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NCT00749190 · ClinicalTrials.gov registry record · Phase 2

BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
495
Enrollment target

NCT00749190: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT00749190 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 495 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (272% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00749190, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
495 participants
Enrollment target

Study Summary

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Primary Outcome

Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Interventions

  • DRUG placebo
  • DRUG sitagliptin
  • DRUG BI 10773

Trial Details

FieldValue
Enrollment Target 495 participants
Start Date 2008-08
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT00749190 record still lists

NCT00749190 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (272% higher).

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

NCT00749190 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00749190 about?

NCT00749190 is a clinical study titled "BI 10773 add-on to Metformin in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open...

What is the current status of trial NCT00749190?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 495 participants. The study started on 2008-08.

What interventions are being tested in trial NCT00749190?

The interventions under investigation include: placebo (DRUG), sitagliptin (DRUG), BI 10773 (DRUG).

Who is sponsoring clinical trial NCT00749190?

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

How this trial's enrollment target compares

Where NCT00749190's enrollment target sits among peer trials

495 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00749190, the US trial registry maintained by the National Library of Medicine. NCT00749190 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.