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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TTP054
Placebo
Sponsored by
vTv Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 18
  • Site 1
  • Site 13
  • Site 4
  • Site 5
  • Site 3
  • Site 17
  • Site 7
  • Site 8
  • Site 9
  • Site 26
  • Site 12
  • Site 14
  • Site 6
  • Site 16
  • Site 10
  • Site 2
  • Site 11
  • Site 15

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

TTP054 400 mg

TTP054 200 mg

TTP054 800 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c (%) as compared to placebo

Secondary Outcome Measures

Change from baseline in fasting plasma glucose (mg/dL)
Subject achievement of HbA1c <7%
Change from baseline in body weight
Subject achievement of body weight loss ≥ 2%

Full Information

First Posted
August 13, 2012
Last Updated
February 9, 2017
Sponsor
vTv Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01665352
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
vTv Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TTP054 400 mg
Arm Type
Experimental
Arm Title
TTP054 200 mg
Arm Type
Experimental
Arm Title
TTP054 800 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TTP054
Intervention Description
Administered orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c (%) as compared to placebo
Time Frame
Day 1 to Day 84
Secondary Outcome Measure Information:
Title
Change from baseline in fasting plasma glucose (mg/dL)
Time Frame
Day 1, Day 14, Day 28, Day 56 and Day 84
Title
Subject achievement of HbA1c <7%
Time Frame
Day 84
Title
Change from baseline in body weight
Time Frame
Day 1, Day 14, Day 28, Day 56 and Day 84
Title
Subject achievement of body weight loss ≥ 2%
Time Frame
Day 1 and Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Gustavson, Ph.D.
Organizational Affiliation
TransTech Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 18
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Site 1
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Site 13
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Site 4
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site 5
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Site 3
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Site 17
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Site 7
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Site 8
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Site 9
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Site 26
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Site 12
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Site 14
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site 6
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site 16
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Site 10
City
Houston
State/Province
Texas
ZIP/Postal Code
77072
Country
United States
Facility Name
Site 2
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Site 11
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Site 15
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

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

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