Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France

SGLT2i Use in France Based on SNDS Data Claim

The primary objective of this study are:

- Describe the characteristics of all patients initiating sodium-glucose co-transporter-2 inhibitors (SGLT2i) and the modalities of prescriptions of these two drugs and the concomitant treatments.

The secondary objectives are:

• Assess the occurrence of atheromatous cardiovascular events (unstable angina, fatal and non-fatal Myocardial infarction (MI), Transient ischemic attack (TIA), fatal and non-fatal stroke), deaths from all causes, hospitalization for heart failure and hospitalization for end-stage renal disease as main and related diagnoses during the exposure to the studied treatment
• Assess the occurrence of the main safety events (ketoacidosis, lower limb amputation and Fournier's gangrene) during the exposure to the studied treatment

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

• Study Type: Observational
• Enrollment (Estimated): 547150

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• France
  • Paris, France, 75013
    • Boehringer Ingelheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients in France initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.

Description

Inclusion Criteria:

• population includes all patients initiating a treatment with SGLT2i between April 1, 2020, and December 31, 2024.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients initiating treatment with SGLT2i	Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i); Sodium/glucose cotransporter-2 inhibitors (SGLT2i)
Type 2 diabetes mellitus patients initiating SGLT2i	Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i); Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline characteristic: Age	up to 5 years
Baseline characteristic: Gender	up to 5 years
Baseline characteristic: Region of residence	up to 5 years
Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)	up to 5 years
Baseline characteristic: Type of diabetes	up to 5 years
Proportion of patients with a history of cardio-vascular events including heart failure hospitalizations and lower limb amputation, renal events, ketoacidosis, Fournier's gangrene over the two years before the index date (initiation of SGLT2i)	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i	up to 5 years
Time from drug initiation to first event of acute cardiovascular atheromatous events	up to 5 years
Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i	up to 5 years
Time from drug initiation to first event of heart failure hospitalization	up to 5 years
Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i	up to 5 years
Time from drug initiation to death all cause	up to 5 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1245-0287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No