Type 2 Diabetes Mellitus (T2DM)PERSISTENTNCT05628090
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
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Sanofi at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- How many people
- 47,885 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2022to 29 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or female aged ≥ 18 years
- T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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'
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month
Measured: Month 6
Secondary outcomes (7)
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month
Measured: Month 3
Proportion of patients persisting on Lantus® at the end of 3rd and 6th months
Measured: Month 3 and 6
Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months
Measured: Month 3 and 6
Change in Lantus® dose at the end of 3rd and 6th months
Measured: Month 3 and 6
Change in Toujeo® dose at the end of 3rd and 6th months
Measured: Month 3 and 6
Proportion of patients on Lantus® who switched to other therapy at the end of 6th month
Measured: Month 6
Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start30 Nov 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47,885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628090
- Sponsor's protocol ID
- LANTUL09644
- Other IDs
- U1111-1280-5131, PDE0043
- Acronym
- PERSISTENT
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05628090
- Acronym / sponsor ID
- PERSISTENT / LANTUL09644
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47,885 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female aged ≥ 18 years
- T2DM patients enrolled in SAATH-7 Star program during the index period from March 2019 to August 2019
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month
Time frame: Month 6
7 secondary outcomes
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 3rd month
Time frame: Month 3
Proportion of patients persisting on Lantus® at the end of 3rd and 6th months
Time frame: Month 3 and 6
Proportion of patients persisting on Toujeo® at the end of 3rd and 6th months
Time frame: Month 3 and 6
Change in Lantus® dose at the end of 3rd and 6th months
Time frame: Month 3 and 6
Change in Toujeo® dose at the end of 3rd and 6th months
Time frame: Month 3 and 6
Proportion of patients on Lantus® who switched to other therapy at the end of 6th month
Time frame: Month 6
Proportion of patients on Toujeo® who switched to other therapy at the end of 6th month
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients persisting on insulin glargine (Lantus® or Toujeo®) at the end of 6th month (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.