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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01422876
First received: August 23, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: BI 10773 high dose
Drug: high dose FDC placebo
Drug: linagliptin
Drug: low dose FDC placebo
Drug: high dose BI 10773 placebo
Drug: BI 10773 low dose
Drug: BI 10773 linagliptin FDC
Drug: linagliptin placebo
Drug: low dose BI 10773 placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Occurrence of treat to target efficacy response [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1406
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773/linagliptin FDC (high dose)
Patients receive BI 10773/linagliptin FDC (high dose) once daily
Drug: BI 10773
high dose monotherapy
Drug: linagliptin
montherapy
Drug: BI 10773 linagliptin FDC
low dose FDC
Drug: BI 10773 linagliptin FDC
high dose FDC
Drug: BI 10773
high dose montherapy
Drug: BI 10773
low dose montherapy
Experimental: BI 10773/linagliptin FDC (low dose)
Patients receive BI 10773/linagliptin FDC (low dose) once daily
Drug: high dose FDC placebo
once daily
Drug: linagliptin
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: low dose BI 10773 placebo
once daily
Drug: linagliptin placebo
once daily
Drug: BI 10773
low dose once daily
Active Comparator: BI 10773 (high dose)
Patients receive BI 10773 (high dose) once daily
Drug: BI 10773 high dose
once daily
Drug: high dose FDC placebo
once daily
Drug: low dose FDC placebo
once daily
Drug: low dose BI 10773 placebo
once daily
Drug: linagliptin placebo
once daily
Active Comparator: BI 10773 (low dose)
Patients receive BI 10773 (low dose) once daily
Drug: high dose FDC placebo
once daily
Drug: low dose FDC placebo
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: BI 10773 low dose
low dose once daily
Drug: linagliptin placebo
once daily
Active Comparator: Linagliptin
Patients receive linagliptin once daily
Drug: low dose FDC placebo
once daily
Drug: high dose FDC placebo
once daily
Drug: linagliptin
once daily
Drug: high dose BI 10773 placebo
once daily
Drug: low dose BI 10773 placebo
once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422876

  Hide Study Locations
Locations
United States, Alabama
1275.1.01103 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1275.1.01107 Boehringer Ingelheim Investigational Site
Foley, Alabama, United States
1275.1.01043 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1275.1.01066 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1275.1.01047 Boehringer Ingelheim Investigational Site
Pell City, Alabama, United States
United States, Arizona
1275.1.01089 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1275.1.01064 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
United States, Arkansas
1275.1.01028 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
United States, California
1275.1.01086 Boehringer Ingelheim Investigational Site
Cerritos, California, United States
1275.1.01067 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1275.1.01109 Boehringer Ingelheim Investigational Site
Encino, California, United States
1275.1.01012 Boehringer Ingelheim Investigational Site
Fresno, California, United States
1275.1.01050 Boehringer Ingelheim Investigational Site
Harbor City, California, United States
1275.1.01056 Boehringer Ingelheim Investigational Site
Huntington Park, California, United States
1275.1.01021 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1275.1.01024 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1275.1.01112 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1275.1.01083 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
1275.1.01071 Boehringer Ingelheim Investigational Site
San Dimas, California, United States
1275.1.01044 Boehringer Ingelheim Investigational Site
Tustin, California, United States
United States, Colorado
1275.1.01078 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1275.1.01124 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1275.1.01048 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1275.1.01010 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Florida
1275.1.01073 Boehringer Ingelheim Investigational Site
Gainesville, Florida, United States
1275.1.01077 Boehringer Ingelheim Investigational Site
Hialeah, Florida, United States
1275.1.01063 Boehringer Ingelheim Investigational Site
Hialeah, Florida, United States
1275.1.01090 Boehringer Ingelheim Investigational Site
Inverness, Florida, United States
1275.1.01054 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1275.1.01092 Boehringer Ingelheim Investigational Site
Maitland, Florida, United States
1275.1.01065 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1275.1.01110 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1275.1.01040 Boehringer Ingelheim Investigational Site
Miami Beach, Florida, United States
