Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

July 25, 2013 updated by: Akros Pharma Inc.

A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Study Type

Interventional

Enrollment (Actual)

325

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
      • Dothan, Alabama, United States
      • Huntsville, Alabama, United States
      • Montgomery, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arizona
      • Glendale, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Artesia, California, United States
      • Beverly Hills, California, United States
      • Buena Park, California, United States
      • Chino, California, United States
      • Garden Grove, California, United States
      • Lincoln, California, United States
      • Lomita, California, United States
      • Los Angeles, California, United States
      • Newport Beach, California, United States
      • North Hollywood, California, United States
      • Paramount, California, United States
      • Sacramento, California, United States
      • Spring Valley, California, United States
      • Walnut Creek, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Cooper City, Florida, United States
      • Ft. Lauderdale, Florida, United States
      • Hialeah, Florida, United States
      • Kissimee, Florida, United States
      • Miami, Florida, United States
      • Miramar, Florida, United States
      • Ocala, Florida, United States
      • Orlando, Florida, United States
      • Ormond Beach, Florida, United States
      • Pembroke Pines, Florida, United States
      • Port Orange, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
      • Marietta, Georgia, United States
    • Idaho
      • Nampa, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Evanston, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Lake Charles, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Oxon Hill, Maryland, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
      • Mine Hill, New Jersey, United States
    • New York
      • Glen Falls, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Kettering, Ohio, United States
      • Marion, Ohio, United States
      • Munroe Falls, Ohio, United States
      • Wadsworth, Ohio, United States
    • Oklahoma
      • Norman, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Lansdale, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Greer, South Carolina, United States
    • Texas
      • Carrollton, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • Sugarland, Texas, United States
      • Tomball, Texas, United States
    • Utah
      • Murray, Utah, United States
      • Orem, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Burke, Virginia, United States
      • Manassas, Virginia, United States
      • Norfolk, Virginia, United States
      • Suffolk, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, 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:

  • Males and females with type 2 diabetes, 18-70 years of age at Visit 1
  • Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
  • Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
  • Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1

Exclusion Criteria:

  • Females who are pregnant or breast-feeding
  • Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
  • Acute coronary syndrome or uncontrolled hypertension
  • Does not meet all diet or previous/concomitant medication restriction criteria

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: JTT-851 Dose 1
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Drug: JTT-851
Drug: Placebo for comparator
EXPERIMENTAL: JTT-851 Dose 2
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Drug: JTT-851
Drug: Placebo for comparator
EXPERIMENTAL: JTT-851 Dose 3
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Drug: JTT-851
Drug: Placebo for comparator
ACTIVE_COMPARATOR: Glimepiride Dose 1
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
Drug: Glimepiride
Encapsulated Glimepiride tablets
Drug: Placebo for Active
PLACEBO_COMPARATOR: Placebo active & Placebo comparator
Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
Drug: Placebo for comparator
Drug: Placebo for Active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851
Time Frame: 12 weeks
To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo
Time Frame: 12 weeks
To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.
12 weeks
Effect on ancillary efficacy measures
Time Frame: 12 weeks
To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.
12 weeks
Pharmacokinetics of JTT-851 and its metabolites
Time Frame: 12 weeks
To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between dose and response of JTT-851
Time Frame: 12 weeks
To explore the relationship between the JTT-851 dose (exposure) and response
12 weeks

Collaborators and Investigators

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

Sponsor

Akros Pharma Inc.

Investigators

  • Study Chair: Hisashi Kodama, Ph.D., 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, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 25, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT851-U-12-002

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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