A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
NCT ID: NCT02653599
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
174 participants
INTERVENTIONAL
2015-12-31
2017-01-31
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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TTP273 300 mg daily (150 mg BID)
Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks
TTP273
TTP273 150 mg daily
Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks
TTP273
Placebo
Placebo
Two matching placebo tablets administered orally twice daily for 12 weeks
Placebo
Interventions
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TTP273
Placebo
Eligibility Criteria
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Inclusion Criteria
* On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months prior to screening.
* Males. Females of non-childbearing potential.
* Generally stable health without a history of major surgery or significant injuries within the last year and without an active infection.
Exclusion Criteria
* Participation in a clinical trial and receipt of an investigational product within 30 days.
* Participation in any formal weight loss program, or fluctuation of \> 5% in body weight, or having received medications approved for weight loss within 3 months prior to screening or contemplating such therapy during the trial.
* Previous surgical treatment of obesity.
* Have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice administered by someone other than the patient within 6 months prior to screening.
* Use of other diabetic agents except metformin within 3 months prior to Screening.
* History of pancreatitis.
* Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to screening.
* History of hemolytic anemia, chronic transfusion requirement or other condition rendering HbA1c results unreliable.
* History of MEN-2 or family history of medullary thyroid cancer.
* History or presence of clinically significant disease (other than Type 2 diabetes mellitus).
18 Years
75 Years
ALL
No
Sponsors
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vTv Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Freeman, Ph.D.
Role: STUDY_CHAIR
vTv Therapeutics LLC
Locations
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Costa Mesa, California, United States
Encino, California, United States
Huntington Park, California, United States
Los Angeles, California, United States
Oakland, California, United States
Sacramento, California, United States
DeLand, Florida, United States
Miami Lakes, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Evanston, Illinois, United States
Flint, Michigan, United States
Omaha, Nebraska, United States
The Bronx, New York, United States
Greensboro, North Carolina, United States
High Point, North Carolina, United States
Morehead City, North Carolina, United States
Cincinnati, Ohio, United States
Norman, Oklahoma, United States
Norman, Oklahoma, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Hurst, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Richland, Washington, United States
Countries
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Other Identifiers
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TTP273-201
Identifier Type: -
Identifier Source: org_study_id
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