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NCT01897532 · ClinicalTrials.gov registry record · Phase 4
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 6,991
- Enrollment target
NCT01897532: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT01897532 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 6,991 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1250% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01897532, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 6,991 participants
- Enrollment target
Study Summary
The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.
Primary Outcome
Time to event analysis of patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non-fatal stroke. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE) was reported.
Interventions
- DRUG Placebo
- DRUG Linagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,991 participants |
| Start Date | 2013-07-10 |
| Est. Completion | 2018-01-18 |
| Phase | Phase 4 |
What the finished NCT01897532 record still lists
NCT01897532 is an interventional study that assigns participants to a tested intervention. Its 6,991 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1250% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01897532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01897532 about?
NCT01897532 is a clinical study titled "Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)". The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.
What is the current status of trial NCT01897532?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 6,991 participants. The study started on 2013-07-10. Estimated completion is 2018-01-18.
What interventions are being tested in trial NCT01897532?
The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG).
Who is sponsoring clinical trial NCT01897532?
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 NCT01897532's enrollment target sits among peer trials
6,991 12th of 2000 higher than 1,989 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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