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NCT01087502 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
NCT01087502: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01087502 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 241 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087502, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
Primary Outcome
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
Interventions
- DRUG Placebo
- DRUG Linagliptin
- DRUG Glimepiride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2010-03 |
| Phase | Phase 3 |
What the finished NCT01087502 record still lists
NCT01087502 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01087502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01087502 about?
NCT01087502 is a clinical study titled "Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment". The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic contr...
What is the current status of trial NCT01087502?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2010-03.
What interventions are being tested in trial NCT01087502?
The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG), Glimepiride (DRUG).
Who is sponsoring clinical trial NCT01087502?
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 NCT01087502's enrollment target sits among peer trials
241 1272nd of 2000 higher than 728 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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