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

NCT ID: NCT01422876

Last Updated: 2015-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 10773/linagliptin FDC (high dose)

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

Group Type EXPERIMENTAL

high dose FDC

Intervention Type DRUG

once daily

low dose FDC placebo

Intervention Type DRUG

once daily

high dose BI 10773 placebo

Intervention Type DRUG

once daily

BI 10773 low dose placebo

Intervention Type DRUG

once daily

linagliptin placebo

Intervention Type DRUG

once daily

BI 10773/linagliptin FDC (low dose)

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

Group Type EXPERIMENTAL

high dose FDC placebo

Intervention Type DRUG

once daily

low dose FDC

Intervention Type DRUG

once daily

high dose BI 10773 placebo

Intervention Type DRUG

once daily

BI 10773 low dose placebo

Intervention Type DRUG

once daily

linagliptin placebo

Intervention Type DRUG

once daily

BI 10773 (high dose)

Patients receive BI 10773 (high dose) once daily

Group Type ACTIVE_COMPARATOR

BI 10773 high dose

Intervention Type DRUG

once daily

high dose FDC placebo

Intervention Type DRUG

once daily

low dose FDC placebo

Intervention Type DRUG

once daily

low dose BI 10773 placebo

Intervention Type DRUG

once daily

linagliptin placebo

Intervention Type DRUG

once daily

BI 10773 (low dose)

Patients receive BI 10773 (low dose) once daily

Group Type ACTIVE_COMPARATOR

high dose FDC placebo

Intervention Type DRUG

once daily

low dose FDC placebo

Intervention Type DRUG

once daily

high dose BI 10773 placebo

Intervention Type DRUG

once daily

BI 10773 low dose

Intervention Type DRUG

low dose once daily

linagliptin placebo

Intervention Type DRUG

once daily

Linagliptin

Patients receive linagliptin once daily

Group Type ACTIVE_COMPARATOR

low dose FDC placebo

Intervention Type DRUG

once daily

high dose FDC placebo

Intervention Type DRUG

once daily

linagliptin

Intervention Type DRUG

once daily

high dose BI 10773 placebo

Intervention Type DRUG

once daily

low dose BI 10773 placebo

Intervention Type DRUG

once daily

Interventions

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high dose FDC

once daily

Intervention Type DRUG

BI 10773 high dose

once daily

Intervention Type DRUG

high dose FDC placebo

once daily

Intervention Type DRUG

low dose FDC placebo

once daily

Intervention Type DRUG

high dose FDC placebo

once daily

Intervention Type DRUG

high dose FDC placebo

once daily

Intervention Type DRUG

low dose FDC placebo

once daily

Intervention Type DRUG

low dose FDC placebo

once daily

Intervention Type DRUG

high dose BI 10773 placebo

once daily

Intervention Type DRUG

low dose FDC

once daily

Intervention Type DRUG

high dose FDC placebo

once daily

Intervention Type DRUG

BI 10773 low dose

low dose once daily

Intervention Type DRUG

high dose BI 10773 placebo

once daily

Intervention Type DRUG

high dose BI 10773 placebo

once daily

Intervention Type DRUG

linagliptin

once daily

Intervention Type DRUG

low dose FDC placebo

once daily

Intervention Type DRUG

linagliptin placebo

once daily

Intervention Type DRUG

BI 10773 low dose placebo

once daily

Intervention Type DRUG

linagliptin placebo

once daily

Intervention Type DRUG

low dose BI 10773 placebo

once daily

Intervention Type DRUG

linagliptin placebo

once daily

Intervention Type DRUG

high dose BI 10773 placebo

once daily

Intervention Type DRUG

BI 10773 low dose placebo

once daily

Intervention Type DRUG

low dose BI 10773 placebo

once daily

Intervention Type DRUG

linagliptin placebo

once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1275.1.01103 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1275.1.01107 Boehringer Ingelheim Investigational Site

Foley, Alabama, United States

Site Status

1275.1.01043 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1275.1.01066 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1275.1.01047 Boehringer Ingelheim Investigational Site

