A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Overview[ - collapse ][ - ]
Purpose | This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: taspoglutide Drug: taspoglutide Drug: sitagliptin Drug: placebo Drug: metformin Drug: placebo |
Phase | Phase 3 |
Sponsor | Hoffmann-La Roche |
Responsible Party | Hoffmann-La Roche |
ClinicalTrials.gov Identifier | NCT00754988 |
First Received | September 17, 2008 |
Last Updated | October 17, 2011 |
Last verified | October 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | September 17, 2008 |
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Last Updated Date | October 17, 2011 |
Start Date | October 2008 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Mean changes 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 Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin. |
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Official Title | A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin. |
Brief Summary | This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 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: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: taspoglutide 10mg sc once weekly Drug: taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) Drug: sitagliptin 100mg po once daily Drug: placebo sc once weekly Drug: metformin As prescribed Drug: placebo po once daily |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 666 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - adult patients, 18-75 years of age; - type 2 diabetes receiving metformin (>=1500mg/day) for at least 12 weeks; - 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; - 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, Argentina, Australia, Canada, France, Germany, Greece, Korea, Republic of, Mexico, Norway, Peru, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00754988 |
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Other Study ID Numbers | BC21713 |
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 | October 2011 |
Locations[ + expand ][ + ]
United States, Alabama | Birmingham, Alabama, United States, 35233 |
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United States, Alabama | Huntsville, Alabama, United States, 35802 |
United States, Alabama | Tallassee, Alabama, United States, 36078 |
United States, Arizona | Scottsdale, Arizona, United States, 85254 |
United States, Arkansas | Little Rock, Arkansas, United States, 72205 |
United States, California | Huntington Beach, California, United States, 92646 |
United States, California | La Jolla, California, United States, 92037 |
United States, California | Los Angeles, California, United States, 90017 |
United States, California | Roseville, California, United States, 95661 |
United States, California | San Francisco, California, United States, 94109 |
United States, California | Tacoma, California, United States, 98405 |
United States, Colorado | Colorado Springs, Colorado, United States, 80904 |
United States, Connecticut | New London, Connecticut, United States, 06320 |
United States, District of Columbia | Manati, District of Columbia, United States, 00674 |
United States, Florida | Daytona Beach, Florida, United States, 32117 |
United States, Florida | Hialeah, Florida, United States, 33012 |
United States, Florida | Jacksonville, Florida, United States, 32205 |
United States, Florida | Miami, Florida, United States, 33186 |
United States, Florida | Panama City, Florida, United States, 32401 |
United States, Florida | St Petersburg, Florida, United States, 33606 |
United States, Georgia | Augusta, Georgia, United States, 30904 |
United States, Georgia | Conyers, Georgia, United States, 30094 |
United States, Georgia | Snellville, Georgia, United States, 30029 |
United States, Hawaii | Honolulu, Hawaii, United States, 96813 |
United States, Indiana | Indianapolis, Indiana, United States, 46229 |
United States, Indiana | Indianapolis, Indiana, United States, 46254 |
United States, Indiana | Lafayette, Indiana, United States, 47904 |
United States, Indiana | South Bend, Indiana, United States, 46628 |
United States, Maryland | Baltimore, Maryland, United States, 21229 |
United States, Massachusetts | Brockton, Massachusetts, United States, 02301 |
United States, Michigan | Cadillac, Michigan, United States, 49601 |
United States, Minnesota | Brooklyn Center, Minnesota, United States, 55430 |
United States, Minnesota | Minneapolis, Minnesota, United States, 55416 |
United States, Missouri | St. Peters, Missouri, United States, 63376 |
United States, New York | Fulton, New York, United States, 13069 |
United States, New York | Hudson, New York, United States, 12534 |
United States, New York | Rochester, New York, United States, 14609 |
United States, North Carolina | Charlotte, North Carolina, United States, 28211 |
United States, North Carolina | Raleigh, North Carolina, United States, 27609 |
United States, North Carolina | Shelby, North Carolina, United States, 28150 |
United States, North Carolina | Statesville, North Carolina, United States, 28625 |
