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

StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later across 3 updates Jul 31, 2026 → Nov 30, 2026
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Record History

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  1. Primary and study completion pushed from Oct 23, 2026 to Nov 30, 2026
  2. Primary endpoints: details revised at 1 of 6 entries
    • Primary and study completion pushed from Aug 31, 2026 to Oct 23, 2026
    • Interventions: Sodium/glucose cotransporter-2 inhibitors (SGLT2i) (Drug) to Sodium/glucose cotransporter-2 inhibitors (SGLT2i) (Drug)
    • Eligibility criteria expanded, about 2 words
  3. Primary and study completion pushed from Jul 31, 2026 to Aug 31, 2026v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary and study completion dates: Jun 30, 2026 to Jul 31, 2026v11
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  1. Primary and study completion dates: Dec 30, 2025 to Jun 30, 2026v10
  2. Enrollment target: 50000 to 547150v9
  3. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2023 to Nov 15, 2023
    v8
  4. Primary and study completion dates: Dec 31, 2025 to Dec 30, 2025v7
  5. Start date: Nov 16, 2023 to Dec 30, 2023v6
  6. Start date: Oct 16, 2023 to Nov 16, 2023v5
  7. Re-verified, no change to tracked fieldsv4
  8. Start date: Jun 15, 2023 to Oct 16, 2023v3
  9. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Boehringer Ingelheim
223 trials monitored
See 11 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Type 2 Diabetes
2,236 trials monitored
See 113 trials at risk
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 Details
NCT Number NCT05882071
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2
Enrollment 547,150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov