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

NCT01422876 | Completed Phase 3 Results

• 2 other identifiers: 1275.12011-000383-10
• Study Type: interventional
• Target: 1,405
• Locations: 21 countries
• Sites: 206

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 regulatory authorities.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients

  Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

  Baseline and 24 weeks

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients

  Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

  Baseline and 24 weeks

Secondary Outcomes (6)

• Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients

  Baseline and 24 Weeks

• Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients

  Baseline and 24 Weeks

• Change From Baseline in Body Weight for Metformin Background Patients

  Baseline and 24 Weeks

• Change From Baseline in Body Weight for Treatment Naive Patients

  Baseline and 24 Weeks

• Occurrence of Treat to Target Efficacy Response for Metformin Background Patients

  24 Weeks

Study Arms (5)

BI 10773/linagliptin FDC (high dose)

EXPERIMENTAL

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

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

BI 10773/linagliptin FDC (low dose)

EXPERIMENTAL

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

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

BI 10773 (high dose)

ACTIVE COMPARATOR

Patients receive BI 10773 (high dose) once daily

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

BI 10773 (low dose)

ACTIVE COMPARATOR

Patients receive BI 10773 (low dose) once daily

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

Linagliptin

ACTIVE COMPARATOR

Patients receive linagliptin once daily

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

Interventions

high dose FDC DRUG

once daily

BI 10773/linagliptin FDC (high dose)

BI 10773 high dose DRUG

once daily

BI 10773 (high dose)

high dose FDC placebo DRUG

once daily

BI 10773 (low dose)

low dose FDC placebo DRUG

once daily

BI 10773/linagliptin FDC (high dose)

high dose BI 10773 placebo DRUG

once daily

BI 10773 (low dose)

low dose FDC DRUG

once daily

BI 10773/linagliptin FDC (low dose)

BI 10773 low dose DRUG

low dose once daily

BI 10773 (low dose)

linagliptin DRUG

once daily

Linagliptin

linagliptin placebo DRUG

once daily

BI 10773 (low dose)

BI 10773 low dose placebo DRUG

once daily

BI 10773/linagliptin FDC (high dose)

low dose BI 10773 placebo DRUG

once daily

BI 10773 (high dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (211)

1275.1.01103 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1275.1.01107 Boehringer Ingelheim Investigational Site

Foley, Alabama, United States

Location

1275.1.01043 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1275.1.01066 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1275.1.01047 Boehringer Ingelheim Investigational Site

Pell City, Alabama, United States

Location

1275.1.01089 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Location

1275.1.01064 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Location

1275.1.01028 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

1275.1.01086 Boehringer Ingelheim Investigational Site

Cerritos, California, United States

Location

1275.1.01067 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1275.1.01109 Boehringer Ingelheim Investigational Site

Encino, California, United States

Location

1275.1.01012 Boehringer Ingelheim Investigational Site

Fresno, California, United States

Location

1275.1.01050 Boehringer Ingelheim Investigational Site

Harbor City, California, United States

Location

1275.1.01056 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Location

1275.1.01021 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1275.1.01024 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1275.1.01112 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1275.1.01083 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Location

1275.1.01071 Boehringer Ingelheim Investigational Site

San Dimas, California, United States

Location

1275.1.01044 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Location

1275.1.01078 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

1275.1.01124 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

1275.1.01010 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1275.1.01048 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1275.1.01073 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Location

1275.1.01063 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1275.1.01077 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1275.1.01090 Boehringer Ingelheim Investigational Site

Inverness, Florida, United States

Location

1275.1.01054 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1275.1.01092 Boehringer Ingelheim Investigational Site

Maitland, Florida, United States

Location

1275.1.01065 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1275.1.01110 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1275.1.01040 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Location

1275.1.01025 Boehringer Ingelheim Investigational Site

Miami Lakes, Florida, United States

Location

1275.1.01094 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1275.1.01068 Boehringer Ingelheim Investigational Site

Ormond Beach, Florida, United States

Location

1275.1.01051 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1275.1.01079 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1275.1.01117 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

1275.1.01039 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1275.1.01007 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

1275.1.01111 Boehringer Ingelheim Investigational Site

Norcross, Georgia, United States

Location

1275.1.01076 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

1275.1.01100 Boehringer Ingelheim Investigational Site

Addison, Illinois, United States

Location

1275.1.01042 Boehringer Ingelheim Investigational Site

Des Moines, Iowa, United States

Location

1275.1.01059 Boehringer Ingelheim Investigational Site

Paducah, Kentucky, United States

Location

1275.1.01003 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

1275.1.01125 Boehringer Ingelheim Investigational Site

Hyattsville, Maryland, United States

Location

1275.1.01081 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1275.1.01085 Boehringer Ingelheim Investigational Site

