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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929539
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : February 4, 2013
Information provided by (Responsible Party):
Akros Pharma Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: JTT-130 Drug: JTT-130 Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose 1 JTT-130 Drug: JTT-130

Experimental: Dose 2 JTT-130 Drug: JTT-130

Experimental: Dose 3 JTT-130 Drug: JTT-130

Placebo Comparator: Placebo Drug: JTT-130 Placebo

Primary Outcome Measures :
  1. Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: End of Study ]

Secondary Outcome Measures :
  1. Safety and tolerability data [ Time Frame: End of Study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00929539

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
Muscle Shoals, Alabama, United States
Scottsboro, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Encino, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Valley Village, California, United States
Walnut Creek, California, United States
United States, Connecticut
Waterbury, Connecticut, United States
United States, Florida
Delray Beach, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
United States, Georgia
Sandy Springs, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kentucky
Erlanger, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Paducah, Kentucky, United States
United States, New York
New Hyde Park, New York, United States
United States, North Carolina
Greensboro, North Carolina, United States
Morehead City, North Carolina, United States
Statesville, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Marion, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
Portland, Oregon, United States
United States, South Carolina
Charleston, South Carolina, United States
Greer, South Carolina, United States
North Charleston, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
United States, Texas
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Manassas, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Bellevue, Washington, United States
Olympia, Washington, United States
United States, Wisconsin
Oregon, Wisconsin, United States
Czech Republic
Beroun, Czech Republic
Brno, Czech Republic
Ostrava, Czech Republic
Pardubice, Czech Republic
Prague, Czech Republic
Velke Hostice, Czech Republic
Satoraljaujhely, Hungary
Szikszo, Hungary
Eindhoven, Netherlands
Groningen, Netherlands
Russian Federation
Arkhangelsk, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorod, Russian Federation
St. Petersburg, Russian Federation
Sponsors and Collaborators
Akros Pharma Inc.

Responsible Party: Akros Pharma Inc. Identifier: NCT00929539     History of Changes
Other Study ID Numbers: AT130-G-08-006
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013

Keywords provided by Akros Pharma Inc.:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases