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NCT00819091 · ClinicalTrials.gov registry record · Phase 3

Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
245
Enrollment target
20
Study locations

NCT00819091 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 245 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00819091, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
245 participants
Enrollment target
20
Study locations

Study Summary

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG BI 1356

Study Locations (20)

Other

  • 1218.35.54003 Boehringer Ingelheim Investigational Site - Capital Federal
  • 1218.35.54005 Boehringer Ingelheim Investigational Site - Corrientes
  • 1218.35.54001 Boehringer Ingelheim Investigational Site - Mar del Plata
  • 1218.35.54006 Boehringer Ingelheim Investigational Site - Parque Velez Sarfield
  • 1218.35.36001 Boehringer Ingelheim Investigational Site - Budapest
  • 1218.35.36002 Boehringer Ingelheim Investigational Site - Budapest
  • 1218.35.36004 Boehringer Ingelheim Investigational Site - Budapest

California

  • 1218.35.10001 Boehringer Ingelheim Investigational Site - Los Angeles
  • 1218.35.10016 Boehringer Ingelheim Investigational Site - National City

Florida

  • 1218.35.10017 Boehringer Ingelheim Investigational Site - Fort Lauderdale
  • 1218.35.10021 Boehringer Ingelheim Investigational Site - Fort Lauderdale

Texas

  • 1218.35.10009 Boehringer Ingelheim Investigational Site - Dallas
  • 1218.35.10019 Boehringer Ingelheim Investigational Site - Sugar Land

Alabama

  • 1218.35.10002 Boehringer Ingelheim Investigational Site - Birmingham

Illinois

  • 1218.35.10013 Boehringer Ingelheim Investigational Site - Chicago

Michigan

  • 1218.35.10015 Boehringer Ingelheim Investigational Site - Flint

North Carolina

  • 1218.35.10018 Boehringer Ingelheim Investigational Site - Asheville

Trial Details

FieldValue
Enrollment Target 245 participants
Start Date 2008-12
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00819091

The ClinicalTrials.gov registry entry for NCT00819091 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (95% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00819091 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00819091 about?

NCT00819091 is a clinical study titled "Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug". Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

What is the current status of trial NCT00819091?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2008-12.

What conditions does trial NCT00819091 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT00819091?

The interventions under investigation include: Placebo (DRUG), BI 1356 (DRUG).

Who is sponsoring clinical trial NCT00819091?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00819091 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.