Status:
COMPLETED
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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)
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1405 Patients enrolled
Trial Details
Trial ID
NCT01422876
Start Date
August 1 2011
End Date
September 1 2013
Last Update
April 2 2015
Active Locations (211)
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1
1275.1.01103 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
1275.1.01107 Boehringer Ingelheim Investigational Site
Foley, Alabama, United States
3
1275.1.01043 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
4
1275.1.01066 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States