Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

Key facts

Study ID

NCT01422876

Run by

Boehringer Ingelheim

People needed

1405

Starts

2011-08-01

Expected to finish

2013-09-01

Last updated by the study team

2015-04-02

Who can join

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

You may qualify if…

• Diagnosis of type 2 diabetes mellitus prior to informed consent
• Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
• Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

You may not qualify if…

• Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
• Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
• Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent

Where it is running

• 1275.1.01107 Boehringer Ingelheim Investigational Site — Foley, Alabama, United States
• 1275.1.01043 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1275.1.01066 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1275.1.01047 Boehringer Ingelheim Investigational Site — Pell City, Alabama, United States
• 1275.1.01089 Boehringer Ingelheim Investigational Site — Mesa, Arizona, United States
• 1275.1.01064 Boehringer Ingelheim Investigational Site — Tempe, Arizona, United States
• 1275.1.01028 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1275.1.01086 Boehringer Ingelheim Investigational Site — Cerritos, California, United States
• 1275.1.01067 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States
• 1275.1.01109 Boehringer Ingelheim Investigational Site — Encino, California, United States
• 1275.1.01012 Boehringer Ingelheim Investigational Site — Fresno, California, United States
• 1275.1.01050 Boehringer Ingelheim Investigational Site — Harbor City, California, United States
• 1275.1.01056 Boehringer Ingelheim Investigational Site — Huntington Park, California, United States
• 1275.1.01021 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• 1275.1.01024 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1275.1.01112 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1275.1.01083 Boehringer Ingelheim Investigational Site — Oceanside, California, United States
• 1275.1.01071 Boehringer Ingelheim Investigational Site — San Dimas, California, United States
• 1275.1.01044 Boehringer Ingelheim Investigational Site — Tustin, California, United States
• 1275.1.01078 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
• 1275.1.01124 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
• 1275.1.01010 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1275.1.01048 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1275.1.01073 Boehringer Ingelheim Investigational Site — Gainesville, Florida, United States
• 1275.1.01103 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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