1275.1.01025 Boehringer Ingelheim Investigational Site
Miami Lakes, Florida, United States
1275.1.01094 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1275.1.01068 Boehringer Ingelheim Investigational Site
Ormond Beach, Florida, United States
1275.1.01051 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1275.1.01079 Boehringer Ingelheim Investigational Site
Port Orange, Florida, United States
1275.1.01117 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
United States, Georgia
1275.1.01039 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1275.1.01007 Boehringer Ingelheim Investigational Site
Marietta, Georgia, United States
1275.1.01111 Boehringer Ingelheim Investigational Site
Norcross, Georgia, United States
1275.1.01076 Boehringer Ingelheim Investigational Site
Savannah, Georgia, United States
United States, Illinois
1275.1.01100 Boehringer Ingelheim Investigational Site
Addison, Illinois, United States
United States, Iowa
1275.1.01042 Boehringer Ingelheim Investigational Site
Des Moines, Iowa, United States
United States, Kentucky
1275.1.01059 Boehringer Ingelheim Investigational Site
Paducah, Kentucky, United States
United States, Louisiana
1275.1.01003 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, Maryland
1275.1.01125 Boehringer Ingelheim Investigational Site
Hyattsville, Maryland, United States
United States, Massachusetts
1275.1.01081 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Michigan
1275.1.01085 Boehringer Ingelheim Investigational Site
Rochester, Michigan, United States
1275.1.01035 Boehringer Ingelheim Investigational Site
Southfield, Michigan, United States
United States, Missouri
1275.1.01027 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
1275.1.01023 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, Montana
1275.1.01033 Boehringer Ingelheim Investigational Site
Great Falls, Montana, United States
United States, Nevada
1275.1.01099 Boehringer Ingelheim Investigational Site
Henderson, Nevada, United States
1275.1.01123 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
1275.1.01114 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
1275.1.01101 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
United States, New Jersey
1275.1.01013 Boehringer Ingelheim Investigational Site
Elizabeth, New Jersey, United States
United States, New Mexico
1275.1.01057 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
1275.1.01002 Boehringer Ingelheim Investigational Site
Binghamton, New York, United States
1275.1.01020 Boehringer Ingelheim Investigational Site
Endwell, New York, United States
1275.1.01095 Boehringer Ingelheim Investigational Site
Flushing, New York, United States
1275.1.01062 Boehringer Ingelheim Investigational Site
Glens Falls, New York, United States
1275.1.01006 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, North Carolina
1275.1.01011 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina, United States
1275.1.01052 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
1275.1.01045 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
United States, Ohio
1275.1.01001 Boehringer Ingelheim Investigational Site
Akron, Ohio, United States
1275.1.01116 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1275.1.01061 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1275.1.01032 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1275.1.01016 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1275.1.01102 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1275.1.01036 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
1275.1.01017 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
1275.1.01030 Boehringer Ingelheim Investigational Site
Delaware, Ohio, United States
1275.1.01055 Boehringer Ingelheim Investigational Site
Groveport, Ohio, United States
1275.1.01075 Boehringer Ingelheim Investigational Site
Wadsworth, Ohio, United States
United States, Oklahoma
1275.1.01034 Boehringer Ingelheim Investigational Site
Norman, Oklahoma, United States
United States, Oregon
1275.1.01082 Boehringer Ingelheim Investigational Site
Corvallis, Oregon, United States
United States, Pennsylvania
1275.1.01084 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania, United States
1275.1.01038 Boehringer Ingelheim Investigational Site
Fleetwood, Pennsylvania, United States
1275.1.01019 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1275.1.01072 Boehringer Ingelheim Investigational Site
Scottdale, Pennsylvania, United States
1275.1.01088 Boehringer Ingelheim Investigational Site
Tipton, Pennsylvania, United States
1275.1.01060 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania, United States
1275.1.01014 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania, United States
United States, South Carolina
1275.1.01093 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1275.1.01122 Boehringer Ingelheim Investigational Site
