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

NCT ID: NCT01665352

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TTP054 400 mg

Group Type EXPERIMENTAL

TTP054

Intervention Type DRUG

Administered orally once daily for 12 weeks.

TTP054 200 mg

Group Type EXPERIMENTAL

TTP054

Intervention Type DRUG

Administered orally once daily for 12 weeks.

TTP054 800 mg

Group Type EXPERIMENTAL

TTP054

Intervention Type DRUG

Administered orally once daily for 12 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally once daily for 12 weeks.

Interventions

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TTP054

Administered orally once daily for 12 weeks.

Intervention Type DRUG

Placebo

Administered orally once daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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vTv Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Gustavson, Ph.D.

Role: STUDY_DIRECTOR

TransTech Pharma, Inc.

Locations

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Site 18

Chula Vista, California, United States

Site Status

Site 1

Los Angeles, California, United States

Site Status

Site 13

Denver, Colorado, United States

Site Status

Site 4

Coral Gables, Florida, United States

Site Status

Site 5

Port Orange, Florida, United States

Site Status

Site 3

Honolulu, Hawaii, United States

Site Status

Site 17

Indianapolis, Indiana, United States

Site Status

Site 7

Louisville, Kentucky, United States

Site Status

Site 8

Auburn, Maine, United States

Site Status

Site 9

Las Vegas, Nevada, United States

Site Status

Site 26

Trenton, New Jersey, United States

Site Status

Site 12

Rochester, New York, United States

Site Status

Site 14

Cincinnati, Ohio, United States

Site Status

Site 6

Mt. Pleasant, South Carolina, United States

Site Status

Site 16

Dallas, Texas, United States

Site Status

Site 10

Houston, Texas, United States

Site Status

Site 2

Houston, Texas, United States

Site Status

Site 11

Katy, Texas, United States

Site Status

Site 15

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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TTP054-201

Identifier Type: -

Identifier Source: org_study_id

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