Pell City, Alabama, United States

Site Status

1275.1.01089 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Site Status

1275.1.01064 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Site Status

1275.1.01028 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

1275.1.01086 Boehringer Ingelheim Investigational Site

Cerritos, California, United States

Site Status

1275.1.01067 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Site Status

1275.1.01109 Boehringer Ingelheim Investigational Site

Encino, California, United States

Site Status

1275.1.01012 Boehringer Ingelheim Investigational Site

Fresno, California, United States

Site Status

1275.1.01050 Boehringer Ingelheim Investigational Site

Harbor City, California, United States

Site Status

1275.1.01056 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Site Status

1275.1.01021 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

1275.1.01024 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1275.1.01112 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1275.1.01083 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Site Status

1275.1.01071 Boehringer Ingelheim Investigational Site

San Dimas, California, United States

Site Status

1275.1.01044 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Site Status

1275.1.01078 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Site Status

1275.1.01124 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Site Status

1275.1.01010 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1275.1.01048 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1275.1.01073 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Site Status

1275.1.01063 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

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1275.1.01077 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

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1275.1.01090 Boehringer Ingelheim Investigational Site

Inverness, Florida, United States

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1275.1.01054 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

1275.1.01092 Boehringer Ingelheim Investigational Site

Maitland, Florida, United States

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1275.1.01065 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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1275.1.01110 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1275.1.01040 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Site Status

1275.1.01025 Boehringer Ingelheim Investigational Site

Miami Lakes, Florida, United States

Site Status

1275.1.01094 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

1275.1.01068 Boehringer Ingelheim Investigational Site

Ormond Beach, Florida, United States

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1275.1.01051 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

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1275.1.01079 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

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1275.1.01117 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

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1275.1.01039 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1275.1.01007 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

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1275.1.01111 Boehringer Ingelheim Investigational Site

Norcross, Georgia, United States

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1275.1.01076 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

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1275.1.01100 Boehringer Ingelheim Investigational Site

Addison, Illinois, United States

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1275.1.01042 Boehringer Ingelheim Investigational Site

Des Moines, Iowa, United States

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1275.1.01059 Boehringer Ingelheim Investigational Site

Paducah, Kentucky, United States

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1275.1.01003 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

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1275.1.01125 Boehringer Ingelheim Investigational Site

Hyattsville, Maryland, United States

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1275.1.01081 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

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1275.1.01085 Boehringer Ingelheim Investigational Site

Rochester, Michigan, United States

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1275.1.01035 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

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1275.1.01023 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

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1275.1.01027 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

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1275.1.01033 Boehringer Ingelheim Investigational Site

Great Falls, Montana, United States

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1275.1.01099 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

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1275.1.01101 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1275.1.01114 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1275.1.01123 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1275.1.01013 Boehringer Ingelheim Investigational Site

Elizabeth, New Jersey, United States

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1275.1.01057 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

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1275.1.01002 Boehringer Ingelheim Investigational Site

Binghamton, New York, United States

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1275.1.01020 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

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1275.1.01095 Boehringer Ingelheim Investigational Site

Flushing, New York, United States

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1275.1.01062 Boehringer Ingelheim Investigational Site

Glens Falls, New York, United States

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1275.1.01006 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1275.1.01011 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

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1275.1.01052 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

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1275.1.01045 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

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1275.1.01001 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

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1275.1.01032 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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1275.1.01061 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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1275.1.01116 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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1275.1.01016 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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1275.1.01102 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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1275.1.01017 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

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1275.1.01036 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

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1275.1.01030 Boehringer Ingelheim Investigational Site

Delaware, Ohio, United States

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1275.1.01055 Boehringer Ingelheim Investigational Site

Groveport, Ohio, United States

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1275.1.01075 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

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1275.1.01034 Boehringer Ingelheim Investigational Site

Norman, Oklahoma, United States

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1275.1.01082 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

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1275.1.01084 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

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1275.1.01038 Boehringer Ingelheim Investigational Site

Fleetwood, Pennsylvania, United States

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1275.1.01019 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

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1275.1.01072 Boehringer Ingelheim Investigational Site

Scottdale, Pennsylvania, United States

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1275.1.01088 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

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1275.1.01014 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

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1275.1.01060 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

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1275.1.01093 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

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1275.1.01122 Boehringer Ingelheim Investigational Site

