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 Overview
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Brief Summary
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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.

Detailed Description
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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'

Official Title
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A Retrospective Descriptive Analysis Assessing the Treatment Persistence to Basal Insulin in Type 2 Diabetes Patients in a Structured Patient Education Program in India

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |