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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
983
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive Empagliflozin low dose once daily
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive Empagliflozin high dose once daily
Patients receive Empagliflozin high dose split twice daily
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive Empagliflozin low dose split twice daily
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
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
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.
Time frame: Baseline and 16 weeks
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
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.
Time frame: Baseline and 16 weeks
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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
...and 129 more locations