Rochester, Michigan, United States

Location

1275.1.01035 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

Location

1275.1.01023 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1275.1.01027 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1275.1.01033 Boehringer Ingelheim Investigational Site

Great Falls, Montana, United States

Location

1275.1.01099 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

Location

1275.1.01101 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1275.1.01114 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1275.1.01123 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1275.1.01013 Boehringer Ingelheim Investigational Site

Elizabeth, New Jersey, United States

Location

1275.1.01057 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1275.1.01002 Boehringer Ingelheim Investigational Site

Binghamton, New York, United States

Location

1275.1.01020 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

1275.1.01095 Boehringer Ingelheim Investigational Site

Flushing, New York, United States

Location

1275.1.01062 Boehringer Ingelheim Investigational Site

Glens Falls, New York, United States

Location

1275.1.01006 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1275.1.01011 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Location

1275.1.01052 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

1275.1.01045 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1275.1.01001 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Location

1275.1.01032 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1275.1.01061 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1275.1.01116 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1275.1.01016 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1275.1.01102 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1275.1.01017 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1275.1.01036 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1275.1.01030 Boehringer Ingelheim Investigational Site

Delaware, Ohio, United States

Location

1275.1.01055 Boehringer Ingelheim Investigational Site

Groveport, Ohio, United States

Location

1275.1.01075 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

Location

1275.1.01034 Boehringer Ingelheim Investigational Site

Norman, Oklahoma, United States

Location

1275.1.01082 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Location

1275.1.01084 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Location

1275.1.01038 Boehringer Ingelheim Investigational Site

Fleetwood, Pennsylvania, United States

Location

1275.1.01019 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1275.1.01072 Boehringer Ingelheim Investigational Site

Scottdale, Pennsylvania, United States

Location

1275.1.01088 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

Location

1275.1.01014 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1275.1.01060 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1275.1.01093 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1275.1.01122 Boehringer Ingelheim Investigational Site

Florence, South Carolina, United States

Location

1275.1.01005 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

Location

1275.1.01015 Boehringer Ingelheim Investigational Site

Brentwood, Tennessee, United States

Location

1275.1.01031 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Location

1275.1.01121 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1275.1.01069 Boehringer Ingelheim Investigational Site

Spring Hill, Tennessee, United States

Location

1275.1.01049 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1275.1.01080 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1275.1.01029 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1275.1.01053 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1275.1.01106 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1275.1.01018 Boehringer Ingelheim Investigational Site

Pearland, Texas, United States

Location

1275.1.01096 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1275.1.01113 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1275.1.01120 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1275.1.01105 Boehringer Ingelheim Investigational Site

Spring, Texas, United States

Location

1275.1.01037 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Location

1275.1.01008 Boehringer Ingelheim Investigational Site

Bountiful, Utah, United States

Location

1275.1.01022 Boehringer Ingelheim Investigational Site

West Jordan, Utah, United States

Location

1275.1.01091 Boehringer Ingelheim Investigational Site

South Chesterfield, Virginia, United States

Location

1275.1.01118 Boehringer Ingelheim Investigational Site

Selah, Washington, United States

Location

1275.1.01087 Boehringer Ingelheim Investigational Site

Shoreline, Washington, United States

Location

1275.1.01119 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1275.1.54001 Boehringer Ingelheim Investigational Site

Caba, Argentina

Location

1275.1.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1275.1.54003 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

Location

1275.1.54004 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

1275.1.54002 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

Location

1275.1.61003 Boehringer Ingelheim Investigational Site

Wollongong, New South Wales, Australia

Location

1275.1.61002 Boehringer Ingelheim Investigational Site

East Ringwood, Victoria, Australia

Location

1275.1.55002 Boehringer Ingelheim Investigational Site

Joaquim Távora, Brazil

Location

1275.1.55001 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, Brazil

Location

1275.1.55005 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1275.1.59003 Boehringer Ingelheim Investigational Site

Plovdiv, Bulgaria

Location

1275.1.59006 Boehringer Ingelheim Investigational Site

Rousse, Bulgaria

Location

1275.1.59004 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1275.1.20008 Boehringer Ingelheim Investigational Site

Bathurst, New Brunswick, Canada

Location

1275.1.20007 Boehringer Ingelheim Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

Location

1275.1.20006 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Location

1275.1.20004 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

1275.1.20001 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Location

1275.1.20005 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1275.1.20003 Boehringer Ingelheim Investigational Site

Drummondville, Quebec, Canada

Location

1275.1.20002 Boehringer Ingelheim Investigational Site

Pointe-Claire, Quebec, Canada

Location

1275.1.57004 Boehringer Ingelheim Investigational Site

Barranquilla, Colombia

Location

1275.1.57002 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1275.1.57005 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1275.1.57003 Boehringer Ingelheim Investigational Site

