A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
Overview[ - collapse ][ - ]
| Purpose | This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks 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 1-2 years, and the target sample size is 100-500 individuals. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: taspoglutide Drug: taspoglutide Drug: placebo Drug: pioglitazone Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Hoffmann-La Roche |
| Responsible Party | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier | NCT00744367 |
| First Received | August 29, 2008 |
| Last Updated | April 7, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 29, 2008 |
|---|---|
| Last Updated Date | April 7, 2014 |
| Start Date | October 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 Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone. |
|---|---|
| Official Title | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone |
| Brief Summary | This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks 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 1-2 years, and the target sample size is 100-500 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 10 mg sc once weekly; Drug: taspoglutide 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly) Drug: placebo sc once weekly Drug: pioglitazone >= 30 mg/day Drug: metformin >1500 mg/day or MTD |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 326 |
| Estimated Completion Date | March 2011 |
| Estimated Primary Completion Date | March 2011 |
| Eligibility Criteria | Inclusion Criteria: - adult patients, 18-75 years age; - type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening; - HbA1c >=7.0% and <=10.0% at screening; - BMI >= 25 (>23 for Asians) and <=45 kg/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, Brazil, Canada, Costa Rica, France, Germany, Guatemala, Mexico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00744367 |
|---|---|
| Other Study ID Numbers | BC20963 |
| 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, Alabama | Birmingham, Alabama, United States, 35294 |
|---|---|
| United States, Alabama | Birmingham, Alabama, United States, 35209 |
| United States, Alabama | Huntsville, Alabama, United States, 35801 |
| United States, Alabama | Muscle Shoals, Alabama, United States, 35661 |
| United States, Arizona | Phoenix, Arizona, United States, 85032 |
| United States, Arizona | Phoenix, Arizona, United States, 85028 |
| United States, California | Buena Park, California, United States, 90620 |
| United States, California | Lancaster, California, United States, 93534 |
| United States, California | Loma Linda, California, United States, 92354 |
| United States, California | Rancho Cucamonga, California, United States, 91730 |
| United States, California | Roseville, California, United States, 95661 |
| United States, California | San Diego, California, United States, 92161 |
| United States, California | Walnut Creek, California, United States, 94598 |
| United States, Colorado | Wheatridge, Colorado, United States, 80033 |
| United States, Connecticut | Hamden, Connecticut, United States, 06518 |
| United States, District of Columbia | Washington, District of Columbia, United States, 20017 |
| United States, Florida | Bradenton, Florida, United States, 34208 |
| United States, Florida | Chiefland, Florida, United States, 32626 |
| United States, Florida | Fort Myers, Florida, United States, 33907 |
| United States, Florida | Gainesville, Florida, United States, 32607 |
| United States, Florida | Hollywood, Florida, United States, 33021 |
| United States, Florida | Miami, Florida, United States, 33136 |
| United States, Florida | New Port Richey, Florida, United States, 34652 |
| United States, Florida | Ocala, Florida, United States, 34474 |
| United States, Florida | Plantation, Florida, United States, 33317 |
| United States, Florida | Tampa, Florida, United States, 33614 |
| United States, Idaho | Nampa, Idaho, United States, 83687 |
| United States, Illinois | Aurora, Illinois, United States, 60504 |
| United States, Illinois | Libertyville, Illinois, United States, 60048 |
| United States, Indiana | Evansville, Indiana, United States, 47714 |
| United States, Iowa | Des Moines, Iowa, United States, 50314 |
| United States, Kansas | Topeka, Kansas, United States, 66614 |
| United States, Kentucky | Lexington, Kentucky, United States, 40504 |
| United States, Kentucky | Madisonville, Kentucky, United States, 42431 |
| United States, Louisiana | New Orleans, Louisiana, United States, 70121 |
| United States, Maryland | Frederick, Maryland, United States, 21702 |
