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: TTP054; 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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2015-04-14
• Disposition First Submitted QC: 2015-04-14
• Disposition First Posted: 2015-05-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

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 5; 🇺🇸 Port Orange, Florida, United States

Site 13; 🇺🇸 Denver, Colorado, United States

Site 1; 🇺🇸 Los Angeles, California, United States

Site 18; 🇺🇸 Chula Vista, California, United States

Site 11; 🇺🇸 Katy, Texas, United States

Site 4; 🇺🇸 Coral Gables, Florida, United States

Site 3; 🇺🇸 Honolulu, Hawaii, United States

Site 7; 🇺🇸 Louisville, Kentucky, United States

Site 8; 🇺🇸 Auburn, Maine, United States

Site 14; 🇺🇸 Cincinnati, Ohio, United States

Site 6; 🇺🇸 Mount Pleasant, South Carolina, United States

Site 9; 🇺🇸 Las Vegas, Nevada, United States

Site 12; 🇺🇸 Rochester, New York, United States

Site 16; 🇺🇸 Dallas, Texas, United States

Site 26; 🇺🇸 Trenton, New Jersey, United States

Site 2; 🇺🇸 Houston, Texas, United States

Site 10; 🇺🇸 Houston, Texas, United States

Site 15; 🇺🇸 Richmond, Virginia, United States

Site 17; 🇺🇸 Indianapolis, Indiana, United States