Tolima, Colombia

Location

1275.1.45004 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1275.1.45003 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1275.1.45002 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1275.1.37206 Boehringer Ingelheim Investigational Site

Kiviõli, Estonia

Location

1275.1.37202 Boehringer Ingelheim Investigational Site

Pärnu, Estonia

Location

1275.1.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1275.1.37204 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1275.1.37203 Boehringer Ingelheim Investigational Site

Viljandi County, Estonia

Location

1275.1.36002 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1275.1.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1275.1.36001 Boehringer Ingelheim Investigational Site

Gyöngyös, Hungary

Location

1275.1.39003 Boehringer Ingelheim Investigational Site

Bassano Del Grappa (VI), Italy

Location

1275.1.39002 Boehringer Ingelheim Investigational Site

Fermo, Italy

Location

1275.1.39001 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1275.1.39004 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1275.1.96004 Boehringer Ingelheim Investigational Site

Baabda, Lebanon

Location

1275.1.96002 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1275.1.96003 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1275.1.96006 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1275.1.96008 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1275.1.96007 Boehringer Ingelheim Investigational Site

Saida, Lebanon

Location

1275.1.60001 Boehringer Ingelheim Investigational Site

Kedah, Malaysia

Location

1275.1.60002 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1275.1.52002 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1275.1.52005 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1275.1.52003 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1275.1.52001 Boehringer Ingelheim Investigational Site

Pachuca, Mexico

Location

1275.1.52004 Boehringer Ingelheim Investigational Site

San Luis Potosí City, Mexico

Location

1275.1.51001 Boehringer Ingelheim Investigational Site

Arequipa, Peru

Location

1275.1.51003 Boehringer Ingelheim Investigational Site

Ica, Peru

Location

1275.1.51002 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1275.1.51004 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1275.1.51005 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1275.1.63002 Boehringer Ingelheim Investigational Site

Davao City, Philippines

Location

1275.1.63001 Boehringer Ingelheim Investigational Site

Greenhills, San Juan, Philippines

Location

1275.1.63004 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1275.1.63006 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1275.1.63003 Boehringer Ingelheim Investigational Site

Pasay, Philippines

Location

1275.1.63005 Boehringer Ingelheim Investigational Site

Pasig, Philippines

Location

1275.1.48002 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1275.1.48004 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1275.1.48001 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1275.1.48003 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1275.1.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, Romania

Location

1275.1.40005 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, Romania

Location

1275.1.40004 Boehringer Ingelheim Investigational Site

Brasov, Romania

Location

1275.1.40008 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1275.1.40009 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1275.1.40006 Boehringer Ingelheim Investigational Site

Cluj-Napoca, Romania

Location

1275.1.40007 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1275.1.40002 Boehringer Ingelheim Investigational Site

Oradea, Romania

Location

1275.1.40010 Boehringer Ingelheim Investigational Site

Sibiu, Romania

Location

1275.1.40003 Boehringer Ingelheim Investigational Site

Târgu Mureş, Romania

Location

1275.1.70006 Boehringer Ingelheim Investigational Site

Arkhangelsk, Russia

Location

1275.1.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1275.1.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1275.1.70003 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1275.1.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1275.1.70004 Boehringer Ingelheim Investigational Site

Samara, Russia

Location

1275.1.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1275.1.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1275.1.34002 Boehringer Ingelheim Investigational Site

Hospitalet de Llobegrat, Spain

Location

1275.1.34003 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

1275.1.34006 Boehringer Ingelheim Investigational Site

Tarragona, Spain

Location

1275.1.46003 Boehringer Ingelheim Investigational Site

Järfälla, Sweden

Location

1275.1.46004 Boehringer Ingelheim Investigational Site

Rättvik, Sweden

Location

1275.1.46002 Boehringer Ingelheim Investigational Site

Skene, Sweden

Location

1275.1.88006 Chang Gung Memorial Hospital-CY

Chiayi City, Taiwan

Location

1275.1.88007 E-Da Hospital

Kaohsiung City, Taiwan

Location

1275.1.88001 Cardinal Tien Hospital

New Taipei City, Taiwan

Location

1275.1.88004 Taichung Veterans General Hospital

Taichung, Taiwan

Location

1275.1.88008 Chi Mei Medical Center

Tainan, Taiwan

Location

1275.1.88002 Far Eastern Memorial Hospital

Taipei, Taiwan

Location

1275.1.88003 Taipei Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 29949041 DERIVED

• 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.

  PMID: 25633662 DERIVED

• 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.

  PMID: 25583754 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 25, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 2, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-03

Locations

TW (7); SE (3); RO (10); CO (4); CA (8); US (112); DK (3); HU (3); PL (4); ES (5); AU (2); ME (5); AR (5); MY (2); PE (5); LE (6); PH (6); BR (3); RU (6); IT (4); BU (3)