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NCT01243424 · ClinicalTrials.gov registry record · Phase 3
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,103
- Enrollment target
NCT01243424: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01243424 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 6,103 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (691% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243424, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,103 participants
- Enrollment target
Study Summary
The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.
Primary Outcome
The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
Interventions
- DRUG linagliptin
- DRUG glimepiride
- DRUG linagliptin placebo
- DRUG glimepiride placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,103 participants |
| Start Date | 2010-11-11 |
| Est. Completion | 2018-08-21 |
| Phase | Phase 3 |
What the finished NCT01243424 record still lists
NCT01243424 is an interventional study that assigns participants to a tested intervention. Its 6,103 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (691% higher).
The record links to 0 conditions, and to 4 interventions - of which linagliptin is the first listed.
NCT01243424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01243424 about?
NCT01243424 is a clinical study titled "CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes". The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk r...
What is the current status of trial NCT01243424?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,103 participants. The study started on 2010-11-11. Estimated completion is 2018-08-21.
What interventions are being tested in trial NCT01243424?
The interventions under investigation include: linagliptin (DRUG), glimepiride (DRUG), linagliptin placebo (DRUG), glimepiride placebo (DRUG).
Who is sponsoring clinical trial NCT01243424?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01243424's enrollment target sits among peer trials
6,103 36th of 2000 higher than 1,965 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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