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NCT Number: NCT05882071

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Drug

Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Primary outcomes

  1. Baseline characteristic: Age

    Time frame: up to 5 years

  2. Baseline characteristic: Gender

    Time frame: up to 5 years

  3. Baseline characteristic: Region of residence

    Time frame: up to 5 years

  4. Baseline characteristic: History of diabetes (date of first Long Term Disease (LTD) status related to diabetes)

    Time frame: up to 5 years

  5. Baseline characteristic: Type of diabetes

    Time frame: up to 5 years

  6. 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)

    Time frame: up to 5 years

Secondary outcomes

  1. Incidence rate of acute cardiovascular atheromatous events during the exposure period following initiation of the SGLT2i

    Time frame: up to 5 years

  2. Time from drug initiation to first event of acute cardiovascular atheromatous events

    Time frame: up to 5 years

  3. Incidence rate of heart failure hospitalization during the exposure period following initiation of the SGLT2i

    Time frame: up to 5 years

  4. Time from drug initiation to first event of heart failure hospitalization

    Time frame: up to 5 years

  5. Incidence rate of deaths all cause during the exposure period following initiation of the SGLT2i

    Time frame: up to 5 years

  6. Time from drug initiation to death all cause

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

SGLT2i Use in France Based on SNDS Data Claim

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 31, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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