Type 2 Diabetes Mellitus (T2DM)
Conditions
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'
Interventions
None listed
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month | Month 6 |
Secondary
| 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 |
| Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month | Month 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 |
| Change in Lantus® dose at the end of 3rd and 6th months | Month 3 and 6 |
Countries
France
Outcome results
None listed