PERSISTENT: 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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month [Month 6]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female aged ≥ 18 years
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T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019
Exclusion Criteria:
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Type 1 diabetes patients
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Patients with gestational diabetes
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number : | Chilly-Mazarin | France | 91380 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LANTUL09644
- U1111-1280-5131