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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773 low dose placebo; Drug: high dose FDC placebo; Drug: high dose BI 10773 placebo; Drug: linagliptin placebo; Drug: low dose FDC; Drug: BI 10773 high dose; Drug: low dose FDC placebo; Drug: high dose FDC; Drug: linagliptin; Drug: BI 10773 low dose; Drug: low dose BI 10773 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01422876

1275.1

2011-000383-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,405 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. 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.
3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Exclusion criteria

1. 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).
2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,405 participants in 5 patient groups

BI 10773/linagliptin FDC (high dose)

Experimental group

Description:

Patients receive BI 10773/linagliptin FDC (high dose) once daily

Treatment:

Drug: low dose FDC placebo

Drug: low dose FDC placebo

Drug: linagliptin placebo

Drug: low dose FDC placebo

Drug: linagliptin placebo

Drug: linagliptin placebo

Drug: low dose FDC placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: BI 10773 low dose placebo

Drug: BI 10773 low dose placebo

Drug: high dose FDC

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: linagliptin placebo

BI 10773/linagliptin FDC (low dose)

Experimental group

Description:

Patients receive BI 10773/linagliptin FDC (low dose) once daily

Treatment:

Drug: high dose FDC placebo

Drug: linagliptin placebo

Drug: high dose FDC placebo

Drug: linagliptin placebo

Drug: linagliptin placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: BI 10773 low dose placebo

Drug: high dose FDC placebo

Drug: BI 10773 low dose placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: low dose FDC

Drug: linagliptin placebo

Drug: high dose FDC placebo

BI 10773 (high dose)

Active Comparator group

Description:

Patients receive BI 10773 (high dose) once daily

Treatment:

Drug: low dose FDC placebo

Drug: high dose FDC placebo

Drug: low dose FDC placebo

Drug: linagliptin placebo

Drug: low dose FDC placebo

Drug: high dose FDC placebo

Drug: linagliptin placebo

Drug: linagliptin placebo

Drug: low dose FDC placebo

Drug: BI 10773 high dose

Drug: high dose FDC placebo

Drug: low dose BI 10773 placebo

Drug: linagliptin placebo

Drug: high dose FDC placebo

Drug: low dose BI 10773 placebo

BI 10773 (low dose)

Active Comparator group

Description:

Patients receive BI 10773 (low dose) once daily

Treatment:

Drug: low dose FDC placebo

Drug: high dose FDC placebo

Drug: low dose FDC placebo

Drug: linagliptin placebo

Drug: low dose FDC placebo

Drug: high dose FDC placebo

Drug: linagliptin placebo

Drug: BI 10773 low dose

Drug: linagliptin placebo

Drug: low dose FDC placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: high dose FDC placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: linagliptin placebo

Drug: high dose FDC placebo

Linagliptin

Active Comparator group

Description:

Patients receive linagliptin once daily

Treatment:

Drug: low dose FDC placebo

Drug: high dose FDC placebo

Drug: low dose FDC placebo

Drug: low dose FDC placebo

Drug: high dose FDC placebo

Drug: low dose FDC placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: high dose FDC placebo

Drug: high dose BI 10773 placebo

Drug: high dose BI 10773 placebo

Drug: low dose BI 10773 placebo

Drug: high dose FDC placebo

Drug: low dose BI 10773 placebo

Drug: linagliptin