a Structured Patient Education Program in India (PERSISTENT)

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Sanofi

Status

Completed

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study type

Observational

Funder types

Industry

Identifiers

NCT05628090
PDE0043 (Other Identifier)
U1111-1280-5131 (Registry Identifier)
LANTUL09644

Details and patient eligibility

About

The aim of this study is to analyze data from an existing database named SAATH-7 Star, in order to assess the treatment persistence to basal insulin in Type 2 diabetes patients who had been enrolled in the SAATH-7 Star structured patient education program in India.

Full description

This retrospective study will involve secondary analysis of already existing data of Indian T2DM patients who were administered subcutaneous injectable solutions of insulin glargine (Lantus® or Toujeo®), as per routine clinical practice and who were enrolled in a structured educational program named SAATH-7 Star. Six-months data for eligible patients, who were enrolled in the SAATH-7 Star Program during the index period of March 2019-August 2019, collected from the SAATH-7 Star database will be analyzed for the defined objectives. The index date is defined as the date of enrollment in SAATH-7 Star program i.e. 1st month, which will also be considered as the 'Baseline'

Enrollment

47,885 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female aged ≥ 18 years
  • T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019

Exclusion criteria

  • Type 1 diabetes patients
  • Patients with gestational diabetes

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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