| Trial ID: | L4841 |
| Source ID: | NCT00286455
|
| Associated Drug: |
Alogliptin
|
| Title: |
Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00286455/results
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Alogliptin|DRUG: Alogliptin|DRUG: Placebo
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| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline., Baseline and Week 26. | Secondary: Change From Baseline in Glycosylated Hemoglobin (Week 4)., The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline., Baseline and Week 4.|Change From Baseline in Glycosylated Hemoglobin (Week 8)., The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline., Baseline and Week 8.|Change From Baseline in Glycosylated Hemoglobin (Week 12)., The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline., Baseline and Week 12.|Change From Baseline in Glycosylated Hemoglobin (Week 16)., The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline., Baseline and Week 16.|Change From Baseline in Glycosylated Hemoglobin (Week 20)., The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline., Baseline and Week 20.|Change From Baseline in Fasting Plasma Glucose (Week 1)., The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline., Baseline and Week 1.|Change From Baseline in Fasting Plasma Glucose (Week 2)., The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline., Baseline and Week 2.|Change From Baseline in Fasting Plasma Glucose (Week 4)., The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline., Baseline and Week 4.|Change From Baseline in Fasting Plasma Glucose (Week 8)., The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting Plasma Glucose (Week 12)., The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline., Baseline and Week 12.|Change From Baseline in Fasting Plasma Glucose (Week 16)., The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline., Baseline and Week 16.|Change From Baseline in Fasting Plasma Glucose (Week 20)., The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline., Baseline and Week 20.|Change From Baseline in Fasting Plasma Glucose (Week 26)., The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline., Baseline and Week 26.|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL)., The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study., 26 Weeks.|Number of Participants Requiring Rescue., The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study., 26 Weeks.|Change From Baseline in Fasting Proinsulin (Week 4)., The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline., Baseline and Week 4.|Change From Baseline in Fasting Proinsulin (Week 8)., The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting Proinsulin (Week 12)., The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline., Baseline and Week 12.|Change From Baseline in Fasting Proinsulin (Week 16)., The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline., Baseline and Week 16.|Change From Baseline in Fasting Proinsulin (Week 20)., The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline., Baseline and Week 20.|Change From Baseline in Fasting Proinsulin (Week 26)., The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline., Baseline and Week 26.|Change From Baseline in Insulin (Week 4)., The change between the value of insulin collected at week 4 and insulin collected at baseline., Baseline and Week 4.|Change From Baseline in Insulin (Week 8)., The change between the value of insulin collected at week 8 and insulin collected at baseline., Baseline and Week 8.|Change From Baseline in Insulin (Week 12)., The change between the value of insulin collected at week 12 and insulin collected at baseline., Baseline and Week 12.|Change From Baseline in Insulin (Week 16)., The change between the value of insulin collected at week 16 and insulin collected at baseline., Baseline and Week 16.|Change From Baseline in Insulin (Week 20)., The change between the value of insulin collected at week 20 and insulin collected at baseline., Baseline and Week 20.|Change From Baseline in Insulin (Week 26)., The change between the value of insulin collected at week 26 and insulin collected at baseline., Baseline and Week 26.|Change From Baseline in Proinsulin/Insulin Ratio (Week 4)., The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline., Baseline and Week 4.|Change From Baseline in Proinsulin/Insulin Ratio (Week 8)., The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline., Baseline and Week 8.|Change From Baseline in Proinsulin/Insulin Ratio (Week 12)., The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline., Baseline and Week 12.|Change From Baseline in Proinsulin/Insulin Ratio (Week 16)., The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline., Baseline and Week 16.|Change From Baseline in Proinsulin/Insulin Ratio (Week 20)., The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline., Baseline and Week 20.|Change From Baseline in Proinsulin/Insulin Ratio (Week 26)., The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline., Baseline and Week 26.|Change From Baseline in C-peptide (Week 4)., The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline., Baseline and Week 4.|Change From Baseline in C-peptide (Week 8)., The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline., Baseline and Week 8.