Efficacy and Safety Study of JTT-654 in 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: NCT00997152
Recruitment Status : Terminated
First Posted : October 19, 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-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: JTT-654 Drug: JTT-654 Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 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, 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
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose 1 JTT-654 Drug: JTT-654

Experimental: Dose 2 JTT-654 Drug: JTT-654

Placebo Comparator: Placebo Drug: JTT-654 Placebo

Primary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) levels [ Time Frame: 3 months ]

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

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 ≤ 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.

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): NCT00997152

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
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
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
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Addison, Illinois, United States
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maryland
Oxon Hill, Maryland, United States
United States, Massachusetts
New Bedford, Massachusetts, United States
United States, Montana
Great Falls, Montana, United States
United States, North Carolina
Charlotte, North Carolina, United States
Morehead City, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Marion, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Lansdale, Pennsylvania, United States
United States, Tennessee
Bristol, Tennessee, United States
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
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Sponsors and Collaborators
Akros Pharma Inc.

Responsible Party: Akros Pharma Inc. Identifier: NCT00997152     History of Changes
Other Study ID Numbers: AT654-U-09-004
First Posted: October 19, 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