Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773; Drug: Placebo identical to BI 10773 high dose; Drug: Placebo identical to BI 10773 low dose

• Registration Number: NCT01159600
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Primary Completion: 2012-02
• 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: 1504

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo identical to BI 10773 high dose	Placebo matching BI 10773
BI 10773 open-label	BI 10773	BI 10773 once daily high dose open label
BI 10773 Arm 2	BI 10773	BI 10773 once daily high dose
BI 10773 Arm 2	Placebo identical to BI 10773 low dose	BI 10773 once daily high dose
Placebo	Placebo identical to BI 10773 low dose	Placebo matching BI 10773
BI 10773 Arm 1	Placebo identical to BI 10773 high dose	BI 10773 once daily low dose
BI 10773 Arm 1	BI 10773	BI 10773 once daily low dose

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline	Baseline and 24 weeks	Change from baseline in HbA1c after 24 weeks.; For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Secondary Outcome Measures

Name	Time	Method
Body Weight Change From Baseline	Baseline and 24 weeks	Body weight change from baseline after 24 weeks.; For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Mean Daily Plasma Glucose (MDG) Change From Baseline	Baseline and 24 weeks	Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.; For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

Trial Locations

Locations (148)

1245.23.10145 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1245.23.10046 Boehringer Ingelheim Investigational Site; 🇺🇸 Tempe, Arizona, United States

1245.23.10095 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Park, California, United States

1245.23.10109 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Park, California, United States

1245.23.10074 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1245.23.10149 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Cucamonga, California, United States

1245.23.10127 Boehringer Ingelheim Investigational Site; 🇺🇸 Waterbury, Connecticut, United States

1245.23.10042 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Lauderdale, Florida, United States

1245.23.10133 Boehringer Ingelheim Investigational Site; 🇺🇸 Jupiter, Florida, United States

1245.23.10080 Boehringer Ingelheim Investigational Site; 🇺🇸 Decatur, Georgia, United States

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