- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01183013
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Harju, Estonia
- 1264.3.37207 Boehringer Ingelheim Investigational Site
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Pärnu, Estonia
- 1264.3.37209 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1264.3.37203 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1264.3.37204 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1264.3.37205 Boehringer Ingelheim Investigational Site
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Tallinn, Estonia
- 1264.3.37201 Boehringer Ingelheim Investigational Site
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Tallinn, Estonia
- 1264.3.37202 Boehringer Ingelheim Investigational Site
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Tallinn, Estonia
- 1264.3.37208 Boehringer Ingelheim Investigational Site
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Tartu, Estonia
- 1264.3.37206 Boehringer Ingelheim Investigational Site
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Viljandi County, Estonia
- 1264.3.37210 Boehringer Ingelheim Investigational Site
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Bad Lauterberg / Harz, Germany
- 1264.3.49001 Boehringer Ingelheim Investigational Site
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Dietzenbach, Germany
- 1264.3.49007 Boehringer Ingelheim Investigational Site
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Dortmund, Germany
- 1264.3.49002 Boehringer Ingelheim Investigational Site
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Essen, Germany
- 1264.3.49009 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
- 1264.3.49003 Boehringer Ingelheim Investigational Site
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Ingelheim, Germany
- 1264.3.49012 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
- 1264.3.49008 Boehringer Ingelheim Investigational Site
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Mainz, Germany
- 1264.3.49005 Boehringer Ingelheim Investigational Site
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Offenbach, Germany
- 1264.3.49010 Boehringer Ingelheim Investigational Site
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Stuhr, Germany
- 1264.3.49004 Boehringer Ingelheim Investigational Site
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Daugavpils, Latvia
- 1264.3.37105 Boehringer Ingelheim Investigational Site
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Daugavpils, Latvia
- 1264.3.37112 Boehringer Ingelheim Investigational Site
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Daugavpils, Latvia
- 1264.3.37113 Boehringer Ingelheim Investigational Site
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Jelgava, Latvia
- 1264.3.37110 Boehringer Ingelheim Investigational Site
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Liepaja, Latvia
- 1264.3.37101 Boehringer Ingelheim Investigational Site
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Ogre, Latvia
- 1264.3.37106 Boehringer Ingelheim Investigational Site
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Riga, Latvia
- 1264.3.37104 Boehringer Ingelheim Investigational Site
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Riga, Latvia
- 1264.3.37108 Boehringer Ingelheim Investigational Site
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Riga, Latvia
- 1264.3.37109 Boehringer Ingelheim Investigational Site
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Riga, Latvia
- 1264.3.37111 Boehringer Ingelheim Investigational Site
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Talsi, Latvia
- 1264.3.37107 Boehringer Ingelheim Investigational Site
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Tukums, Latvia
- 1264.3.37102 Boehringer Ingelheim Investigational Site
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Valmiera, Latvia
- 1264.3.37103 Boehringer Ingelheim Investigational Site
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Badía del Vallès - Barcelona, Spain
- 1264.3.34013 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
- 1264.3.34001 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
- 1264.3.34008 Boehringer Ingelheim Investigational Site
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Borges del Camp- Tarragona, Spain
- 1264.3.34005 Boehringer Ingelheim Investigational Site
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Canet de Mar - Barcelona, Spain
- 1264.3.34006 Boehringer Ingelheim Investigational Site
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Centelles - Barcelona, Spain
- 1264.3.34010 Boehringer Ingelheim Investigational Site
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L'Hospitalet de Llobregat, Spain
- 1264.3.34009 Boehringer Ingelheim Investigational Site
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L'Hospitalet de Llobregat - Barcelona, Spain
- 1264.3.34004 Boehringer Ingelheim Investigational Site
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Sant Adrià del Besós- Barcelona, Spain
- 1264.3.34002 Boehringer Ingelheim Investigational Site
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Tarrega - Lleida, Spain
- 1264.3.34007 Boehringer Ingelheim Investigational Site
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Valencia, Spain
- 1264.3.34012 Boehringer Ingelheim Investigational Site
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Vic - Barcelona, Spain
- 1264.3.34011 Boehringer Ingelheim Investigational Site
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Annan, United Kingdom
- 1264.3.44032 Boehringer Ingelheim Investigational Site
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Ash Vale, Aldershot, United Kingdom
- 1264.3.44028 Boehringer Ingelheim Investigational Site
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Baillieston, Glasgow, United Kingdom
- 1264.3.44029 Boehringer Ingelheim Investigational Site
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Balham, United Kingdom
- 1264.3.44008 Boehringer Ingelheim Investigational Site
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Bradford on Avon, United Kingdom
- 1264.3.44021 Boehringer Ingelheim Investigational Site
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Burbage, United Kingdom
- 1264.3.44019 Boehringer Ingelheim Investigational Site
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Chesterfield, United Kingdom
- 1264.3.44012 Boehringer Ingelheim Investigational Site
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Chestfield, Whitstable, United Kingdom
- 1264.3.44027 Boehringer Ingelheim Investigational Site
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Chippenham, United Kingdom
- 1264.3.44011 Boehringer Ingelheim Investigational Site
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Johnstone, United Kingdom
- 1264.3.44033 Boehringer Ingelheim Investigational Site
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Midsomer Norton, United Kingdom
- 1264.3.44007 Boehringer Ingelheim Investigational Site
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Paisley, United Kingdom
- 1264.3.44034 Boehringer Ingelheim Investigational Site
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Warminster, United Kingdom
- 1264.3.44031 Boehringer Ingelheim Investigational Site
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Alabama
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Birmingham, Alabama, United States
