Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

NCT ID: NCT00929539

Last Updated: 2013-02-04

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

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

Detailed Description

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Conditions

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Type II Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1 JTT-130

Group Type EXPERIMENTAL

JTT-130

Intervention Type DRUG

Tablets

Dose 2 JTT-130

Group Type EXPERIMENTAL

JTT-130

Intervention Type DRUG

Tablets

Dose 3 JTT-130

Group Type EXPERIMENTAL

JTT-130

Intervention Type DRUG

Tablets

Placebo

Group Type PLACEBO_COMPARATOR

JTT-130 Placebo

Intervention Type DRUG

Tablets

Interventions

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JTT-130

Tablets

Intervention Type DRUG

JTT-130 Placebo

Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Have type 2 diabetes;
2. Body mass index (BMI) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2;
3. Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion Criteria

1. Females who are pregnant or breast-feeding
2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet medication restriction criteria, as described in the protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akros Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

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Muscle Shoals, Alabama, United States

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Scottsboro, Alabama, United States

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Tucson, Arizona, United States

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Encino, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Spring Valley, California, United States

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Valley Village, California, United States

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Walnut Creek, California, United States

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Waterbury, Connecticut, United States

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Delray Beach, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Sandy Springs, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Erlanger, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Paducah, Kentucky, United States

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New Hyde Park, New York, United States

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Greensboro, North Carolina, United States

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Morehead City, North Carolina, United States

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Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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Marion, Ohio, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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North Charleston, South Carolina, United States

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Bristol, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Manassas, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Olympia, Washington, United States

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Oregon, Wisconsin, United States

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Beroun, , Czechia

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Brno, , Czechia

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Ostrava, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Velké Hoštice, , Czechia

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Sátoraljaújhely, , Hungary

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Szikszó, , Hungary

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Eindhoven, , Netherlands

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Groningen, , Netherlands

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Arkhangelsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Countries

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United States Czechia Hungary Netherlands Russia

Other Identifiers

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AT130-G-08-006

Identifier Type: -

Identifier Source: org_study_id

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