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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics
ClinicalTrials.gov Identifier:
NCT01665352
First received: August 13, 2012
Last updated: February 9, 2017
Last verified: February 2017
August 13, 2012
February 9, 2017
August 2012
May 2013   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c (%) as compared to placebo [ Time Frame: Day 1 to Day 84 ]
Same as current
Complete list of historical versions of study NCT01665352 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose (mg/dL) [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ]
  • Subject achievement of HbA1c <7% [ Time Frame: Day 84 ]
  • Change from baseline in body weight [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ]
  • Subject achievement of body weight loss ≥ 2% [ Time Frame: Day 1 and Day 84 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: TTP054
    Administered orally once daily for 12 weeks.
  • Drug: Placebo
    Administered orally once daily for 12 weeks.
  • Experimental: TTP054 400 mg
    Intervention: Drug: TTP054
  • Experimental: TTP054 200 mg
    Intervention: Drug: TTP054
  • Experimental: TTP054 800 mg
    Intervention: Drug: TTP054
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01665352
TTP054-201
No
Not Provided
Not Provided
vTv Therapeutics
vTv Therapeutics
Not Provided
Study Director: Stephanie Gustavson, Ph.D. TransTech Pharma, Inc.
vTv Therapeutics
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP