A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
NCT ID: NCT01665352
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
186 participants
INTERVENTIONAL
2012-08-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TTP054 400 mg
TTP054
Administered orally once daily for 12 weeks.
TTP054 200 mg
TTP054
Administered orally once daily for 12 weeks.
TTP054 800 mg
TTP054
Administered orally once daily for 12 weeks.
Placebo
Placebo
Administered orally once daily for 12 weeks.
Interventions
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TTP054
Administered orally once daily for 12 weeks.
Placebo
Administered orally once daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* On a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (OAD) agent
* HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5%
Exclusion Criteria
* History of heart attack, stroke or congestive heart failure
* Severe, uncontrolled hypertension
* Frequent hypoglycemia
* Women of child-bearing potential
18 Years
70 Years
ALL
No
Sponsors
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vTv Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Stephanie Gustavson, Ph.D.
Role: STUDY_DIRECTOR
TransTech Pharma, Inc.
Locations
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Site 18
Chula Vista, California, United States
Site 1
Los Angeles, California, United States
Site 13
Denver, Colorado, United States
Site 4
Coral Gables, Florida, United States
Site 5
Port Orange, Florida, United States
Site 3
Honolulu, Hawaii, United States
Site 17
Indianapolis, Indiana, United States
Site 7
Louisville, Kentucky, United States
Site 8
Auburn, Maine, United States
Site 9
Las Vegas, Nevada, United States
Site 26
Trenton, New Jersey, United States
Site 12
Rochester, New York, United States
Site 14
Cincinnati, Ohio, United States
Site 6
Mt. Pleasant, South Carolina, United States
Site 16
Dallas, Texas, United States
Site 10
Houston, Texas, United States
Site 2
Houston, Texas, United States
Site 11
Katy, Texas, United States
Site 15
Richmond, Virginia, United States
Countries
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Other Identifiers
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TTP054-201
Identifier Type: -
Identifier Source: org_study_id
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