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NCT00622284 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
1,560
Enrollment target

NCT00622284 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,560 participants.

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The verdict

NCT00622284, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
1,560 participants
Enrollment target

Study Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Interventions

  • DRUG Glimepiride
  • DRUG BI 1356
  • DRUG Placebo identical to BI 1356 5mg
  • DRUG Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg

Trial Details

FieldValue
Enrollment Target 1,560 participants
Start Date 2008-02
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00622284

The ClinicalTrials.gov registry entry for NCT00622284 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,560 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 4 interventions - of which Glimepiride is the first listed.

NCT00622284 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00622284 about?

NCT00622284 is a clinical study titled "Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

What is the current status of trial NCT00622284?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,560 participants. The study started on 2008-02.

What interventions are being tested in trial NCT00622284?

The interventions under investigation include: Glimepiride (DRUG), BI 1356 (DRUG), Placebo identical to BI 1356 5mg (DRUG), Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg (DRUG).

Who is sponsoring clinical trial NCT00622284?

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.