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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01649297

Run by

Boehringer Ingelheim

People needed

983

Starts

2012-10-01

Expected to finish

2013-12-01

Last updated by the study team

2015-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• confirmed diagnosis of T2DM
• Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
• Metformin therapy (at least 1500 mg/day, BID)
• age>=18 at Visit 1
• body mass index <=45 kg/m2

You may not qualify if…

• estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
• a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

Where it is running

• 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
• 1276.10.11005 Boehringer Ingelheim Investigational Site — Davie, Florida, United States
• 1276.10.11004 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 1276.10.11051 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1276.10.11009 Boehringer Ingelheim Investigational Site — Oakland Park, Florida, United States
• 1276.10.11044 Boehringer Ingelheim Investigational Site — Palm Harbor, Florida, United States
• 1276.10.11030 Boehringer Ingelheim Investigational Site — Dunwoody, Georgia, United States
• 1276.10.11027 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1276.10.11020 Boehringer Ingelheim Investigational Site — Elwood, Indiana, United States
• 1276.10.11001 Boehringer Ingelheim Investigational Site — Bangor, Maine, United States
• 1276.10.11048 Boehringer Ingelheim Investigational Site — Sterling Heights, Michigan, United States
• 1276.10.11058 Boehringer Ingelheim Investigational Site — Jackson, Mississippi, United States
• 1276.10.11055 Boehringer Ingelheim Investigational Site — Edison, New Jersey, United States
• 1276.10.11011 Boehringer Ingelheim Investigational Site — Brooklyn, New York, United States
• 1276.10.11035 Boehringer Ingelheim Investigational Site — North Myrtle Beach, North Carolina, United States
• 1276.10.11041 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1276.10.11036 Boehringer Ingelheim Investigational Site — Florence, Alabama, United States

Full record on ClinicalTrials.gov

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