Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Alogliptin Drug: Metformin Drug: Glipizide |
Phase | Phase 3 |
Sponsor | Takeda |
Responsible Party | Takeda |
ClinicalTrials.gov Identifier | NCT00856284 |
First Received | March 4, 2009 |
Last Updated | September 25, 2013 |
Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | March 4, 2009 |
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Last Updated Date | September 25, 2013 |
Start Date | March 2009 |
Estimated Primary Completion Date | October 2012 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus |
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Official Title | A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes |
Brief Summary | The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients. |
Detailed Description | For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line therapy in addition to diet control and exercise. For those patients with inadequate glycemic control with metformin monotherapy or experiencing serious side effects of metformin, sulfonylurea is a popular choice as a second-line oral antidiabetic treatment. Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. This study is designed to further explore the durability of efficacy and safety of alogliptin compared to glipizide in type 2 diabetes mellitus patients whose blood sugar level is inadequately controlled with metformin therapy. The duration of this study will be approximately 2 years. |
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 | Type 2 Diabetes Mellitus |
Intervention | Drug: Alogliptin Alogliptin tablets Other Names:
Metformin tablets Other Names: GlucophageDrug: Glipizide Glipizide tablets Other Names: Glucotrol |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 2639 |
Estimated Completion Date | October 2012 |
Estimated Primary Completion Date | October 2012 |
Eligibility Criteria | Inclusion Criteria: - Has a diagnosis of type 2 diabetes mellitus. - Must meet one of the following: - Has been inadequately controlled on a stable daily dose of ≥1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening. - Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 - 10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose. - No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B). - Has body mass index within 23 kg/m^2 and 45 kg/m^2 unless the patient is Asian or of Asian descent, for whom the allowable body mass index will be ≥ 20 kg/m^2 and ≤ 35 kg/m^2, inclusive. - Has fasting C-peptide concentration at least 0.8 ng. - If regularly using non-excluded medications, must be on a stable dose at least 4 weeks prior to Screening/Pre-screening. - Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study. - Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments. Exclusion Criteria: - Systolic blood pressure greater than or equal to 150 mmHg and/or diastolic pressure greater than or equal to 90. - Hemoglobin less than or equal to 12 g/dL for males and less than or equal to 10 g/dL for females at Screening Visit. - Alanine aminotransferase greater than or equal to 2.5 times the upper limit of normal at Screening Visit. - Serum creatinine greater than or equal to 1.5 mg/dL for males and 1.4 for females, or calculated creatinine clearance less than 60 L/min. - Males intending to impregnate others or donate sperm before, during or within 1 month after participating in the study. - A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 years. - A history of laser treatment for diabetic retinopathy within 6 months of screening. - Treated for diabetic gastric paresis, gastric banding, or gastric bypass. - New York Heart Association Class III or IV heart failure. - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening. - Known history of human immunodeficiency virus, hepatitis B or C. - Alcohol or substance abuse within 2 years prior to screening. - Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: - Any investigational drug within 30 days - Any investigational diabetic drug within 3 months - Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening other than metformin - Prior treatment with alogliptin. - Weight-loss drugs - Oral or systemically injected glucocorticoids - A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide. - Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules). |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Argentina, Australia, Austria, Brazil, Canada, Chile, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Thailand, Ukraine, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00856284 |