| United States, Maryland | Oxon Hill, Maryland, United States, 20745 |
| United States, Michigan | Detroit, Michigan, United States, 48202 |
| United States, Michigan | Ferndale, Michigan, United States, 48220 |
| United States, Michigan | Kalamazoo, Michigan, United States, 49048 |
| United States, Mississippi | Biloxi, Mississippi, United States, 39531 |
| United States, Mississippi | Olive Branch, Mississippi, United States, 38654 |
| United States, Missouri | St Peters, Missouri, United States, 63376 |
| United States, Nebraska | Omaha, Nebraska, United States, 68114 |
| United States, Nebraska | Omaha, Nebraska, United States, 68131 |
| United States, Nevada | Las Vegas, Nevada, United States, 89148 |
| United States, New York | Albany, New York, United States, 12206-1098 |
| United States, New York | Brooklyn, New York, United States, 11218 |
| United States, New York | Hudson, New York, United States, 12534 |
| United States, New York | Lake Success, New York, United States, 11042 |
| United States, New York | Staten Island, New York, United States, 10301 |
| United States, North Carolina | Charlotte, North Carolina, United States, 28262 |
| United States, North Carolina | Charlotte, North Carolina, United States, 28277 |
| United States, North Carolina | Mooresville, North Carolina, United States, 28117 |
| United States, North Carolina | Wilmington, North Carolina, United States, 28401 |
| United States, North Dakota | Bismarck, North Dakota, United States, 58501 |
| United States, Ohio | Athens, Ohio, United States, 45701 |
| United States, Ohio | Cincinnati, Ohio, United States, 45219 |
| United States, Ohio | Kettering, Ohio, United States, 45429 |
| United States, Oklahoma | Norman, Oklahoma, United States, 73071 |
| United States, Oregon | Medford, Oregon, United States, 97504 |
| United States, Pennsylvania | Beaver, Pennsylvania, United States, 15009 |
| United States, Pennsylvania | Bensalem, Pennsylvania, United States, 19020 |
| United States, Pennsylvania | Carlisle, Pennsylvania, United States, 17015 |
| United States, Pennsylvania | Levittown, Pennsylvania, United States, 19056 |
| United States, Pennsylvania | Melrose Park, Pennsylvania, United States, 19027 |
| United States, Pennsylvania | Pittsburgh, Pennsylvania, United States, 15236 |
| United States, Rhode Island | Cranston, Rhode Island, United States, 02920 |
| United States, South Carolina | Greer, South Carolina, United States, 29651 |
| United States, Texas | Bellaire, Texas, United States, 77401 |
| United States, Texas | Dallas, Texas, United States, 75230 |
| United States, Texas | Dallas, Texas, United States, 75231 |
| United States, Texas | Houston, Texas, United States, 77030 |
| United States, Texas | San Antonio, Texas, United States, 78205 |
| United States, Utah | Salt Lake City, Utah, United States, 84102 |
| United States, Washington | Federal Way, Washington, United States, 98003 |
| Brazil | Brasilia, Brazil, 70390-155 |
| Brazil | Forlateza, Brazil, 60430-350 |
| Brazil | Fortaleza, Brazil, 60430-370 |
| Brazil | Fortaleza, Brazil, 60120-021 |
| Brazil | Fortaleza, Brazil, 60155-290 |
| Brazil | Mogi Das Cruzes - Sp, Brazil, 08780-090 |
| Brazil | Passo Fundo, Brazil, 99010-901 |
| Brazil | Porto Alegre, Brazil, 90035-001 |
| Brazil | Recife, Brazil, 50100-130 |
| Brazil | Sao Paulo, Brazil, 04022-001 |
| Brazil | Sao Paulo, Brazil, 01244-030 |
| Brazil | Sao Paulo, Brazil, 05403-000 |
| Brazil | Sao Paulo, Brazil, 01221-020 |
| Canada, Newfoundland and Labrador | Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 |
| Canada, Ontario | Hamilton, Ontario, Canada, L8N 3Z5 |
| Canada, Ontario | London, Ontario, Canada, N6A 5R8 |
| Canada, Ontario | Toronto, Ontario, Canada, M9W 4L6 |
| Canada, Quebec | Montreal, Quebec, Canada, H2W 1T8 |
| Canada, Quebec | Pointe-claire, Quebec, Canada, H9R 4S3 |
| Costa Rica | San Jose, Costa Rica, 755-1000 |
| France | Bondy, France, 93143 |
| France | Dijon, France, 21079 |
| France | Nantes, France, 44093 |
| France | Narbonne, France, 11108 |
| Germany | Falkensee, Germany, 14612 |
| Germany | Karlsruhe, Germany, 76199 |
| Germany | Mainz, Germany, 55116 |
| Germany | Neuwied, Germany, 56564 |
| Germany | Potsdam, Germany, 14469 |
| Guatemala | Guatemala, Guatemala, 01010 |
| Guatemala | Guatemala, Guatemala |
| Mexico | Chihuahua, Mexico, 31238 |
| Mexico | Jalisco, Mexico, 44690 |
| Mexico | Mexico City, Mexico, 11650 |
| Puerto Rico | Carolina, Puerto Rico, 00983 |
| Puerto Rico | Guyanabo, San Juan, Puerto Rico, 00920 |
| Puerto Rico | San Juan, Puerto Rico, 00926-2832 |