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
PERSISTENT
A retrosPective Descriptive Analysis Assessing the trEatment peRsistence to baSal InSulin in Type 2 diabEtes patieNTs in a Structured Patient Education Program in India
3 other identifiers
observational
47,885
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedMarch 8, 2024
March 1, 2024
1.1 years
November 16, 2022
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month
Month 6
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- Male or female aged ≥ 18 years
- T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Investigational Site Number :
Chilly-Mazarin, 91380, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 28, 2022
Study Start
November 30, 2022
Primary Completion
December 29, 2023
Study Completion
December 29, 2023
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
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