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Other Study ID Numbers | SYR-322_305 |
Has Data Monitoring Committee | Yes |
Information Provided By | Takeda |
Study Sponsor | Takeda |
Collaborators | Not Provided |
Investigators | Study Director: Medical Director, Clinical Science Takeda |
Verification Date | September 2013 |
Locations[ + expand ][ + ]
United States, Alabama | Montgomery, Alabama, United States |
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United States, Alabama | Muscle Shoals, Alabama, United States |
United States, Alabama | Pell City, Alabama, United States |
United States, Arizona | Mesa, Arizona, United States |
United States, Arizona | Peoria, Arizona, United States |
United States, Arizona | Phoenix, Arizona, United States |
United States, Arizona | Sierra Vista, Arizona, United States |
United States, Arizona | Tempe, Arizona, United States |
United States, Arizona | Tucson, Arizona, United States |
United States, California | Anaheim, California, United States |
United States, California | Artesia, California, United States |
United States, California | Chico, California, United States |
United States, California | Los Alamitos, California, United States |
United States, California | Mission Viejo, California, United States |
United States, California | National City, California, United States |
United States, California | Northridge, California, United States |
United States, California | Pismo Beach, California, United States |
United States, California | Riverside, California, United States |
United States, California | Roseville, California, United States |
United States, California | Sacramento, California, United States |
United States, California | San Diego, California, United States |
United States, California | Santa Monica, California, United States |
United States, California | Tustin, California, United States |
United States, Colorado | Arvada, Colorado, United States |
United States, Colorado | Colorado Springs, Colorado, United States |
United States, Connecticut | Ridgefield, Connecticut, United States |
United States, Connecticut | Waterbury, Connecticut, United States |
United States, Florida | Brooksville, Florida, United States |
United States, Florida | New Port Richey, Florida, United States |
United States, Florida | North Miami Beach, Florida, United States |
United States, Florida | Ocala, Florida, United States |
United States, Florida | Opa Locka, Florida, United States |
United States, Florida | Orlando, Florida, United States |
United States, Georgia | Augusta, Georgia, United States |
United States, Georgia | Savannah, Georgia, United States |
United States, Illinois | Addison, Illinois, United States |
United States, Illinois | Chicago, Illinois, United States |
United States, Indiana | Bloomington, Indiana, United States |
United States, Indiana | Evansville, Indiana, United States |
United States, Indiana | Indianapolis, Indiana, United States |
United States, Indiana | Mishawaka, Indiana, United States |
United States, Indiana | South Bend, Indiana, United States |
United States, Kentucky | Lexington, Kentucky, United States |
United States, Kentucky | Munfordville, Kentucky, United States |
United States, Louisiana | Marrero, Louisiana, United States |
United States, Maine | Bangor, Maine, United States |
United States, Maryland | Elkridge, Maryland, United States |
United States, Maryland | Oxon Hill, Maryland, United States |
United States, Massachusetts | North Dartmouth, Massachusetts, United States |
United States, Michigan | Ann Arbor, Michigan, United States |
United States, Michigan | Flint, Michigan, United States |
United States, Mississippi | Picayune, Mississippi, United States |
United States, Missouri | Springfield, Missouri, United States |
United States, Missouri | St Peters, Missouri, United States |
United States, Missouri | St. Louis, Missouri, United States |
United States, Nebraska | Omaha, Nebraska, United States |
United States, Nevada | Las Vegas, Nevada, United States |
United States, New Mexico | Albuquerque, New Mexico, United States |
United States, New York | New Windsor, New York, United States |
United States, New York | New York, New York, United States |
United States, New York | Rochester, New York, United States |
United States, North Dakota | Fargo, North Dakota, United States |
United States, Ohio | Beachwood, Ohio, United States |
United States, Ohio | Cincinnati, Ohio, United States |
United States, Ohio | Dayton, Ohio, United States |
United States, Ohio | Willoughby Hills, Ohio, United States |
United States, Ohio | Zanesville, Ohio, United States |