Florence, South Carolina, United States
1275.1.01005 Boehringer Ingelheim Investigational Site
Hodges, South Carolina, United States
United States, Tennessee
1275.1.01015 Boehringer Ingelheim Investigational Site
Brentwood, Tennessee, United States
1275.1.01031 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee, United States
1275.1.01121 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1275.1.01069 Boehringer Ingelheim Investigational Site
Spring Hill, Tennessee, United States
United States, Texas
1275.1.01049 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1275.1.01080 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1275.1.01106 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1275.1.01053 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1275.1.01029 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1275.1.01018 Boehringer Ingelheim Investigational Site
Pearland, Texas, United States
1275.1.01113 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1275.1.01096 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1275.1.01120 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1275.1.01105 Boehringer Ingelheim Investigational Site
Spring, Texas, United States
1275.1.01037 Boehringer Ingelheim Investigational Site
Waco, Texas, United States
United States, Utah
1275.1.01008 Boehringer Ingelheim Investigational Site
Bountiful, Utah, United States
1275.1.01022 Boehringer Ingelheim Investigational Site
West Jordan, Utah, United States
United States, Virginia
1275.1.01091 Boehringer Ingelheim Investigational Site
South Chesterfield, Virginia, United States
United States, Washington
1275.1.01118 Boehringer Ingelheim Investigational Site
Selah, Washington, United States
1275.1.01087 Boehringer Ingelheim Investigational Site
Shoreline, Washington, United States
1275.1.01119 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
Argentina
1275.1.54001 Boehringer Ingelheim Investigational Site
Caba, Argentina
1275.1.54005 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1275.1.54003 Boehringer Ingelheim Investigational Site
Cordoba, Argentina
1275.1.54004 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1275.1.54002 Boehringer Ingelheim Investigational Site
Mendoza, Argentina
Australia, New South Wales
1275.1.61003 Boehringer Ingelheim Investigational Site
Wollongong, New South Wales, Australia
Australia, Victoria
1275.1.61002 Boehringer Ingelheim Investigational Site
East Ringwood, Victoria, Australia
Brazil
1275.1.55002 Boehringer Ingelheim Investigational Site
Joaquim Távora, Brazil
1275.1.55001 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ, Brazil
1275.1.55005 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Bulgaria
1275.1.59003 Boehringer Ingelheim Investigational Site
Plovdiv, Bulgaria
1275.1.59006 Boehringer Ingelheim Investigational Site
Ruse, Bulgaria
1275.1.59004 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
Canada, New Brunswick
1275.1.20008 Boehringer Ingelheim Investigational Site
Bathurst, New Brunswick, Canada
Canada, Newfoundland and Labrador
1275.1.20007 Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada
1275.1.20006 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
1275.1.20004 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
1275.1.20001 Boehringer Ingelheim Investigational Site
Brampton, Ontario, Canada
1275.1.20005 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1275.1.20003 Boehringer Ingelheim Investigational Site
Drummondville, Quebec, Canada
1275.1.20002 Boehringer Ingelheim Investigational Site
Pointe Claire, Quebec, Canada
Colombia
1275.1.57004 Boehringer Ingelheim Investigational Site
Barranquilla, Colombia
1275.1.57005 Boehringer Ingelheim Investigational Site
Bogota, Colombia
1275.1.57002 Boehringer Ingelheim Investigational Site
Bogotá, Colombia
1275.1.57003 Boehringer Ingelheim Investigational Site
Tolima, Colombia
Denmark
1275.1.45004 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
1275.1.45003 Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
1275.1.45002 Boehringer Ingelheim Investigational Site
København NV, Denmark
Estonia
1275.1.37206 Boehringer Ingelheim Investigational Site
Kivioli, Estonia
1275.1.37202 Boehringer Ingelheim Investigational Site
Pärnu, Estonia
1275.1.37204 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1275.1.37201 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1275.1.37203 Boehringer Ingelheim Investigational Site
Viljandi County, Estonia
Hungary
1275.1.36002 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1275.1.36003 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1275.1.36001 Boehringer Ingelheim Investigational Site
Gyongyos, Hungary
Italy
1275.1.39003 Boehringer Ingelheim Investigational Site
Bassano del Grappa (VI), Italy
1275.1.39002 Boehringer Ingelheim Investigational Site
Fermo, Italy
1275.1.39001 Boehringer Ingelheim Investigational Site
Milan, Italy
