A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Overview[ - collapse ][ - ]
Purpose | This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: taspoglutide Drug: taspoglutide Drug: insulin glargine Drug: metformin |
Phase | Phase 3 |
Sponsor | Hoffmann-La Roche |
Responsible Party | Hoffmann-La Roche |
ClinicalTrials.gov Identifier | NCT00755287 |
First Received | September 17, 2008 |
Last Updated | April 7, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | September 17, 2008 |
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Last Updated Date | April 7, 2014 |
Start Date | November 2008 |
Estimated Primary Completion Date | March 2011 |
Current Primary Outcome Measures | Absolute change from baseline in HbA1c [Time Frame: 24 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea. |
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Official Title | A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy |
Brief Summary | This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: taspoglutide 10 mg once weekly Drug: taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) Drug: insulin glargine starting dose 10 IU daily Drug: metformin As prescribed |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 1072 |
Estimated Completion Date | March 2011 |
Estimated Primary Completion Date | March 2011 |
Eligibility Criteria | Inclusion Criteria: - adult patients, 18-75 years of age; - type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks; - C-peptide (fasting) >=1.0ng/mL; - HbA1c >=7.0% and <=10.0% at screening; - BMI >=25 (>23 for Asians) and <=45kg/m2 at screening; - stable weight +-5% for at least 12 weeks prior to screening. Exclusion Criteria: - history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; - evidence of clinically significant diabetic complications; - symptomatic poorly controlled diabetes; - clinically symptomatic gastrointestinal disease; - myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; - known hemoglobinopathy or chronic anemia. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Spain, Thailand, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00755287 |
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Other Study ID Numbers | BC20965 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Hoffmann-La Roche |
Study Sponsor | Hoffmann-La Roche |
Collaborators | Not Provided |
Investigators | Study Director: Clinical Trials Hoffmann-La Roche |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
United States, Arizona | Phoenix, Arizona, United States, 85032 |
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United States, Arkansas | Searcy, Arkansas, United States, 72143 |
United States, California | Concord, California, United States, 94520 |
United States, California | Huntington Beach, California, United States, 92648 |
United States, California | Los Angeles, California, United States, 90025 |
United States, California | Los Angeles, California, United States, 90015 |
United States, California | Los Gatos, California, United States, 95032 |
United States, California | Roseville, California, United States, 95661 |
United States, California | San Diego, California, United States, 92109 |
United States, California | Santa Ana, California, United States, 92705 |
United States, California | Westlake Village, California, United States, 91361 |
United States, District of Columbia | Washington, District of Columbia, United States, 20010 |
United States, Florida | Green Cove Springs, Florida, United States, 32043 |
United States, Florida | Hialeah, Florida, United States, 33013 |
United States, Florida | Jacksonville, Florida, United States, 32204 |
United States, Florida | Jacksonville, Florida, United States, 32216 |
United States, Florida | Ormond Beach, Florida, United States, 32174 |
United States, Florida | Oviedo, Florida, United States, 32765 |
United States, Florida | Palm Harbor, Florida, United States, 34684 |
United States, Florida | Trinity, Florida, United States, 34655 |
United States, Florida | Zephyrhills, Florida, United States, 33542 |
United States, Georgia | Atlanta, Georgia, United States, 30338 |
United States, Illinois | Quincy, Illinois, United States, 62301 |
United States, Illinois | Springfield, Illinois, United States, 62704-1433 |
United States, Indiana | Avon, Indiana, United States, 46123 |
United States, Indiana | Indianapolis, Indiana, United States, 46260 |
United States, Kansas | Arkansas City, Kansas, United States, 67005 |
United States, Kentucky | Crestview Hills, Kentucky, United States, 41017 |
United States, Louisiana | Metairie, Louisiana, United States, 70006 |
