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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

— PERSISTENT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628090
• Other study ID #: LANTUL09644
• Secondary ID: U1111-1280-5131P
• Status: Completed
• Start date: November 30, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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'

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47885
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Locations

Country	Name	City	State
France	Investigational Site Number :	Chilly-Mazarin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month		Month 6
Secondary	Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month		Month 3
Secondary	Proportion of patients persisting on Lantus® at the end of 3rd and 6th months		Month 3 and 6
Secondary	Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months		Month 3 and 6
Secondary	Change in Lantus® dose at the end of 3rd and 6th months		Month 3 and 6
Secondary	Change in Toujeo® dose at the end of 3rd and 6th months		Month 3 and 6
Secondary	Proportion of patients on Lantus® who switched to other therapy at the end of 6th month		Month 6
Secondary	Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month		Month 6