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Completed

NCT Number: NCT05628090

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number :

Chilly-Mazarin, 91380, France

About this study

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'

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month

    Time frame: Month 6

Secondary outcomes

  1. Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month

    Time frame: Month 3

  2. Proportion of patients persisting on Lantus® at the end of 3rd and 6th months

    Time frame: Month 3 and 6

  3. Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months

    Time frame: Month 3 and 6

  4. Change in Lantus® dose at the end of 3rd and 6th months

    Time frame: Month 3 and 6

  5. Change in Toujeo® dose at the end of 3rd and 6th months

    Time frame: Month 3 and 6

  6. Proportion of patients on Lantus® who switched to other therapy at the end of 6th month

    Time frame: Month 6

  7. Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A retrosPective Descriptive Analysis Assessing the trEatment peRsistence to baSal InSulin in Type 2 diabEtes patieNTs in a Structured Patient Education Program in India

Acronym: PERSISTENT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 28, 2022
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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