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: BI 10773; 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

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-16
• Last Update Posted: 2014-06-16

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

Group	Intervention	Description
BI 10773 low dose	BI 10773	BI 10773 tablets once daily
BI 10773 low dose	Placebo	BI 10773 tablets once daily
BI 10773 high dose	Placebo	BI 10773 tablets once daily
BI 10773 high dose	BI 10773	BI 10773 tablets once daily
Placebo	Placebo	Placebo tablets matching BI 10773

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment	Baseline 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 Impairment	Baseline 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 Impairment	Baseline and 24 weeks	Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.; Note adjusted means are provided.

Trial Locations

Locations (127)

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

1245.36.10019 Boehringer Ingelheim Investigational Site; 🇺🇸 Lomita, California, United States

1245.36.10017 Boehringer Ingelheim Investigational Site; 🇺🇸 Plantation, Florida, United States

1245.36.10009 Boehringer Ingelheim Investigational Site; 🇺🇸 West Palm Beach, Florida, United States

1245.36.10018 Boehringer Ingelheim Investigational Site; 🇺🇸 Honolulu, Hawaii, United States

1245.36.10015 Boehringer Ingelheim Investigational Site; 🇺🇸 Shreveport, Louisiana, United States

1245.36.10021 Boehringer Ingelheim Investigational Site; 🇺🇸 Endwell, New York, United States

1245.36.10008 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, North Carolina, United States

1245.36.10005 Boehringer Ingelheim Investigational Site; 🇺🇸 Bethlehem, Pennsylvania, United States

1245.36.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Melrose Park, Pennsylvania, United States

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