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Completed Phase 3 Interventional Results available

Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

ClinicalTrials.gov ID: NCT01164501

Public ClinicalTrials.gov record NCT01164501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 10:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01164501
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
741 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2010 (Type not available)
Primary completion
Jul 2012 (Actual)
Completion
Jul 2012 (Actual)
Last update posted
Jun 16, 2014

2010 – 2012

United States locations

U.S. sites
18
U.S. states
10
U.S. cities
18
Facility City State ZIP Site status
1245.36.10014 Boehringer Ingelheim Investigational Site Anaheim California — —
1245.36.10019 Boehringer Ingelheim Investigational Site Lomita California — —
1245.36.10017 Boehringer Ingelheim Investigational Site Plantation Florida — —
1245.36.10009 Boehringer Ingelheim Investigational Site West Palm Beach Florida — —
1245.36.10018 Boehringer Ingelheim Investigational Site Honolulu Hawaii — —
1245.36.10015 Boehringer Ingelheim Investigational Site Shreveport Louisiana — —
1245.36.10021 Boehringer Ingelheim Investigational Site Endwell New York — —
1245.36.10008 Boehringer Ingelheim Investigational Site Greenville North Carolina — —
1245.36.10005 Boehringer Ingelheim Investigational Site Bethlehem Pennsylvania — —
1245.36.10003 Boehringer Ingelheim Investigational Site Melrose Park Pennsylvania — —
1245.36.10004 Boehringer Ingelheim Investigational Site Greer South Carolina — —
1245.36.10012 Boehringer Ingelheim Investigational Site Corpus Christi Texas — —
1245.36.10013 Boehringer Ingelheim Investigational Site Dallas Texas — —
1245.36.10002 Boehringer Ingelheim Investigational Site Houston Texas — —
1245.36.10007 Boehringer Ingelheim Investigational Site San Antonio Texas — —
1245.36.10023 Boehringer Ingelheim Investigational Site Renton Washington — —
1245.36.10011 Boehringer Ingelheim Investigational Site Spokane Washington — —
1245.36.10006 Boehringer Ingelheim Investigational Site Tacoma Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 109 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01164501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 16, 2014 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01164501 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →