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
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Registration Number
- NCT05628090
- Lead Sponsor
- Sanofi
- Brief 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.
- 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'
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47885
- Male or female aged ≥ 18 years
- T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month Month 6
- Secondary Outcome Measures
Name Time Method Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month Month 3 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 persisting on Lantus® at the end of 3rd and 6th months Month 3 and 6 Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month Month 6
Trial Locations
- Locations (1)
Investigational Site Number :
🇫🇷Chilly-Mazarin, France