Clinical trial NCT01665352: A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in HbA1c (%) as compared to placebo
timeFrame: Day 1 to Day 84
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose (mg/dL)
timeFrame: Day 1, Day 14, Day 28, Day 56 and Day 84
measure: Subject achievement of HbA1c <7%
timeFrame: Day 84
measure: Change from baseline in body weight
timeFrame: Day 1, Day 14, Day 28, Day 56 and Day 84
measure: Subject achievement of body weight loss ≥ 2%
timeFrame: Day 1 and Day 84
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Site 18
state: California
city: Los Angeles
country: United States
facility: Site 1
state: California
city: Denver
country: United States
facility: Site 13
state: Colorado
city: Coral Gables
country: United States
facility: Site 4
state: Florida
city: Port Orange
country: United States
facility: Site 5
state: Florida
city: Honolulu
country: United States
facility: Site 3
state: Hawaii
city: Indianapolis
country: United States
facility: Site 17
state: Indiana
city: Louisville
country: United States
facility: Site 7
state: Kentucky
city: Auburn
country: United States
facility: Site 8
state: Maine
city: Las Vegas
country: United States
facility: Site 9
state: Nevada
city: Trenton
country: United States
facility: Site 26
state: New Jersey
city: Rochester
country: United States
facility: Site 12
state: New York
city: Cincinnati
country: United States
facility: Site 14
state: Ohio
city: Mount Pleasant
country: United States
facility: Site 6
state: South Carolina
city: Dallas
country: United States
facility: Site 16
state: Texas
city: Houston
country: United States
facility: Site 10
state: Texas
city: Houston
country: United States
facility: Site 2
state: Texas
city: Katy
country: United States
facility: Site 11
state: Texas
city: Richmond
country: United States
facility: Site 15
state: Virginia
Study officials:
affiliation: TransTech Pharma, Inc.
name: Stephanie Gustavson, Ph.D.
role: STUDY_DIRECTOR
References: