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A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
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
GroupInterventionDescription
TTP054 400 mgTTP054-
PlaceboPlacebo-
TTP054 200 mgTTP054-
TTP054 800 mgTTP054-
Primary Outcome Measures
NameTimeMethod
Change from baseline in HbA1c (%) as compared to placeboDay 1 to Day 84
Secondary Outcome Measures
NameTimeMethod
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 weightDay 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

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