1275.1.39004 Boehringer Ingelheim Investigational Site
Roma, Italy
Lebanon
1275.1.96004 Boehringer Ingelheim Investigational Site
Baabda, Lebanon
1275.1.96003 Boehringer Ingelheim Investigational Site
Beirut, Lebanon
1275.1.96006 Boehringer Ingelheim Investigational Site
Beirut, Lebanon
1275.1.96008 Boehringer Ingelheim Investigational Site
Beirut, Lebanon
1275.1.96002 Boehringer Ingelheim Investigational Site
Beirut, Lebanon
1275.1.96007 Boehringer Ingelheim Investigational Site
Saida, Lebanon
Malaysia
1275.1.60001 Boehringer Ingelheim Investigational Site
Kedah, Malaysia
1275.1.60002 Boehringer Ingelheim Investigational Site
Perak, Malaysia
Mexico
1275.1.52005 Boehringer Ingelheim Investigational Site
Mexico, Mexico
1275.1.52002 Boehringer Ingelheim Investigational Site
Mexico, Mexico
1275.1.52003 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1275.1.52001 Boehringer Ingelheim Investigational Site
Pachuca, Mexico
1275.1.52004 Boehringer Ingelheim Investigational Site
San Luis Potosí, Mexico
Peru
1275.1.51001 Boehringer Ingelheim Investigational Site
Arequipa, Peru
1275.1.51003 Boehringer Ingelheim Investigational Site
Ica, Peru
1275.1.51005 Boehringer Ingelheim Investigational Site
Lima, Peru
1275.1.51004 Boehringer Ingelheim Investigational Site
Lima, Peru
1275.1.51002 Boehringer Ingelheim Investigational Site
Lima, Peru
Philippines
1275.1.63002 Boehringer Ingelheim Investigational Site
Davao, Philippines
1275.1.63001 Boehringer Ingelheim Investigational Site
Greenhills, San Juan, Philippines
1275.1.63004 Boehringer Ingelheim Investigational Site
Manila, Philippines
1275.1.63006 Boehringer Ingelheim Investigational Site
Marikina city, Philippines
1275.1.63003 Boehringer Ingelheim Investigational Site
Pasay City, Philippines
1275.1.63005 Boehringer Ingelheim Investigational Site
Pasig, Philippines
Poland
1275.1.48002 Boehringer Ingelheim Investigational Site
Lodz, Poland
1275.1.48004 Boehringer Ingelheim Investigational Site
Poznan, Poland
1275.1.48003 Boehringer Ingelheim Investigational Site
Warsaw, Poland
1275.1.48001 Boehringer Ingelheim Investigational Site
Warsaw, Poland
Romania
1275.1.40001 Boehringer Ingelheim Investigational Site
Alba Iulia, Romania
1275.1.40005 Boehringer Ingelheim Investigational Site
Baia Mare Maramures, Romania
1275.1.40004 Boehringer Ingelheim Investigational Site
Brasov, Romania
1275.1.40008 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1275.1.40009 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1275.1.40006 Boehringer Ingelheim Investigational Site
Cluj-Napoca, Romania
1275.1.40007 Boehringer Ingelheim Investigational Site
Galati, Romania
1275.1.40002 Boehringer Ingelheim Investigational Site
Oradea, Romania
1275.1.40010 Boehringer Ingelheim Investigational Site
Sibiu, Romania
1275.1.40003 Boehringer Ingelheim Investigational Site
Targu-Mures, Romania
Russian Federation
1275.1.70006 Boehringer Ingelheim Investigational Site
Arkhangelsk, Russian Federation
1275.1.70001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1275.1.70004 Boehringer Ingelheim Investigational Site
Samara, Russian Federation
1275.1.70005 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1275.1.70003 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1275.1.70002 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Spain
1275.1.34004 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1275.1.34005 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1275.1.34002 Boehringer Ingelheim Investigational Site
Hospitalet de Llobegrat, Spain
1275.1.34003 Boehringer Ingelheim Investigational Site
Palma de Mallorca, Spain
1275.1.34006 Boehringer Ingelheim Investigational Site
Tarragona, Spain
Sweden
1275.1.46003 Boehringer Ingelheim Investigational Site
Järfälla, Sweden
1275.1.46004 Boehringer Ingelheim Investigational Site
Rättvik, Sweden
1275.1.46002 Boehringer Ingelheim Investigational Site
Skene, Sweden
Taiwan
1275.1.88006 Chang Gung Memorial Hospital-CY
Chiayi, Taiwan
1275.1.88007 E-Da Hospital
Kaohsiung, Taiwan
1275.1.88001 Cardinal Tien Hospital
New Taipei, Taiwan
1275.1.88004 Taichung Veterans General Hospital
Taichung, Taiwan
1275.1.88008 Chi Mei Medical Center
Tainan, Taiwan
1275.1.88003 Taipei Chang Gung Memorial Hospital
Taipei, Taiwan
1275.1.88002 Far Eastern Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01422876     History of Changes
Other Study ID Numbers: 1275.1, 2011-000383-10
Study First Received: August 23, 2011
Last Updated: May 15, 2014
Health Authority: Argentina: Ministry of Health
Australia: Human Research Ethics Committee
Brazil: National Committee of Ethics in Research
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Denmark: The Danish Health and Medicines Authority
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Lebanon: Ministry of Public Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Linagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 30, 2014