A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
- Registration Number
- NCT01665352
- Lead Sponsor
- vTv Therapeutics
- Brief Summary
The purpose of this study is to compare the safety and effect of TTP054 versus placebo on glucose control in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus
- 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 or evidence of significant diabetic complications
- History of heart attack, stroke or congestive heart failure
- Severe, uncontrolled hypertension
- Frequent hypoglycemia
- Women of child-bearing potential
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TTP054 400 mg TTP054 - Placebo Placebo - TTP054 200 mg TTP054 - TTP054 800 mg TTP054 -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c (%) as compared to placebo Day 1 to Day 84
- Secondary Outcome Measures
Name Time Method Subject achievement of body weight loss ≥ 2% Day 1 and Day 84 Change from baseline in fasting plasma glucose (mg/dL) Day 1, Day 14, Day 28, Day 56 and Day 84 Subject achievement of HbA1c <7% Day 84 Change from baseline in body weight Day 1, Day 14, Day 28, Day 56 and Day 84
Trial Locations
- Locations (19)
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
Scroll for more (9 remaining)Site 18🇺🇸Chula Vista, California, United States