Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
NCT ID: NCT01289119
Last Updated: 2013-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
506 participants
INTERVENTIONAL
2010-12-31
2011-12-31
Brief Summary
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Detailed Description
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Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.
Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.
Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.
* Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
* Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
* Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Placebo to alogliptin
Alogliptin placebo-matching tablets.
Alogliptin Monotherapy
Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Alogliptin
Alogliptin tablets
Metformin
Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Placebo to alogliptin
Alogliptin placebo-matching tablets.
Metformin
Stable metformin dose
Metformin + Alogliptin Add-on Therapy
Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Alogliptin
Alogliptin tablets
Metformin
Stable metformin dose
Pioglitazone
Participants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Placebo to alogliptin
Alogliptin placebo-matching tablets.
Pioglitazone
Stable pioglitazone dose
Pioglitazone + Alogliptin Add-on Therapy
Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
Alogliptin
Alogliptin tablets
Pioglitazone
Stable pioglitazone dose
Interventions
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Alogliptin
Alogliptin tablets
Placebo to alogliptin
Alogliptin placebo-matching tablets.
Metformin
Stable metformin dose
Pioglitazone
Stable pioglitazone dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a body mass index between acceptable range.
* Is experiencing inadequate glycemic control.
* Body weight keeps constant.
* Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
Exclusion Criteria
* Has a systolic blood pressure beyond the acceptable range at Screening visit.
* Has New York Heart Association Class III or IV heart failure regardless of therapy.
* Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
* Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.
18 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Study Chair
Role: STUDY_CHAIR
Takeda
Locations
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Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Haikou, Hainan, China
Harbin, Heilongjiang, China
Jingzhou, Hubei, China
Shiyan, Hubei, China
Changsha, Hunan, China
Wuxi, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Shanghai, Shanghai Municipality, China
Xi’an, Shanxi, China
Tianjin, Tianjin Municipality, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Hong Kong, Hong Kong, Hong Kong
Taipei County, , Taiwan
Countries
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References
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El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
Other Identifiers
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U1111-1118-3681
Identifier Type: REGISTRY
Identifier Source: secondary_id
SYR-322_308
Identifier Type: OTHER
Identifier Source: secondary_id
SYR-322_02
Identifier Type: -
Identifier Source: org_study_id
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