A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: empagliflozin (low dose qd); Drug: Placebo; Drug: empagliflozin (low dose bid); Drug: Empagliflozin (high dose qd); Drug: empagliflozin (high dose bid)

• Registration Number: NCT01649297
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-25
• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Disposition First Submitted: 2014-03-27
• Disposition First Submitted QC: 2014-03-27
• Disposition First Posted: 2014-04-24
• Status Verified: 2015-06
• Results First Submitted: 2015-06-26
• Results First Submitted QC: 2015-06-26
• Last Update Submitted: 2015-06-26
• Results First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 983

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
empagliflozin (low dose qd)	empagliflozin (low dose qd)	Patients receive Empagliflozin low dose once daily
empagliflozin (low dose bid)	Placebo	Patients receive Empagliflozin low dose split twice daily
Placebo	Placebo	Patients receive placebo matching Empagliflozin
empagliflozin (low dose qd)	Placebo	Patients receive Empagliflozin low dose once daily
empagliflozin (low dose bid)	empagliflozin (low dose bid)	Patients receive Empagliflozin low dose split twice daily
empagliflozin (high dose qd)	Placebo	Patients receive Empagliflozin high dose once daily
empagliflozin (high dose qd)	Empagliflozin (high dose qd)	Patients receive Empagliflozin high dose once daily
empagliflozin (high dose bid)	empagliflozin (high dose bid)	Patients receive Empagliflozin high dose split twice daily
empagliflozin (high dose bid)	Placebo	Patients receive Empagliflozin high dose split twice daily

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16	Baseline and 16 weeks	Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.; Means provided are the adjusted means.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16	Baseline and 16 weeks	Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.; Means provided are the adjusted means.

Trial Locations

Locations (139)

1276.10.11036 Boehringer Ingelheim Investigational Site; 🇺🇸 Florence, Alabama, United States

1276.10.11049 Boehringer Ingelheim Investigational Site; 🇺🇸 Jonesboro, Arkansas, United States

1276.10.11040 Boehringer Ingelheim Investigational Site; 🇺🇸 Lomita, California, United States

1276.10.11033 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1276.10.11002 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Cucamonga, California, United States

1276.10.11050 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacramento, California, United States

1276.10.11015 Boehringer Ingelheim Investigational Site; 🇺🇸 West Hills, California, United States

1276.10.11012 Boehringer Ingelheim Investigational Site; 🇺🇸 Norwalk, Connecticut, United States

1276.10.11047 Boehringer Ingelheim Investigational Site; 🇺🇸 Waterbury, Connecticut, United States

1276.10.11010 Boehringer Ingelheim Investigational Site; 🇺🇸 Bradenton, Florida, United States

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