Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773; Drug: Placebo

• Registration Number: NCT01210001
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Primary Completion: 2012-04
• 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: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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 for Pio and Met Background Medication Patients	Baseline and 24 weeks	Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.; Note that adjusted means are provided.
HbA1c Change From Baseline	Baseline and 24 weeks	Change From Baseline in HbA1c after 24 weeks.; Note that adjusted means are provided.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Change From Baseline	Baseline and 24 weeks	Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.; Note that adjusted means are provided.
Body Weight Change From Baseline	Baseline and 24 weeks	Change from baseline in body weight after 24 weeks.; Note that adjusted means are provided.

Trial Locations

Locations (68)

1245.19.10056 Boehringer Ingelheim Investigational Site; 🇺🇸 Muscle Shoals, Alabama, United States

1245.19.10162 Boehringer Ingelheim Investigational Site; 🇺🇸 Glendale, Arizona, United States

1245.19.10161 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.19.10046 Boehringer Ingelheim Investigational Site; 🇺🇸 Tempe, Arizona, United States

1245.19.10070 Boehringer Ingelheim Investigational Site; 🇺🇸 Irvine, California, United States

1245.19.10047 Boehringer Ingelheim Investigational Site; 🇺🇸 La Mesa, California, United States

1245.19.10149 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Cucamonga, California, United States

1245.19.10163 Boehringer Ingelheim Investigational Site; 🇺🇸 Riverside, California, United States

1245.19.10131 Boehringer Ingelheim Investigational Site; 🇺🇸 West Hills, California, United States

1245.19.10141 Boehringer Ingelheim Investigational Site; 🇺🇸 Milford, Connecticut, United States

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