Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Recruiting in Palo Alto (17 mi)
+210 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Boehringer Ingelheim
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
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)
Treatment Details
Interventions
- BI 10773 (Antidiabetic Agent)
- Linagliptin (Antidiabetic Agent)
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: BI 10773/linagliptin FDC (low dose)Experimental Treatment5 Interventions
Patients receive BI 10773/linagliptin FDC (low dose) once daily
Group II: BI 10773/linagliptin FDC (high dose)Experimental Treatment5 Interventions
Patients receive BI 10773/linagliptin FDC (high dose) once daily
Group III: BI 10773 (low dose)Active Control5 Interventions
Patients receive BI 10773 (low dose) once daily
Group IV: LinagliptinActive Control5 Interventions
Patients receive linagliptin once daily
Group V: BI 10773 (high dose)Active Control5 Interventions
Patients receive BI 10773 (high dose) once daily
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
1275.1.01024 Boehringer Ingelheim Investigational SiteLos Angeles, CA
1275.1.01092 Boehringer Ingelheim Investigational SiteMaitland, FL
1275.1.01079 Boehringer Ingelheim Investigational SitePort Orange, FL
1275.1.01039 Boehringer Ingelheim Investigational SiteAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Boehringer IngelheimLead Sponsor
Eli Lilly and CompanyIndustry Sponsor