Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01164501 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 741
- Enrollment target
NCT01164501: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01164501 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 741 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164501, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 741 participants
- Enrollment target
Study Summary
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
Primary Outcome
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.
Interventions
- DRUG Placebo
- DRUG BI 10773
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 741 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01164501 record still lists
NCT01164501 is an interventional study that assigns participants to a tested intervention. The registered 741 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01164501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01164501 about?
NCT01164501 is a clinical study titled "Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment". This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
What is the current status of trial NCT01164501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 741 participants. The study started on 2010-07. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01164501?
The interventions under investigation include: Placebo (DRUG), BI 10773 (DRUG).
Who is sponsoring clinical trial NCT01164501?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01164501's enrollment target sits among peer trials
741 476th of 2000 higher than 1,524 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05786417 · 741 participants · Phase 4
LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
- NCT06556563 · 741 participants · Phase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
- NCT03963622 · 740 participants · NA
Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
- NCT04074135 · 740 participants · Phase 2
Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia