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

NCT01665352 | Completed Phase 2

• 1 other identifier: TTP054-201
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 19

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  Day 1 to Day 84

Secondary Outcomes (4)

• 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

Study Arms (4)

TTP054 400 mg

EXPERIMENTAL

Drug: TTP054

TTP054 200 mg

EXPERIMENTAL

Drug: TTP054

TTP054 800 mg

EXPERIMENTAL

Drug: TTP054

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TTP054 DRUG

Administered orally once daily for 12 weeks.

TTP054 200 mg; TTP054 400 mg; TTP054 800 mg

Placebo DRUG

Administered orally once daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• vTv Therapeutics: lead

Study Sites (19)

Site 18

Chula Vista, California, 91911, United States

Location

Site 1

Los Angeles, California, 90057, United States

Location

Site 13

Denver, Colorado, 80220, United States

Location

Site 4

Coral Gables, Florida, 33134, United States

Location

Site 5

Port Orange, Florida, 32127, United States

Location

Site 3

Honolulu, Hawaii, 96814, United States

Location

Site 17

Indianapolis, Indiana, 46254, United States

Location

Site 7

Louisville, Kentucky, 40213, United States

Location

Site 8

Auburn, Maine, 04210, United States

Location

Site 9

Las Vegas, Nevada, 89101, United States

Location

Site 26

Trenton, New Jersey, 08611, United States

Location

Site 12

Rochester, New York, 14609, United States

Location

Site 14

Cincinnati, Ohio, 45219, United States

Location

Site 6

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 16

Dallas, Texas, 75230, United States

Location

Site 10

Houston, Texas, 77072, United States

Location

Site 2

Houston, Texas, 77074, United States

Location

Site 11

Katy, Texas, 77450, United States

Location

Site 15

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephanie Gustavson, Ph.D.

  TransTech Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (19)