deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01243424

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

Sponsor: Boehringer Ingelheim

Conditions Diabetes Mellitus, Type 2
Interventions glimepiride glimepiride placebo linagliptin linagliptin placebo
Updated 15 times since 2017 Last updated: Dec 19, 2019 Started: Nov 11, 2010 Primary completion: Aug 21, 2018 Completion: Aug 21, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01243424, this PHASE3 trial focuses on Diabetes Mellitus, Type 2 and remains completed. Sponsored by Boehringer Ingelheim, it has been updated 15 times since 2010, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Mar 2017 · 59 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Dec 2017 · 7 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Oct 2018 · 3 months · monthly snapshot~Oct 2018 – ~Mar 2019 · 5 months · monthly snapshot~Mar 2019 – ~Aug 2019 · 5 months · monthly snapshot~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 6 months · monthly snapshot

Change History

15 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 10 earlier versions

  1. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Aug 2019 — Feb 2020 [monthly]

    Completed PHASE3

  3. Mar 2019 — Aug 2019 [monthly]

    Completed PHASE3

  4. Oct 2018 — Mar 2019 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Jul 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE3

  7. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  8. May 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

  9. Mar 2017 — May 2017 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2017 — Mar 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Nov 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
  • Eli Lilly and Company
Data source: Boehringer Ingelheim

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

's-Hertogenbosch, Netherlands , Aachen, Germany , Acapulco, Mexico , Addlestone, United Kingdom , Adelaide, Australia , Aguascalientes, Mexico , Ahmedabad, India , Aichi, Nagoya, Japan , Ajka, Hungary , Akron, United States and 483 more locations