United States, Louisiana | Sunset, Louisiana, United States, 70584 |
United States, Maine | Portland, Maine, United States, 04101 |
United States, Maryland | North East, Maryland, United States, 21901 |
United States, Massachusetts | Worchester, Massachusetts, United States, 01605 |
United States, Michigan | St. Claire Shores, Michigan, United States, 48081 |
United States, Mississippi | Jackson, Mississippi, United States, 39216 |
United States, Mississippi | Picayune, Mississippi, United States, 39466 |
United States, Missouri | Springfield, Missouri, United States, 65807 |
United States, Nebraska | Grand Island, Nebraska, United States, 68803 |
United States, Nebraska | Omaha, Nebraska, United States, 68131 |
United States, Nebraska | Omaha, Nebraska, United States, 68105 |
United States, Nevada | Henderson, Nevada, United States, 89014 |
United States, New Jersey | Blackwood, New Jersey, United States, 08012 |
United States, New Jersey | Cherry Hill, New Jersey, United States, 08002 |
United States, New Jersey | Moorestown, New Jersey, United States, 08057 |
United States, New Jersey | Toms River, New Jersey, United States, 08753 |
United States, New Jersey | Toms River, New Jersey, United States, 08755 |
United States, New York | Albany, New York, United States, 12206-1098 |
United States, New York | Flushing, New York, United States, 11365 |
United States, New York | Mineola, New York, United States, 11501 |
United States, North Carolina | Asheville, North Carolina, United States, 28803 |
United States, North Carolina | Harrisburg, North Carolina, United States, 28075 |
United States, North Dakota | Fargo, North Dakota, United States, 58103 |
United States, Ohio | Centerville, Ohio, United States, 45459 |
United States, Ohio | Cincinnati, Ohio, United States, 45242 |
United States, Ohio | Genoa, Ohio, United States, 43430-1143 |
United States, Ohio | Toledo, Ohio, United States, 43606 |
United States, Pennsylvania | Altoona, Pennsylvania, United States, 16602 |
United States, Pennsylvania | Bensalem, Pennsylvania, United States, 19020 |
United States, Pennsylvania | Feasterville, Pennsylvania, United States, 19053 |
United States, Pennsylvania | Harrisburg, Pennsylvania, United States, 17112 |
United States, Pennsylvania | Jefferson Hills, Pennsylvania, United States, 15025 |
United States, Pennsylvania | Philadelphia, Pennsylvania, United States, 19107 |
United States, Pennsylvania | Philadelphia, Pennsylvania, United States, 19146 |
United States, Pennsylvania | Scranton, Pennsylvania, United States, 18510 |
United States, Pennsylvania | Tipton, Pennsylvania, United States, 16684 |
United States, South Carolina | Orangeburg, South Carolina, United States, 29115 |
United States, Tennessee | Johnson City, Tennessee, United States, 37604 |
United States, Texas | Dallas, Texas, United States, 75246 |
United States, Texas | Dallas, Texas, United States, 75390 |
United States, Texas | Dallas, Texas, United States, 75230 |
United States, Texas | Houston, Texas, United States, 77030 |
United States, Texas | Houston, Texas, United States, 77024 |
United States, Virginia | Richmond, Virginia, United States, 23249 |
United States, Wisconsin | Waukesha, Wisconsin, United States, 53189 |
Australia, New South Wales | St. Leonards, New South Wales, Australia, 2065 |
Australia, New South Wales | Wollongong, New South Wales, Australia, 2500 |
Australia, Queensland | Freemantle, Queensland, Australia, 6959 |
Austria | Graz, Austria, 8036 |
Austria | Salzburg, Austria, 5020 |
Austria | Wien, Austria, 1030 |
Austria | Wien, Austria, 1130 |
Austria | Wien, Austria, 1080 |
Belgium | Arlon, Belgium, 6700 |
Belgium | Bonheiden, Belgium, 2820 |
Belgium | Leuven, Belgium, 3000 |
Belgium | Liege, Belgium, 4000 |
Brazil, PE | Recife, PE, Brazil, 52051-380 |
Brazil, PR | Campina Grande do Sul, PR, Brazil, 83430-000 |
Brazil, PR | Curitiba, PR, Brazil, 80030-110 |
Brazil, RS | Porto Alegre, RS, Brazil, 90035-170 |
Brazil, SP | Sao Paulo, SP, Brazil, 04022-001 |
Canada, British Columbia | Vancouver, British Columbia, Canada, V5Z 1L8 |
Canada, Ontario | Hamilton, Ontario, Canada, L8S 4J9 |
Canada, Ontario | London, Ontario, Canada, N6A 5R8 |
Canada, Ontario | Toronto, Ontario, Canada, M5G 2C4 |
Canada, Quebec | Pointe-Claire, Quebec, Canada, H9R 4S3 |
Canada, Quebec | Sherbrooke, Quebec, Canada, J1G 5K2 |
Czech Republic | Brno, Czech Republic, 625 00 |
Czech Republic | Havirov, Czech Republic, 76301 |
Czech Republic | Plzen, Czech Republic, 301 00 |
Czech Republic | Praha, Czech Republic, 180 00 |
Czech Republic | Trutnov, Czech Republic, 541 01 |