- 1264.3.01026 Boehringer Ingelheim Investigational Site
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Montgomery, Alabama, United States
- 1264.3.01021 Boehringer Ingelheim Investigational Site
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Muscle Shoals, Alabama, United States
- 1264.3.01020 Boehringer Ingelheim Investigational Site
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Arizona
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Chandler, Arizona, United States
- 1264.3.01062 Boehringer Ingelheim Investigational Site
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Mesa, Arizona, United States
- 1264.3.01064 Boehringer Ingelheim Investigational Site
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California
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Carmichael, California, United States
- 1264.3.01049 Boehringer Ingelheim Investigational Site
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Chino, California, United States
- 1264.3.01078 Boehringer Ingelheim Investigational Site
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Concord, California, United States
- 1264.3.01031 Boehringer Ingelheim Investigational Site
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Lakewood, California, United States
- 1264.3.01037 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
- 1264.3.01065 Boehringer Ingelheim Investigational Site
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Norwalk, California, United States
- 1264.3.01006 Boehringer Ingelheim Investigational Site
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Rancho Cucamonga, California, United States
- 1264.3.01001 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
- 1264.3.01059 Boehringer Ingelheim Investigational Site
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Tarzana, California, United States
- 1264.3.01023 Boehringer Ingelheim Investigational Site
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Tustin, California, United States
- 1264.3.01016 Boehringer Ingelheim Investigational Site
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Valencia, California, United States
- 1264.3.01058 Boehringer Ingelheim Investigational Site
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Westlake Village, California, United States
- 1264.3.01083 Boehringer Ingelheim Investigational Site
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Colorado
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Denver, Colorado, United States
- 1264.3.01027 Boehringer Ingelheim Investigational Site
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Connecticut
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Norwalk, Connecticut, United States
- 1264.3.01033 Boehringer Ingelheim Investigational Site
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Florida
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Boca Raton, Florida, United States
- 1264.3.01035 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
- 1264.3.01015 Boehringer Ingelheim Investigational Site
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Hialeah, Florida, United States
- 1264.3.01082 Boehringer Ingelheim Investigational Site
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Jacksonville, Florida, United States
- 1264.3.01036 Boehringer Ingelheim Investigational Site
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Longwood, Florida, United States
- 1264.3.01013 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1264.3.01038 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1264.3.01042 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1264.3.01079 Boehringer Ingelheim Investigational Site
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Port Orange, Florida, United States
- 1264.3.01019 Boehringer Ingelheim Investigational Site
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St. Cloud, Florida, United States
- 1264.3.01018 Boehringer Ingelheim Investigational Site
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Tampa, Florida, United States
- 1264.3.01009 Boehringer Ingelheim Investigational Site
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Tampa, Florida, United States
- 1264.3.01012 Boehringer Ingelheim Investigational Site
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Georgia
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Atlanta, Georgia, United States
- 1264.3.01008 Boehringer Ingelheim Investigational Site
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Atlanta, Georgia, United States
- 1264.3.01055 Boehringer Ingelheim Investigational Site
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Atlanta, Georgia, United States
- 1264.3.01061 Boehringer Ingelheim Investigational Site
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Blue Ridge, Georgia, United States
- 1264.3.01074 Boehringer Ingelheim Investigational Site
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Cartersville, Georgia, United States
- 1264.3.01084 Boehringer Ingelheim Investigational Site
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Perry, Georgia, United States
- 1264.3.01060 Boehringer Ingelheim Investigational Site
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Savannah, Georgia, United States
- 1264.3.01050 Boehringer Ingelheim Investigational Site
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Illinois
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Chicago, Illinois, United States
- 1264.3.01077 Boehringer Ingelheim Investigational Site
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Indiana
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Brownsburg, Indiana, United States
- 1264.3.01052 Boehringer Ingelheim Investigational Site
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Evansville, Indiana, United States
- 1264.3.01075 Boehringer Ingelheim Investigational Site
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Evansville, Indiana, United States
- 1264.3.01076 Boehringer Ingelheim Investigational Site
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Franklin, Indiana, United States
- 1264.3.01073 Boehringer Ingelheim Investigational Site
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Kansas
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Wichita, Kansas, United States
- 1264.3.01002 Boehringer Ingelheim Investigational Site
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Wichita, Kansas, United States
- 1264.3.01007 Boehringer Ingelheim Investigational Site
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Kentucky
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Lexington, Kentucky, United States
- 1264.3.01010 Boehringer Ingelheim Investigational Site
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Louisiana
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New Orleans, Louisiana, United States
- 1264.3.01028 Boehringer Ingelheim Investigational Site
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Sunset, Louisiana, United States
- 1264.3.01029 Boehringer Ingelheim Investigational Site
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Maryland
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Hyattsville, Maryland, United States
- 1264.3.01069 Boehringer Ingelheim Investigational Site
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Michigan
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Southfield, Michigan, United States
- 1264.3.01066 Boehringer Ingelheim Investigational Site
