Type 2 Diabetes Mellitus (T2DM) Clinical Trial
— PERSISTENTOfficial 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
Verified date | March 2024 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Investigational Site Number : | Chilly-Mazarin |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
France,
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 |
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