Clinical trial NCT05628090: 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-11-28
Enrollment: 47885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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'

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month
timeFrame: Month 6
Secondary outcomes:
measure: Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month
timeFrame: Month 3
measure: Proportion of patients persisting on Lantus® at the end of 3rd and 6th months
timeFrame: Month 3 and 6
measure: Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months
timeFrame: Month 3 and 6
measure: Change in Lantus® dose at the end of 3rd and 6th months
timeFrame: Month 3 and 6
measure: Change in Toujeo® dose at the end of 3rd and 6th months
timeFrame: Month 3 and 6
measure: Proportion of patients on Lantus® who switched to other therapy at the end of 6th month
timeFrame: Month 6
measure: Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month
timeFrame: Month 6
Other outcomes:
Locations:
city: Chilly-Mazarin
country: France
facility: Investigational Site Number :
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: