Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin). |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Alogliptin Drug: Placebo to alogliptin Drug: Metformin Drug: Pioglitazone |
Phase | Phase 3 |
Sponsor | Takeda |
Responsible Party | Takeda |
ClinicalTrials.gov Identifier | NCT01289119 |
First Received | February 1, 2011 |
Last Updated | February 17, 2013 |
Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | February 1, 2011 |
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Last Updated Date | February 17, 2013 |
Start Date | December 2010 |
Estimated Primary Completion Date | December 2011 |
Current Primary Outcome Measures | Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Time Frame: Baseline and Week 16.] [Designated as safety issue: No]The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes |
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Official Title | An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes |
Brief Summary | The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin). |
Detailed Description | Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality. 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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Alogliptin Alogliptin tablets Other Names: SYR-322Drug: Placebo to alogliptin Alogliptin placebo-matching tablets. Drug: Metformin Stable metformin dose Other Names:
Stable pioglitazone dose Other Names: Actos |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 506 |
Estimated Completion Date | December 2011 |
Estimated Primary Completion Date | December 2011 |
Eligibility Criteria | Inclusion Criteria: - Has a historical diagnosis of Type 2 Diabetes Mellitus. - 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 participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization. - 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China, Hong Kong, Taiwan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01289119 |
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Other Study ID Numbers | SYR-322_02 |
Has Data Monitoring Committee | No |
Information Provided By | Takeda |
Study Sponsor | Takeda |
Collaborators | Not Provided |
Investigators | Study Chair: Professor Study Chair Takeda |
Verification Date | February 2013 |
Locations[ + expand ][ + ]
China, Beijing | Beijing, Beijing, China |
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China, Fujian | Fuzhou, Fujian, China |
China, Fujian | Xiamen, Fujian, China |
China, Guangdong | Guangzhou, Guangdong, China |
China, Hainan | Haikou, Hainan, China |
China, Heilongjiang | Ha'erbin, Heilongjiang, China |
China, Hubei | Jingzhou, Hubei, China |
China, Hubei | Shiyan, Hubei, China |
China, Hunan | Changsha, Hunan, China |
China, Jiangsu | Wuxi, Jiangsu, China |
China, Jiangxi | Nanchang, Jiangxi, China |
China, Jilin | Changchun, Jilin, China |
China, Liaoning | Shenyang, Liaoning, China |
China, Shandong | Jinan, Shandong, China |
China, Shanghai | Shanghai, Shanghai, China |
China, Shanxi | Xi'an, Shanxi, China |
China, Tianjin | Tianjin, Tianjin, China |
China, Yunnan | Kunming, Yunnan, China |
China, Zhejiang | Hangzhou, Zhejiang, China |
Hong Kong | Hong Kong, Hong Kong |
Taiwan | Taipei County, Taiwan |