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)

A retrosPective Descriptive Analysis Assessing the trEatment peRsistence to baSal InSulin in Type 2 diabEtes 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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM)

Detailed 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'

• Study Type: Observational
• Enrollment (Actual): 47885

Contacts and Locations

Study Locations

• France
  • Chilly-Mazarin, France, 91380
    • Investigational Site Number :

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Data will be analyzed for all T2DM patients ≥ 18 years of age, enrolled in the SAATH-7 Star program from March 2019 to August 2019, with a treatment length of 6 months.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month	Month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month	Month 3
Proportion of patients persisting on Lantus® at the end of 3rd and 6th months	Month 3 and 6
Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months	Month 3 and 6
Change in Lantus® dose at the end of 3rd and 6th months	Month 3 and 6
Change in Toujeo® dose at the end of 3rd and 6th months	Month 3 and 6
Proportion of patients on Lantus® who switched to other therapy at the end of 6th month	Month 6
Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month	Month 6

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

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: LANTUL09644; U1111-1280-5131 (Registry Identifier: ICTRP); PDE0043 (Other Identifier: Sanofi Identifier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

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