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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 241 participants.

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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).

Interventions

  • DRUG Placebo
  • DRUG Linagliptin
  • DRUG Glimepiride

Trial Details

FieldValue
Enrollment Target 241 participants
Start Date 2010-03
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01087502

The ClinicalTrials.gov registry entry for NCT01087502 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01087502 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.