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

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Renal Insufficiency
Interventions
Drug: Placebo
Registration Number
NCT01164501
Lead Sponsor
Boehringer Ingelheim
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
741
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BI 10773 low doseBI 10773BI 10773 tablets once daily
BI 10773 low dosePlaceboBI 10773 tablets once daily
BI 10773 high dosePlaceboBI 10773 tablets once daily
BI 10773 high doseBI 10773BI 10773 tablets once daily
PlaceboPlaceboPlacebo tablets matching BI 10773
Primary Outcome Measures
NameTimeMethod
HbA1c Change From Baseline in Patients With Mild or Moderate Renal ImpairmentBaseline and 24 weeks

Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.

Note adjusted means are provided.

HbA1c Change From Baseline in Patients With Mild Renal ImpairmentBaseline and 24 weeks

Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.

Note adjusted means are provided.

HbA1c Change From Baseline in Patients With Moderate Renal ImpairmentBaseline and 24 weeks

Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.

Note adjusted means are provided.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (127)

1245.36.10014 Boehringer Ingelheim Investigational Site

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Anaheim, California, United States

1245.36.10019 Boehringer Ingelheim Investigational Site

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Lomita, California, United States

1245.36.10017 Boehringer Ingelheim Investigational Site

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Plantation, Florida, United States

1245.36.10009 Boehringer Ingelheim Investigational Site

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West Palm Beach, Florida, United States

1245.36.10018 Boehringer Ingelheim Investigational Site

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Honolulu, Hawaii, United States

1245.36.10015 Boehringer Ingelheim Investigational Site

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Shreveport, Louisiana, United States

1245.36.10021 Boehringer Ingelheim Investigational Site

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Endwell, New York, United States

1245.36.10008 Boehringer Ingelheim Investigational Site

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Greenville, North Carolina, United States

1245.36.10005 Boehringer Ingelheim Investigational Site

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Bethlehem, Pennsylvania, United States

1245.36.10003 Boehringer Ingelheim Investigational Site

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Melrose Park, Pennsylvania, United States

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1245.36.10014 Boehringer Ingelheim Investigational Site
🇺🇸Anaheim, California, United States

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