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

Phase 3

Completed

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

• Registration Number: NCT01167881
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Study Start: 2010-08
• Primary Completion: 2013-08
• Results First Submitted: 2014-07-17
• Results First Submitted QC: 2014-07-17
• Results First Posted: 2014-08-08
• Study Completion: 2015-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1549

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glimepiride 1-4 mg plus metformin	Glimepiride	Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
BI 10773 dose plus metformin	Placebo	Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
BI 10773 dose plus metformin	BI 10773	Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
Glimepiride 1-4 mg plus metformin	Placebo	Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.

Primary Outcome Measures

Name	Time	Method
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.	Baseline and 104 weeks

Secondary Outcome Measures

Name	Time	Method
The Change From Baseline in HbA1c After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Body Weight From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.	baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Change in Body Weight From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks

Trial Locations

Locations (182)

1245.28.10005 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.28.10012 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.28.10016 Boehringer Ingelheim Investigational Site; 🇺🇸 Hot Springs, Arkansas, United States

1245.28.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacramento, California, United States

1245.28.10021 Boehringer Ingelheim Investigational Site; 🇺🇸 West Hills, California, United States

1245.28.10009 Boehringer Ingelheim Investigational Site; 🇺🇸 Bradednton, Florida, United States

1245.28.10015 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

1245.28.10033 Boehringer Ingelheim Investigational Site; 🇺🇸 Blue Ridge, Georgia, United States

1245.28.10026 Boehringer Ingelheim Investigational Site; 🇺🇸 Boise, Idaho, United States

1245.28.10007 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

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