|Change From Baseline in C-peptide (Week 12)., The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline., Baseline and Week 12.|Change From Baseline in C-peptide (Week 16)., The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline., Baseline and Week 16.|Change From Baseline in C-peptide (Week 20)., The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline., Baseline and Week 20.|Change From Baseline in C-peptide (Week 26)., The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%., The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%., The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%., The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%., The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%., The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%., The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study., Baseline and Week 26.|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%., The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study., Baseline and Week 26.|Change From Baseline in Body Weight (Week 8)., The change between Body Weight measured at week 8 and Body Weight measured at baseline., Baseline and Week 8.|Change From Baseline in Body Weight (Week 12)., The change between Body Weight measured at week 12 and Body Weight measured at baseline., Baseline and Week 12.|Change From Baseline in Body Weight (Week 20)., The change between Body Weight measured at week 20 and Body Weight measured at baseline., Baseline and Week 20.|Change From Baseline in Body Weight (Week 26)., The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline., Baseline and Week 26.|Change From Baseline in Glucagon (Week 4)., The change between the value of glucagon collected at week 4 and glucagon collected at baseline., Baseline and Week 4.|Change From Baseline in Glucagon (Week 8)., The change between the value of glucagon collected at week 8 and glucagon collected at baseline., Baseline and Week 8.|Change From Baseline in Glucagon (Week 12)., The change between the value of glucagon collected at week 12 and glucagon collected at baseline., Baseline and Week 12.|Change From Baseline in Glucagon (Week 16)., The change between the value of glucagon collected at week 16 and glucagon collected at baseline., Baseline and Week 16.|Change From Baseline in Glucagon (Week 20)., The change between the value of glucagon collected at week 20 and glucagon collected at baseline., Baseline and Week 20.|Change From Baseline in Glucagon (Week 26)., The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline., Baseline and Week 26.
|
| Sponsor/Collaborators: |
Sponsor: Takeda
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
329
|
| 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: |
2006-02
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| Completion Date: |
2007-07
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| Results First Posted: |
2011-08-29
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| Last Update Posted: |
2012-02-03
|
| Locations: |
Birmingham, Alabama, United States|Peoria, Arizona, United States|Phoenix, Arizona, United States|Anaheim, California, United States|Artesia, California, United States|Fresno, California, United States|Lafayette, California, United States|Northridge, California, United States|Orange, California, United States|San Diego, California, United States|Walnut Creek, California, United States|Colorado Springs, Colorado, United States|Denver, Colorado, United States|Washington, District of Columbia, United States|Cocoa Beach, Florida, United States|Kissimmee, Florida, United States|Longwood, Florida, United States|Ocala, Florida, United States|Ocoee, Florida, United States|St. Cloud, Florida, United States|Honolulu, Hawaii, United States|Idaho Falls, Idaho, United States|Avon, Indiana, United States|Elkhart, Indiana, United States|Evansville, Indiana, United States|Baltimore, Maryland, United States|Sudbury, Massachusetts, United States|St. Louis, Missouri, United States|Omaha, Nebraska, United States|Berlin, New Jersey, United States|Burlington, North Carolina, United States|Morehead City, North Carolina, United States|Pinehurst, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Tulsa, Oklahoma, United States|Lansdale, Pennsylvania, United States|West Grove, Pennsylvania, United States|Charleston, South Carolina, United States|Columbia, South Carolina, United States|Simpsonville, South Carolina, United States|Bristol, Tennessee, United States|Cookeville, Tennessee, United States|Milan, Tennessee, United States|Corpus Christi, Texas, United States|Dallas, Texas, United States|San Antonio, Texas, United States|Temple, Texas, United States|Texarkana, Texas, United States|Burlington, Vermont, United States|Multiple Cities, Argentina|Multiple Cities, Australia|Multiple Cities, Brazil|Multiple Cities, Chile|Multiple Cities, Czech Republic|Multiple Cities, Dominican Republic|Multiple Cities, Germany|Multiple Cities, Guatemala|Multiple Cities, Hungary|Multiple Cities, India|Multiple Cities, Mexico|Multiple Cities, Netherlands|Multiple Cities, New Zealand|Multiple Cities, Peru|Multiple Cities, Poland|Multiple Cities, South Africa|Multiple Cities, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT00286455
|