Finland | Helsinki, Finland, 00150 |
Finland | Jyvaeskylae, Finland, 40100 |
Finland | Tampere, Finland, 33100 |
France | Avignon, France, 84902 |
France | Besancon, France, 25030 |
France | Bois Guillaume, France, 76233 |
France | Brest, France, 29609 |
France | Corbeil Essonnes, France, 91106 |
France | La Rochelle, France, 17019 |
France | Marseille, France, 13015 |
France | Marseille, France, 13385 |
France | Montpellier, France, 34295 |
France | Nimes, France, 30029 |
France | Paris, France, 75908 |
France | Paris, France, 75877 |
France | Paris, France, 75651 |
France | Strasbourg, France, 67091 |
France | Venissieux, France, 69200 |
Germany | Bad Lauterberg, Germany, 37431 |
Germany | Berlin, Germany, 10115 |
Germany | Bochum, Germany, 44869 |
Germany | Bosenheim, Germany, 55545 |
Germany | Dortmund, Germany, 44137 |
Germany | Falkensee, Germany, 14612 |
Germany | Freiburg, Germany, 79106 |
Germany | Mainz, Germany, 55116 |
Germany | Offenbach a.M., Germany, 63065 |
Germany | Reichenbach, Germany, 08468 |
Germany | Würzburg, Germany, 97072 |
Greece | Athens, Greece, 10552 |
Greece | Larissa, Greece, 41110 |
Greece | Thessaloniki, Greece, 56429 |
Guatemala | Guatemala, Guatemala, 01010 |
Hong Kong | Hong Kong, Hong Kong |
Hungary | Balatonfuered, Hungary, 8230 |
Hungary | Budapest, Hungary, 1045 |
Hungary | Szekszard, Hungary, 7100 |
Italy, Campania | Napoli, Campania, Italy, 80100 |
Italy, Lazio | Roma, Lazio, Italy, 00157 |
Italy, Lombardia | Codogno, Lombardia, Italy, 26845 |
Italy, Lombardia | Milano, Lombardia, Italy, 20132 |
Italy, Lombardia | Milano, Lombardia, Italy, 20142 |
Italy, Piemonte | Torino, Piemonte, Italy, 10126 |
Korea, Republic of | Daegu, Korea, Republic of, 700-721 |
Korea, Republic of | Incheon, Korea, Republic of |
Korea, Republic of | Seoul, Korea, Republic of, 137-040 |
Mexico | Aguascalientes, Mexico, 20127 |
Mexico | Cuernavaca, Mexico, 62250 |
Mexico | Monterrey, Mexico, 64410 |
Mexico | Tampico, Mexico, 89000 |
New Zealand | Auckland, New Zealand |
New Zealand | Auckland, New Zealand, 1640 |
Peru | Arequipa, Peru, Cercado |
Peru | Lima, Peru, Lima 33 |
Peru | Lima, Peru, Lima 1 |
Peru | Trujillo, Peru, 13011 |
Poland | Grodzisk Mazowiecki, Poland, 05-825 |
Poland | Kamieniec Zabkowicki, Poland, 57-230 |
Poland | Lodz, Poland, 93-338 |
Poland | Rzeszow, Poland, 35-073 |
Poland | Sobótka, Poland, 55-050 |
Poland | Szczecin, Poland, 71-455 |
Poland | Wroclaw, Poland, 51-124 |
Portugal | Coimbra, Portugal, 3000-075 |
Portugal | Lisboa, Portugal, 1250-203 |
Portugal | Lisboa, Portugal, 1349-019 |
Puerto Rico | Guyanabo, San Juan, Puerto Rico, 00920 |
Puerto Rico | Levittown, Puerto Rico, 00950 |
Puerto Rico | Orocovis, Puerto Rico, 00720 |
Puerto Rico | Ponce, Puerto Rico, 00717-322 |
Puerto Rico | San Juan, Puerto Rico, 00926-2832 |
Puerto Rico | Trujillo Alto, Puerto Rico, 00976 |
Russian Federation | Barnaul, Russian Federation, 656024 |
Russian Federation | Chelyabinsk, Russian Federation, 454136 |
Russian Federation | Moscow, Russian Federation, 117049 |
Russian Federation | Moscow, Russian Federation, 125299 |
Russian Federation | Moscow, Russian Federation, 129110 |
Russian Federation | Nizhny Novgorod, Russian Federation, 603126 |
Russian Federation | Novosibirsk, Russian Federation, 630047 |
Russian Federation | Omsk, Russian Federation, 644021 |
Russian Federation | Saint-Petersburg, Russian Federation, 197022 |
Russian Federation | St Petersburg, Russian Federation, 195213 |
Russian Federation | St-Petersburg, Russian Federation, 194291 |
Russian Federation | St. Petersburg, Russian Federation, 193012 |
Russian Federation | St. Petersburg, Russian Federation, 194354 |
Russian Federation | Tomsk, Russian Federation, 643050 |
Serbia | Belgrade, Serbia, 11000 |
Serbia | Kragujevac, Serbia, 34000 |
Serbia | Nis, Serbia, 18000 |
Serbia | Novi Sad, Serbia, 21000 |
Spain, Madrid | Pozuelo de alarcon, Madrid, Spain, 28223 |
Spain, Valencia | Alzira, Valencia, Spain, 46600 |
Spain | Almeria, Spain, 04001 |
Spain | Barcelona, Spain, 08025 |
Spain | Granada, Spain, 18012 |
Spain | Sevilla, Spain, 41013 |
Spain | Sevilla, Spain, 41010 |
Spain | Valencia, Spain, 46014 |
Spain | Valencia, Spain, 46010 |
Spain | Valladolid, Spain, 47005 |
Thailand | Bangkok, Thailand, 10330 |
Thailand | Bangkok, Thailand, 10400 |
United Kingdom | Atherstone, United Kingdom, CV9 1EU |
United Kingdom | Chesterfield, United Kingdom, S40 4TF |
United Kingdom | Dumfries, United Kingdom, DG1 4AP |
United Kingdom | Liverpool, United Kingdom, L9 7AL |
United Kingdom | Sheffield, United Kingdom, S18 1RU |
United Kingdom | Trowbridge, United Kingdom, BA14 8QA |