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Montana
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Great Falls, Montana, United States
- 1264.3.01057 Boehringer Ingelheim Investigational Site
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North Carolina
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Burlington, North Carolina, United States
- 1264.3.01045 Boehringer Ingelheim Investigational Site
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Charlotte, North Carolina, United States
- 1264.3.01044 Boehringer Ingelheim Investigational Site
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Ohio
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Zanesville, Ohio, United States
- 1264.3.01022 Boehringer Ingelheim Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- 1264.3.01032 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Fleetwood, Pennsylvania, United States
- 1264.3.01051 Boehringer Ingelheim Investigational Site
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Pittsburgh, Pennsylvania, United States
- 1264.3.01025 Boehringer Ingelheim Investigational Site
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South Carolina
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Columbia, South Carolina, United States
- 1264.3.01081 Boehringer Ingelheim Investigational Site
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Greer, South Carolina, United States
- 1264.3.01003 Boehringer Ingelheim Investigational Site
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Tennessee
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Kingsport, Tennessee, United States
- 1264.3.01011 Boehringer Ingelheim Investigational Site
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Texas
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Corpus Christi, Texas, United States
- 1264.3.01017 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
- 1264.3.01067 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1264.3.01004 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1264.3.01039 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1264.3.01041 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1264.3.01047 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
- 1264.3.01070 Boehringer Ingelheim Investigational Site
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Killeen, Texas, United States
- 1264.3.01040 Boehringer Ingelheim Investigational Site
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Midland, Texas, United States
- 1264.3.01048 Boehringer Ingelheim Investigational Site
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New Braunfels, Texas, United States
- 1264.3.01030 Boehringer Ingelheim Investigational Site
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North Richland Hills, Texas, United States
- 1264.3.01071 Boehringer Ingelheim Investigational Site
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Plano, Texas, United States
- 1264.3.01085 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
- 1264.3.01046 Boehringer Ingelheim Investigational Site
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Virginia
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Norfolk, Virginia, United States
- 1264.3.01056 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
- Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
- BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
- Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation
Exclusion criteria:
- Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
- Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
- Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
- Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
- Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
- Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)
Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :
- Diagnose of heart failure or history of heart failure
- Haemodialysis patients, due to limited experience with pioglitazone
- Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
- Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
- Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
- Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Participation in another trial with an investigational drug within 30 days prior to informed consent
- Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures
Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner
- Symptomatic gallbladder disease in the last six months
- Medical history of pancreatitis.
- Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
- Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
|
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
|
Active Comparator: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
|
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
|
Active Comparator: Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
|
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
|
Active Comparator: Linagliptin 5mg
Linagliptin 5mg Tablets once daily
|
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
|
Experimental: Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
|
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
|
Experimental: Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
|
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
|
Experimental: Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
|
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c After 30 Weeks of Treatment.
Time Frame: Baseline and 30 weeks
|
HbA1c is measured as a percentage.
The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
|
Baseline and 30 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Time Frame: Baseline and 30 weeks
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
|
Baseline and 30 weeks
|
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Time Frame: Baseline and 30 weeks
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
|
Baseline and 30 weeks
|
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Time Frame: Baseline and 30 weeks
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
|
Baseline and 30 weeks
|
HbA1c Change From Baseline by Visit Over Time
Time Frame: Baseline, week 6, week 12, week 18, week 24, week 30
|
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction. |
Baseline, week 6, week 12, week 18, week 24, week 30
|
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
Time Frame: Baseline and 30 weeks
|
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
|
Baseline and 30 weeks
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Time Frame: Baseline, week 6, week 12, week 18, week 24, week 30
|
The change from baseline is the FPG over time minus the baseline FPG.
Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
|
Baseline, week 6, week 12, week 18, week 24, week 30
|
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
Time Frame: Baseline and 30 weeks
|
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
|
Baseline and 30 weeks
|
Time to First Use of Rescue Therapy
Time Frame: 30 weeks
|
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
|
30 weeks
|
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Time Frame: 30 weeks
|
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
|
30 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Pioglitazone
- Linagliptin
Other Study ID Numbers
- 1264.3
- 2008-008127-15 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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