Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes
3 other identifiers
interventional
441
11 countries
80
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus
Started Jun 2008
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
May 24, 2013
CompletedMay 24, 2013
May 1, 2013
2.2 years
June 27, 2008
February 17, 2013
May 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin at Week 52.
The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
Baseline and Week 52.
Secondary Outcomes (18)
Change From Baseline in Glycosylated Hemoglobin
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.
Incidence of Hypoglycemia
On occurrence (up to 52 weeks).
Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).
On Occurrence (up to 52 weeks).
Incidence of Hyperglycemic Rescue
On Occurrence (up to 52 weeks).
Change From Baseline in Fasting Plasma Glucose
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.
- +13 more secondary outcomes
Study Arms (2)
Alogliptin 25 mg QD
EXPERIMENTALGlipizide 5 mg QD
ACTIVE COMPARATORInterventions
Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
Eligibility Criteria
You may qualify if:
- Has a diagnosis of type 2 diabetes mellitus with either:
- Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
- Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.
You may not qualify if:
- Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
- Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
- Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
- Calculated creatinine clearance less than or equal to 50 mL/min.
- Thyroid-stimulating hormone level outside of the normal range.
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
- New York Heart Association Class III or IV heart failure regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with Human Immunodeficiency Virus.
- History of a psychiatric disorder that will affect the participant's ability to participate in the study.
- History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- History of alcohol or substance abuse within the 2 years prior to Screening.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (80)
Unknown Facility
Alexander City, Alabama, United States
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Foothill Ranch, California, United States
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Huntington Park, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Redlands, California, United States
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Prospect, Connecticut, United States
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Bradenton, Florida, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Ormond Beach, Florida, United States
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Winter Park, Florida, United States
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Roswell, Georgia, United States
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Aurora, Illinois, United States
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La Porte, Indiana, United States
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South Bend, Indiana, United States
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Salisbury, Maryland, United States
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Clarkston, Michigan, United States
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Omaha, Nebraska, United States
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Hamilton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Beachwood, Ohio, United States
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Westlake, Ohio, United States
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Zanesville, Ohio, United States
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Bensalem, Pennsylvania, United States
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Aiken, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Taylors, South Carolina, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Pasadena, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Budapest, Hungary
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Miskoic, Hungary
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Nyíregyháza, Hungary
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Karnāl, Haryana, India
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Bangalore, Karnataka, India
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Belagavi, Karnataka, India
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Mumbai, Maharashrta, India
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Ashkelon, Israel
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Haifa, Israel
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Holon, Israel
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Nahariya, Israel
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Rishon LeZiyyon, Israel
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Safed, Israel
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Aguascalientes, Aguascalientes, Mexico
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Saltillo, Coahuila, Mexico
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Durango, Durango, Mexico
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Pachuca, Hidalgo, Mexico
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Morelia, Michoacán, Mexico
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Monterrey, Nuevo León, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Nezahualcóyotl, Mexico
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Arequipa, Peru
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Lima, Peru
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Piura, Peru
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Gdansk, Poland
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Krakow, Poland
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Warsaw, Poland
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Baia Mare, Romania
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Brasov, Romania
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Bucharest, Romania
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Galati, Romania
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Satu Mare, Romania
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Arkhangelsk, Russia
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Irkutsk, Russia
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Smolensk, Russia
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Cape Town, South Africa
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Centurion, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
VP Biological Sciences
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
May 24, 2013
Results First Posted
May 24, 2013
Record last verified: 2013-05