United States, Oklahoma | Norman, Oklahoma, United States |
United States, Oklahoma | Oklahoma City, Oklahoma, United States |
United States, Oregon | Medford, Oregon, United States |
United States, Pennsylvania | Havertown, Pennsylvania, United States |
United States, Pennsylvania | Norristown, Pennsylvania, United States |
United States, Pennsylvania | Philadelphia, Pennsylvania, United States |
United States, Pennsylvania | Pittsburgh, Pennsylvania, United States |
United States, Pennsylvania | Tipton, Pennsylvania, United States |
United States, South Carolina | Anderson, South Carolina, United States |
United States, South Carolina | Charleston, South Carolina, United States |
United States, South Carolina | Greer, South Carolina, United States |
United States, South Dakota | Rapid City, South Dakota, United States |
United States, Tennessee | New Tazewell, Tennessee, United States |
United States, Texas | Arlington, Texas, United States |
United States, Texas | Carrollton, Texas, United States |
United States, Texas | Dallas, Texas, United States |
United States, Texas | Fort Worth, Texas, United States |
United States, Texas | Houston, Texas, United States |
United States, Texas | Hurst, Texas, United States |
United States, Texas | Katy, Texas, United States |
United States, Texas | San Antonio, Texas, United States |
United States, Texas | Spring, Texas, United States |
United States, Texas | Temple, Texas, United States |
United States, Utah | Midvale, Utah, United States |
United States, Virginia | Hampton, Virginia, United States |
United States, West Virginia | Lewisburg, West Virginia, United States |
United States, Wisconsin | Milwaukee, Wisconsin, United States |
Argentina | Mar del Plata, Argentina |
Australia, Australian Capital Territory | Garran, Australian Capital Territory, Australia |
Australia, New South Wales | Wollongong, New South Wales, Australia |
Australia, Queensland | Herston, Queensland, Australia |
Australia, Western Australia | Nedlands, Western Australia, Australia |
Austria | Graz, Austria |
Austria | Salzburg, Austria |
Brazil, Pernambuco | Recife, Pernambuco, Brazil |
Brazil, Planalto Central | Brasília - DF, Planalto Central, Brazil |
Brazil, São Paulo | Mogi das Cruzes, São Paulo, Brazil |
Brazil | Fortaleza, Brazil |
Brazil | São Paulo, Brazil |
Canada, Newfoundland and Labrador | St. John's, Newfoundland and Labrador, Canada |
Canada, Ontario | Brampton, Ontario, Canada |
Canada, Ontario | Collingwood, Ontario, Canada |
Canada, Ontario | Corunna, Ontario, Canada |
Canada, Ontario | Etobichoke, Ontario, Canada |
Canada, Ontario | Etobicoke, Ontario, Canada |
Canada, Ontario | Mississauga, Ontario, Canada |
Canada, Ontario | Smith Falls, Ontario, Canada |
Canada, Ontario | Smiths Falls, Ontario, Canada |
Canada, Ontario | Toronto, Ontario, Canada |
Canada, Quebec | Granby, Quebec, Canada |
Canada, Quebec | Montreal, Quebec, Canada |
Chile, Santiago | Providencia, Santiago, Chile |
Chile | Santiago, Chile |
Germany, Brandenburg | Potsdam, Brandenburg, Germany |
Germany, Hesse | Kelkheim, Hesse, Germany |
Germany, Hesse | Offenbach, Hesse, Germany |
Germany, North Rhine-Westphalia | Münster, North Rhine-Westphalia, Germany |
Germany, Rhineland-Palatinate | Mainz, Rhineland-Palatinate, Germany |
Germany, Rhineland-Palatinate | Neuwied, Rhineland-Palatinate, Germany |
Germany, Rhineland-Palatinate | Rhaunen, Rhineland-Palatinate, Germany |
Guatemala | Guatemala City, Guatemala |
Hong Kong, Kowloon | Wong Tai Sin, Kowloon, Hong Kong |
Hong Kong, Southern District | Pok Fu Lam, Southern District, Hong Kong |
Hong Kong | Kowloon, Hong Kong |
Hungary, Baranya | Pécs, Baranya, Hungary |
Hungary, Borsod-Abaúj-Zemplén | Miskolc, Borsod-Abaúj-Zemplén, Hungary |
Hungary, Bács-Kiskun | Kalocsa, Bács-Kiskun, Hungary |
Hungary, Békés | Gyula, Békés, Hungary |
Hungary, Csongrád | Makó, Csongrád, Hungary |
Hungary, Csongrád | Szentes, Csongrád, Hungary |
Hungary, Szabolcs-Szatmár-Bereg | Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary |
Hungary, Zala | Zalaegerszeg, Zala, Hungary |
Hungary | Budapest, Hungary |
India, Andhra Pradesh | Hyderabad, Andhra Pradesh, India |
India, Bihar | Patna, Bihar, India |
India, Haryana | Karnal, Haryana, India |
India, Karnataka | Bangalore, Karnataka, India |
India, Karnataka | Belgaum, Karnataka, India |
India, Madhya Pradesh | Bhopal, Madhya Pradesh, India |
India, Maharashtra | Mumbai, Maharashtra, India |
India, Tamil Nadu | Trichy, Tamil Nadu, India |
Israel, Center District | Kfar-Saba, Center District, Israel |
