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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1280-5131 | Registry Identifier | ICTRP | |
| PDE0043 | Other Identifier | Sanofi Identifier |
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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.
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'
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month | Month 6 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : | Chilly-Mazarin | 91380 | France |
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
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| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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