| Trial ID: | L4325 |
| Source ID: | NCT01289119
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| Associated Drug: |
Alogliptin
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| Title: |
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01289119/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Alogliptin|DRUG: Placebo to alogliptin|DRUG: Metformin|DRUG: Pioglitazone
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| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), 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., Baseline and Week 16. | Secondary: Change From Baseline in HbA1c Over Time, The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. 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., Baseline and Weeks 4, 8 and 12.|Change From Baseline in Fasting Plasma Glucose Over Time, The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy., Baseline and Weeks 4, 8, 12 and 16.|Percentage of Participants With Marked Hyperglycemia, Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L)., Randomization to Week 16.|Change From Baseline in Body Weight, The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy., Baseline and Weeks 8 and 16.|Percentage of Participants With HbA1c ≤6.5% at Week 16, Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16., Week 16|Percentage of Participants With HbA1c ≤7.0% at Week 16, Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16., Week 16|Percentage of Participants With HbA1c ≤7.5% at Week 16, Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16., Week 16|Percentage of Participants With a Decrease in HbA1c ≥ 0.5%, Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16., Baseline and Week 16|Percentage of Participants With a Decrease in HbA1c ≥1.0%, Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16., Baseline and Week 16|Percentage of Participants With a Decrease in HbA1c ≥1.5%, Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16., Baseline and Week 16.|Percentage of Participants With a Decrease in HbA1c ≥2.0%, Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16., Baseline and Week 16.
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| Sponsor/Collaborators: |
Sponsor: Takeda
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
506
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2010-12
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| Completion Date: |
2011-12
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| Results First Posted: |
2013-03-22
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| Last Update Posted: |
2013-03-22
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| Locations: |
Beijing, Beijing, China|Fuzhou, Fujian, China|Xiamen, Fujian, China|Guangzhou, Guangdong, China|Haikou, Hainan, China|Ha'erbin, 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, China|Xi'an, Shanxi, China|Tianjin, Tianjin, China|Kunming, Yunnan, China|Hangzhou, Zhejiang, China|Hong Kong, Hong Kong|Taipei County, Taiwan
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| URL: |
https://clinicaltrials.gov/show/NCT01289119
|
