Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes Mellitus
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate Treatment With SYR-472 in Subjects With Type 2 Diabetes
2 other identifiers
interventional
386
2 countries
112
Brief Summary
The purpose of this study is to determine the efficacy and safety of SYR-472, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus
Started Mar 2007
Shorter than P25 for phase_2 diabetes-mellitus
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedJune 22, 2016
June 1, 2016
1 year
September 24, 2008
June 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in glycosylated hemoglobin
Week 12 or Final Visit
Secondary Outcomes (15)
Change from baseline in glycosylated hemoglobin
Weeks 4, 8 and 12 or Final Visit.
Change from baseline in fasting plasma glucose
Weeks 1, 2, 4, 8, and 12 or Final Visit
Change from baseline in 1,5-Anhydroglucitol
Weeks 2, 4, 8, and 12 or Final Visit.
Change from baseline in Proinsulin
Weeks 4, 8, and 12 or Final Visit.
Change from baseline in Insulin
Weeks 4, 8, and 12 or Final Visit.
- +10 more secondary outcomes
Study Arms (6)
SYR-472 3.125 mg QD
EXPERIMENTAL(with lifestyle modification and/or metformin stable dose therapy)
SYR-472 12.5 mg QD
EXPERIMENTAL(with lifestyle modification and/or metformin stable dose therapy)
SYR-472 50 mg QD
EXPERIMENTAL(with lifestyle modification and/or metformin stable dose therapy)
SYR-472 100 mg QD
EXPERIMENTAL(with lifestyle modification and/or metformin stable dose therapy)
Placebo QD
PLACEBO COMPARATOR(with lifestyle modification and/or metformin stable dose therapy)
Sitagliptin 100 mg QD
ACTIVE COMPARATOR(with lifestyle modification and/or metformin stable dose therapy)
Interventions
SYR-472 3.125 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
SYR-472 placebo-matching tablets, orally, once daily with lifestyle modification and/or metformin therapy for up to 12 weeks.
Sitagliptin 100 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.
Eligibility Criteria
You may qualify if:
- Had a historical diagnosis of type 2 diabetes mellitus.
- Had undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
- If receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run in/Stabilization Period as determined by subject diary and investigator assessment.
- Had received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening.
- The subject has an glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
- Had a body mass index between 23 and 45 kg/m2.
- A C-peptide concentration is greater than or equal to 0.8 ng/mL (greater than or equal to 0.26 nmol/L).
- A fasting plasma glucose concentration is less than 275 mg/dL (less than 15.27 mmol/L) at Screening and at the Week -1 Visit.
- If the subject regularly uses other non-excluded medications, he or she must be on a stable dose for at least the 4 weeks prior to Screening.
- The subject has a systolic blood pressure reading of less than 160 mm Hg and a diastolic pressure reading of less than 100 mm Hg.
- The subject has a hemoglobin value greater than or equal to 12 g/dL (greater than or equal to 120 g/L) for men and greater than or equal to 10 g/dL (greater than or equal to 100 g/L) for women.
- Had an alanine aminotransferase level is less than or equal to 3 times the upper limit of normal.
- A male subject has a serum creatinine value of less than 1.5 mg/dL (less than 133 μmol/L); a female subject has a serum creatinine value of less than 1.4 mg/dL (less than 124 μmol/L).
- Had a urine albumin/creatinine ratio of less than 1000 μg/mg at Screening.
- Had a thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
- +3 more criteria
You may not qualify if:
- Was being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
- Had a 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.
- Had a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- Had a history of treated diabetic gastric paresis.
- Had a New York Heart Association class III or IV heart failure regardless of therapy.
- Had a history of coronary angioplasty, coronary stent placement or coronary bypass surgery, myocardial infarction, or stroke within the 6 months prior to Screening.
- Had a history of hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- Had a history of infection with human immunodeficiency virus.
- Had a history of a psychiatric disorder that in the investigator's opinion will affect the subject's ability to participate in the study.
- Had a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within the 2 years prior to Screening.
- Was required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Ingested or received systemically injected glucocorticoids within the 3 months prior to randomization.
- Used prescription or over-the-counter weight-loss drugs within the 3 months prior to randomization.
- Received any investigational drug within the 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
- Had received previous treatment in an investigational study of SYR-472.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (112)
Unknown Facility
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Anderson, Arkansas, United States
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Little Rock, Arkansas, United States
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Pine Bluff, Arkansas, United States
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Carmichael, California, United States
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Chino, 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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Los Gatos, California, United States
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Orange, California, United States
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Pico Rivera, California, United States
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Rolling Hills Estates, California, United States
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Roseville, California, United States
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Rowland Heights, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Arvada, Colorado, United States
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Colorado Springs, Colorado, United States
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Highlands Ranch, Colorado, United States
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Avon, Connecticut, United States
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Rocky Hill, Connecticut, United States
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Newark, Delaware, United States
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Aventura, Florida, United States
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Edgewater, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Zanesville, Florida, United States
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Atlanta, Georgia, United States
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Roswell, Georgia, United States
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Waycross, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Avon, Indiana, United States
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Fort Wayne, Indiana, United States
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Des Moines, Iowa, United States
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Waterloo, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Crestview, Kentucky, United States
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Oxon Hill, Maryland, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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West Caldwell, New Jersey, United States
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Wildwood Crest, New Jersey, United States
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Albuquerque, New Mexico, United States
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East Islip, New York, United States
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Lewiston, New York, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Wantagh, New York, United States
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Hickory, North Carolina, United States
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Statesville, North Carolina, United States
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Tabor City, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Mason, Ohio, United States
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Wadsworth, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Bensalem, Pennsylvania, United States
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Connellsville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Shippensburg, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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North Myrtle Beach, South Carolina, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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New Tazewell, Tennessee, United States
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Carrolton, Texas, United States
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Dallas, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Spanish Fork, Utah, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Spokane, Washington, United States
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Zapopan, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Puebla City, Puebla, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Nezahualcóyotl, Mexico
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Veracruz, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP Biological Sciences
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
September 24, 2008
First Posted
September 26, 2008
Study Start
March 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
June 22, 2016
Record last verified: 2016-06