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NCT01011868 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
494
Enrollment target

NCT01011868: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT01011868 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 494 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (271% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01011868, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
494 participants
Enrollment target

Study Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Primary Outcome

Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment

Interventions

  • DRUG BI 10773 placebo
  • DRUG BI 10773 low dose
  • DRUG BI 10773 high dose

Trial Details

FieldValue
Enrollment Target 494 participants
Start Date 2009-11
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT01011868 record still lists

NCT01011868 is an interventional study that assigns participants to a tested intervention. The registered 494 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 (271% higher).

The record links to 0 conditions, and to 3 interventions - of which BI 10773 placebo is the first listed.

NCT01011868 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01011868 about?

NCT01011868 is a clinical study titled "Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

What is the current status of trial NCT01011868?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 494 participants. The study started on 2009-11.

What interventions are being tested in trial NCT01011868?

The interventions under investigation include: BI 10773 placebo (DRUG), BI 10773 low dose (DRUG), BI 10773 high dose (DRUG).

Who is sponsoring clinical trial NCT01011868?

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 NCT01011868's enrollment target sits among peer trials

494 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 NCT01011868, the US trial registry maintained by the National Library of Medicine. NCT01011868 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.