Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

January 31, 2013 updated by: Akros Pharma Inc.

A Phase II, Randomized, Double-Blind, Placebo-controlled, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients

The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Phoenix, Arizona, United States
      • Tempe, Arizona, United States
    • California
      • Chino, California, United States
      • Greenbrae, California, United States
      • Huntington Park, California, United States
      • Los Angeles, California, United States
      • Paramount, California, United States
      • Sacramento, California, United States
      • Walnut Creek, California, United States
      • West Covina, California, United States
    • Florida
      • Deland, Florida, United States
      • Hialeah, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Port Orange, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Addison, Illinois, United States
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maryland
      • Oxon Hill, Maryland, United States
    • Massachusetts
      • New Bedford, Massachusetts, United States
    • Montana
      • Great Falls, Montana, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Morehead City, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Marion, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Lansdale, Pennsylvania, United States
    • Tennessee
      • Bristol, Tennessee, United States
    • Texas
      • Carrollton, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Katy, Texas, United States
      • San Antonio, Texas, United States
      • Sugar Land, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Have type 2 diabetes;
  2. Body mass index (BMI) of ≤ 45.0 kg/m2;
  3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion Criteria:

  1. Females who are pregnant or breast-feeding;
  2. Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
  3. Acute coronary syndrome or uncontrolled hypertension;
  4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: JTT-654 Placebo
Tablets
Experimental: Dose 1 JTT-654
Drug: JTT-654
Tablets
Experimental: Dose 2 JTT-654
Drug: JTT-654
Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Fasting Plasma Glucose (FPG) levels
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in glycosylated hemoglobin (HbA1c) levels
Time Frame: 3 months
3 months
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
Time Frame: 3 months
3 months
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akros Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT654-U-09-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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