NCT05882071

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547,150

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Nov 2023Jul 2026

First Submitted

Initial submission to the registry

May 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

May 22, 2023

Last Update Submit

January 6, 2026

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Patients initiating treatment with SGLT2i

Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Type 2 diabetes mellitus patients initiating SGLT2i

Drug: Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Interventions

Sodium/glucose cotransporter-2 inhibitors (SGLT2i)DRUG

Sodium/glucose cotransporter-2 inhibitors (SGLT2i)

Patients initiating treatment with SGLT2iType 2 diabetes mellitus patients initiating SGLT2i

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim

Paris, 75013, France

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

May 31, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

FR(1)