United States, North Carolina | Winston-salem, North Carolina, United States, 27103 |
United States, Ohio | Columbus, Ohio, United States, 43213 |
United States, Ohio | Delaware, Ohio, United States, 43015 |
United States, Ohio | Marion, Ohio, United States, 43302 |
United States, Oregon | Corvallis, Oregon, United States, 97330 |
United States, Oregon | Eugene, Oregon, United States, 97401 |
United States, Pennsylvania | Aliquippa, Pennsylvania, United States, 15001 |
United States, Pennsylvania | Beaver, Pennsylvania, United States, 15009 |
United States, Pennsylvania | Erie, Pennsylvania, United States, 16508 |
United States, Pennsylvania | Reading, Pennsylvania, United States, 17601 |
United States, Pennsylvania | Reading, Pennsylvania, United States, 19606 |
United States, Pennsylvania | Shippensburg, Pennsylvania, United States, 17257 |
United States, Pennsylvania | Warminster, Pennsylvania, United States, 18974 |
United States, South Carolina | Anderson, South Carolina, United States, 29621 |
United States, Tennessee | Kingsport, Tennessee, United States, 37660 |
United States, Texas | Dallas, Texas, United States, 75230 |
United States, Texas | Houston, Texas, United States, 77030 |
United States, Vermont | South Burlington, Vermont, United States, 05403 |
United States, Virginia | Hampton, Virginia, United States, 23666 |
United States, Virginia | Norfolk, Virginia, United States, 23502 |
United States, Virginia | Richmond, Virginia, United States, 23294 |
United States, Virginia | Richmond, Virginia, United States, 23249 |
United States, Washington | Federal Way, Washington, United States, 98003 |
Argentina | Buenos Aires, Argentina, C1012 |
Argentina | Buenos Aires, Argentina, C1213AAH |
Argentina | Mar Del Plata, Argentina, B7600GNY |
Australia | Adelaide, Australia, 5000 |
Australia | Freemantle, Australia, 6959 |
Canada, Ontario | London, Ontario, Canada, NGA 4V2 |
Canada, Ontario | Thornhill, Ontario, Canada, L4J 8L7 |
Canada, Ontario | Toronto, Ontario, Canada, M9W 4L6 |
Canada | Montreal, Canada, H2W 1T8 |
Canada | Pointe-claire, Canada, H9R 4S3 |
France | Bondy, France, 93143 |
France | Nantes, France, 44093 |
France | Poitiers, France, 86021 |
France | Rennes, France, 35203 |
France | Saint-mandé, France, 94160 |
Germany | Berlin, Germany, 10115 |
Germany | Dormagen, Germany, 41539 |
Germany | Dresden, Germany, 01307 |
Germany | Kiel Kronshagen, Germany, 24119 |
Germany | München, Germany, 80336 |
Germany | Sulzbach-rosenberg, Germany, 92237 |
Germany | Villingen-schwenningen, Germany, 78048 |
Greece | Larissa, Greece, 41110 |
Korea, Republic of | Gyeonggi-do, Korea, Republic of |
Korea, Republic of | Kangwon-do, Korea, Republic of, 220-701 |
Korea, Republic of | Seoul, Korea, Republic of, 152-703 |
Korea, Republic of | Seoul, Korea, Republic of |
Korea, Republic of | Suwon City, Korea, Republic of, 443-721 |
Mexico | Cuernavaca, Mexico, 62250 |
Mexico | Hermosillo, Mexico, 83200 |
Mexico | Jalisco, Mexico, 44690 |
Mexico | Mexico City, Mexico, 11520 |
Mexico | Mexico City, Mexico, 06700 |
Mexico | Monterrey, Mexico, 64000 |
Mexico | Pachuca, Mexico, 42086 |
Norway | Elverum, Norway, 2401 |
Norway | Oslo, Norway, 0176 |
Norway | Oslo, Norway, 0407 |
Norway | Oslo, Norway, 0027 |
Peru | Lima, Peru, Lima 33 |
Peru | Lima, Peru, Lima 9 |
Poland | Bialystok, Poland, 15-445 |
Poland | Gdansk, Poland, 80-858 |
Poland | Kamieniec Zabkowicki, Poland, 57-230 |
Poland | Rzeszow, Poland, 35-073 |
Poland | Skierniewice, Poland, 96-100 |
Poland | Sobótka, Poland, 55-050 |
Poland | Wroclaw, Poland, 51-124 |
Puerto Rico | Caguas, Puerto Rico, 00725 |
Puerto Rico | Carolina, Puerto Rico, 00983 |
Romania | Bucuresti, Romania, 020359 |
Romania | Buzau, Romania, 120203 |
Romania | Cluj-napoca, Romania, 400006 |
Romania | Ploiesti, Romania, 100163 |
Romania | Ploiesti, Romania, 100342 |
Slovakia | Levice, Slovakia, 93405 |
Slovakia | Presov, Slovakia, 080 01 |
Slovakia | Samorin, Slovakia, 931 01 |
Slovakia | Trebisov, Slovakia, 07501 |
Slovakia | Trencin, Slovakia, 911 01 |
South Africa | Pretoria, South Africa, 0002 |
South Africa | Somerset West, South Africa, 7130 |
Spain | Almeria, Spain, 04001 |
Spain | Bacarot Alicant, Spain, 03114 |
Spain | Sevilla, Spain, 41010 |
Spain | Valencia, Spain, 46014 |
Sweden | Ljungby, Sweden, 34182 |
Sweden | Stockholm, Sweden, 14186 |
Sweden | Örebro, Sweden, 701 85 |
Switzerland | Basel, Switzerland, 4051 |
Switzerland | Geneve, Switzerland, 1211 |
Switzerland | Zürich, Switzerland, 8063 |
Taiwan | Taichung, Taiwan, 407 |
Taiwan | Taipei, Taiwan, 114 |
Taiwan | Taipei, Taiwan, 220 |
Taiwan | Taoyuan County, Taiwan, 333 |
Thailand | Bangkok, Thailand, 10330 |
Thailand | Songkla, Thailand, 90112 |
Turkey | Istanbul, Turkey, 34390 |
United Kingdom | Bexhill on Sea, United Kingdom, TN39 4SP |
United Kingdom | Crawley, United Kingdom, RH10 7DX |
United Kingdom | Glasgow, United Kingdom, G46 8NY |
United Kingdom | Hinckley, United Kingdom, LE10 2SE |
United Kingdom | Reading, United Kingdom, RG7 3SQ |