Florence, South Carolina, United States

Site Status

1275.1.01005 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

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1275.1.01015 Boehringer Ingelheim Investigational Site

Brentwood, Tennessee, United States

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1275.1.01031 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

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1275.1.01121 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

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1275.1.01069 Boehringer Ingelheim Investigational Site

Spring Hill, Tennessee, United States

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1275.1.01049 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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1275.1.01080 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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1275.1.01029 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1275.1.01053 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1275.1.01106 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1275.1.01018 Boehringer Ingelheim Investigational Site

Pearland, Texas, United States

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1275.1.01096 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1275.1.01113 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1275.1.01120 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1275.1.01105 Boehringer Ingelheim Investigational Site

Spring, Texas, United States

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1275.1.01037 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

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1275.1.01008 Boehringer Ingelheim Investigational Site

Bountiful, Utah, United States

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1275.1.01022 Boehringer Ingelheim Investigational Site

West Jordan, Utah, United States

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1275.1.01091 Boehringer Ingelheim Investigational Site

South Chesterfield, Virginia, United States

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1275.1.01118 Boehringer Ingelheim Investigational Site

Selah, Washington, United States

Site Status

1275.1.01087 Boehringer Ingelheim Investigational Site

Shoreline, Washington, United States

Site Status

1275.1.01119 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1275.1.54001 Boehringer Ingelheim Investigational Site

Caba, , Argentina

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1275.1.54005 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1275.1.54003 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

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1275.1.54004 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

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1275.1.54002 Boehringer Ingelheim Investigational Site

Mendoza, , Argentina

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1275.1.61003 Boehringer Ingelheim Investigational Site

Wollongong, New South Wales, Australia

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1275.1.61002 Boehringer Ingelheim Investigational Site

East Ringwood, Victoria, Australia

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1275.1.55002 Boehringer Ingelheim Investigational Site

Joaquim Távora, , Brazil

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1275.1.55001 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, , Brazil

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1275.1.55005 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

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1275.1.59003 Boehringer Ingelheim Investigational Site

Plovdiv, , Bulgaria

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1275.1.59006 Boehringer Ingelheim Investigational Site

Rousse, , Bulgaria

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1275.1.59004 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1275.1.20008 Boehringer Ingelheim Investigational Site

Bathurst, New Brunswick, Canada

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1275.1.20007 Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

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1275.1.20006 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

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1275.1.20004 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

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1275.1.20001 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

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1275.1.20005 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1275.1.20003 Boehringer Ingelheim Investigational Site

Drummondville, Quebec, Canada

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1275.1.20002 Boehringer Ingelheim Investigational Site

Pointe-Claire, Quebec, Canada

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1275.1.57004 Boehringer Ingelheim Investigational Site

Barranquilla, , Colombia

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1275.1.57002 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

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1275.1.57005 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

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1275.1.57003 Boehringer Ingelheim Investigational Site

Tolima, , Colombia

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1275.1.45004 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

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1275.1.45003 Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

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1275.1.45002 Boehringer Ingelheim Investigational Site

København NV, , Denmark

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1275.1.37206 Boehringer Ingelheim Investigational Site

Kiviõli, , Estonia

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1275.1.37202 Boehringer Ingelheim Investigational Site

Pärnu, , Estonia

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1275.1.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1275.1.37204 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1275.1.37203 Boehringer Ingelheim Investigational Site

Viljandi County, , Estonia

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1275.1.36002 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1275.1.36003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1275.1.36001 Boehringer Ingelheim Investigational Site

Gyöngyös, , Hungary

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1275.1.39003 Boehringer Ingelheim Investigational Site

Bassano Del Grappa (VI), , Italy

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1275.1.39002 Boehringer Ingelheim Investigational Site

Fermo, , Italy

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1275.1.39001 Boehringer Ingelheim Investigational Site

Milan, , Italy

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1275.1.39004 Boehringer Ingelheim Investigational Site

Roma, , Italy

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1275.1.96004 Boehringer Ingelheim Investigational Site

Baabda, , Lebanon

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1275.1.96002 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

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1275.1.96003 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

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1275.1.96006 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

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1275.1.96008 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

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1275.1.96007 Boehringer Ingelheim Investigational Site

Saida, , Lebanon

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1275.1.60001 Boehringer Ingelheim Investigational Site

