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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: TTP054; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Site 18
    • Los Angeles, California, United States, 90057
      • Site 1
  • Colorado
    • Denver, Colorado, United States, 80220
      • Site 13
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Site 4
    • Port Orange, Florida, United States, 32127
      • Site 5
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Site 3
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Site 17
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Site 7
  • Maine
    • Auburn, Maine, United States, 04210
      • Site 8
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • Site 9
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Site 26
  • New York
    • Rochester, New York, United States, 14609
      • Site 12
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Site 14
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Site 6
  • Texas
    • Dallas, Texas, United States, 75230
      • Site 16
    • Houston, Texas, United States, 77072
      • Site 10
    • Houston, Texas, United States, 77074
      • Site 2
    • Katy, Texas, United States, 77450
      • Site 11
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Site 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered orally once daily for 12 weeks.
Experimental: TTP054 400 mg	Drug: TTP054; Administered orally once daily for 12 weeks.
Experimental: TTP054 200 mg	Drug: TTP054; Administered orally once daily for 12 weeks.
Experimental: TTP054 800 mg	Drug: TTP054; Administered orally once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c (%) as compared to placebo	Day 1 to Day 84

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Subject achievement of body weight loss ≥ 2%	Day 1 and Day 84

Collaborators and Investigators

• Sponsor: vTv Therapeutics
• Investigators: Study Director: Stephanie Gustavson, Ph.D., TransTech Pharma, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TTP054-201