Israel, Central District | Kfar Saba, Central District, Israel |
Israel, Central District | Matan, Central District, Israel |
Israel, Central District | Petach Tikva, Central District, Israel |
Israel, Haifa District | Hadera, Haifa District, Israel |
Israel, Haifa District | Haifa, Haifa District, Israel |
Israel, Northern District | Nahariya, Northern District, Israel |
Israel, Northern District | Safed, Northern District, Israel |
Israel, Southern District | Ashkelon, Southern District, Israel |
Israel, Southern District | Be'er Sheva, Southern District, Israel |
Israel, Tel Aviv | Holon, Tel Aviv, Israel |
Israel, Tel Aviv | Tel- Aviv, Tel Aviv, Israel |
Israel | Jerusalem, Israel |
Israel | Zefat, Israel |
Italy, Milan | Milano, Milan, Italy |
Italy | Perugia, Italy |
Italy | Pistoia, Italy |
Korea, Republic of, Honam | Gwangju, Honam, Korea, Republic of |
Korea, Republic of, Hoseo | Daejeon, Hoseo, Korea, Republic of |
Korea, Republic of, Yeongnam | Daegu, Yeongnam, Korea, Republic of |
Latvia | Daugavpils, Latvia |
Latvia | Liepaja, Latvia |
Latvia | Limbazi, Latvia |
Latvia | Ogre, Latvia |
Latvia | Riga, Latvia |
Latvia | Talsi, Latvia |
Latvia | Tukums, Latvia |
Latvia | Valmiera, Latvia |
Lithuania | Alytus, Lithuania |
Lithuania | Kaunas, Lithuania |
Lithuania | Kedainiai, Lithuania |
Lithuania | Klaipeda, Lithuania |
Lithuania | Palanga, Lithuania |
Lithuania | Panevezys, Lithuania |
Lithuania | Vilnius, Lithuania |
Malaysia | Ipoh, Malaysia |
Malaysia | Kajang, Malaysia |
Malaysia | Kota Bahru, Malaysia |
Malaysia | Kota Bharu, Malaysia |
Malaysia | Kuala Terengganu, Malaysia |
Malaysia | Kuantan, Malaysia |
Malaysia | Melaka, Malaysia |
Malaysia | Taiping, Malaysia |
Mexico, Distrito Federal | Mexico, Distrito Federal, Mexico |
Mexico, Edo de Mexico | Tlalnepantla, Edo de Mexico, Mexico |
Mexico, Jalisco | Guadalajara, Jalisco, Mexico |
Mexico, Nuevo Leon | Monterrey, Nuevo Leon, Mexico |
Mexico | Huixquilucan Edo. de Mexico, Mexico |
Mexico | Mexico City, Mexico |
New Zealand | Auckland, New Zealand |
New Zealand | Christchurch, New Zealand |
New Zealand | Hamilton, New Zealand |
New Zealand | Otahuhu, New Zealand |
New Zealand | Palmerston North, New Zealand |
New Zealand | Takapuna, New Zealand |
New Zealand | Tauranga, New Zealand |
New Zealand | Wellington, New Zealand |
Peru, Lambayeque | Chiclayo, Lambayeque, Peru |
Peru, San Juan de Miraflores | Lima, San Juan de Miraflores, Peru |
Peru | Ica, Peru |
Philippines | Manila, Philippines |
Poland | Bytom, Poland |
Poland | Gniewkowo, Poland |
Poland | Krakow, Poland |
Poland | Radom, Poland |
Poland | Rzeszow, Poland |
Poland | Tychy, Poland |
Poland | Warszawa, Poland |
Puerto Rico | Ponce, Puerto Rico |
Puerto Rico | San Juan, Puerto Rico |
Romania | Bacau, Romania |
Romania | Bucharest, Romania |
Romania | Galati, Romania |
Romania | Oradea, Romania |
Romania | Sibiu, Romania |
Romania | Targu Mures, Romania |
Russian Federation | Arkhangelsk, Russian Federation |
Russian Federation | Irkutsk, Russian Federation |
Russian Federation | Moscow, Russian Federation |
Russian Federation | Samara, Russian Federation |
Russian Federation | Smolensk, Russian Federation |
Russian Federation | St Petersburg, Russian Federation |
Russian Federation | Yaroslavl, Russian Federation |
Singapore | Singapore, Singapore |
South Africa, Eastern Cape | Port Elizabeth, Eastern Cape, South Africa |
South Africa, Gauteng | Johannesburg, Gauteng, South Africa |
South Africa, Gauteng | Pretoria, Gauteng, South Africa |
South Africa, Kwazulu-Natal | Durban, Kwazulu-Natal, South Africa |
South Africa, Kwazulu-Natal | Tongaat, Kwazulu-Natal, South Africa |
South Africa, Western Cape | Cape Town, Western Cape, South Africa |
Spain, Cataluña | Barcelona, Cataluña, Spain |
Spain, Galicia | Santiago de Compostela, Galicia, Spain |
Spain | Alicante, Spain |
Thailand | Amphure Muang, Thailand |
Thailand | Bangkok, Thailand |
Thailand | Chiangmai, Thailand |
Thailand | Khon Kaen, Thailand |
Ukraine | Dnepropertovsk, Ukraine |
Ukraine | Dnipropetrovsk, Ukraine |
Ukraine | Donetsk, Ukraine |
Ukraine | Kharkiv, Ukraine |
Ukraine | Kyiv, Ukraine |
Ukraine | Lviv, Ukraine |
Ukraine | Vinnytsa, Ukraine |
Ukraine | Vinnytsya, Ukraine |
Ukraine | Zaporizhye, Ukraine |
Ukraine | Zaporizhzhya, Ukraine |
United Kingdom | Aintree-Liverpool, United Kingdom |
United Kingdom | Bath, United Kingdom |
United Kingdom | Bournemouth, United Kingdom |
United Kingdom | Dundee, United Kingdom |
United Kingdom | London, United Kingdom |
United Kingdom | Stevenage, United Kingdom |
United Kingdom | Swansea, United Kingdom |