Kedah, , Malaysia

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1275.1.60002 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

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1275.1.52002 Boehringer Ingelheim Investigational Site

México, , Mexico

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1275.1.52005 Boehringer Ingelheim Investigational Site

México, , Mexico

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1275.1.52003 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

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1275.1.52001 Boehringer Ingelheim Investigational Site

Pachuca, , Mexico

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1275.1.52004 Boehringer Ingelheim Investigational Site

San Luis Potosí City, , Mexico

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1275.1.51001 Boehringer Ingelheim Investigational Site

Arequipa, , Peru

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1275.1.51003 Boehringer Ingelheim Investigational Site

Ica, , Peru

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1275.1.51002 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1275.1.51004 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1275.1.51005 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1275.1.63002 Boehringer Ingelheim Investigational Site

Davao City, , Philippines

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1275.1.63001 Boehringer Ingelheim Investigational Site

Greenhills, San Juan, , Philippines

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1275.1.63004 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1275.1.63006 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

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1275.1.63003 Boehringer Ingelheim Investigational Site

Pasay, , Philippines

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1275.1.63005 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

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1275.1.48002 Boehringer Ingelheim Investigational Site

Lodz, , Poland

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1275.1.48004 Boehringer Ingelheim Investigational Site

Poznan, , Poland

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1275.1.48001 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

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1275.1.48003 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

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1275.1.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, , Romania

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1275.1.40005 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, , Romania

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1275.1.40004 Boehringer Ingelheim Investigational Site

Brasov, , Romania

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1275.1.40008 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1275.1.40009 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1275.1.40006 Boehringer Ingelheim Investigational Site

Cluj-Napoca, , Romania

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1275.1.40007 Boehringer Ingelheim Investigational Site

Galati, , Romania

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1275.1.40002 Boehringer Ingelheim Investigational Site

Oradea, , Romania

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1275.1.40010 Boehringer Ingelheim Investigational Site

Sibiu, , Romania

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1275.1.40003 Boehringer Ingelheim Investigational Site

Târgu Mureş, , Romania

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1275.1.70006 Boehringer Ingelheim Investigational Site

Arkhangelsk, , Russia

Site Status

1275.1.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1275.1.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1275.1.70003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1275.1.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1275.1.70004 Boehringer Ingelheim Investigational Site

Samara, , Russia

Site Status

1275.1.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1275.1.34005 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1275.1.34002 Boehringer Ingelheim Investigational Site

Hospitalet de Llobegrat, , Spain

Site Status

1275.1.34003 Boehringer Ingelheim Investigational Site

Palma de Mallorca, , Spain

Site Status

1275.1.34006 Boehringer Ingelheim Investigational Site

Tarragona, , Spain

Site Status

1275.1.46003 Boehringer Ingelheim Investigational Site

Järfälla, , Sweden

Site Status

1275.1.46004 Boehringer Ingelheim Investigational Site

Rättvik, , Sweden

Site Status

1275.1.46002 Boehringer Ingelheim Investigational Site

Skene, , Sweden

Site Status

1275.1.88006 Chang Gung Memorial Hospital-CY

Chiayi City, , Taiwan

Site Status

1275.1.88007 E-Da Hospital

Kaohsiung City, , Taiwan

Site Status

1275.1.88001 Cardinal Tien Hospital

New Taipei City, , Taiwan

Site Status

1275.1.88004 Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

1275.1.88008 Chi Mei Medical Center

Tainan City, , Taiwan

Site Status

1275.1.88002 Far Eastern Memorial Hospital

Taipei, , Taiwan

Site Status

1275.1.88003 Taipei Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Argentina Australia Brazil Bulgaria Canada Colombia Denmark Estonia Hungary Italy Lebanon Malaysia Mexico Peru Philippines Poland Romania Russia Spain Sweden Taiwan

References

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DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15.

Reference Type DERIVED
PMID: 29949041 (View on PubMed)

Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29.

Reference Type DERIVED
PMID: 25633662 (View on PubMed)

DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12.

Reference Type DERIVED
PMID: 25583754 (View on PubMed)

Other Identifiers

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2011-000383-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1275.1

Identifier Type: -

Identifier Source: org_study_id

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