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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00997152
First received: October 14, 2009
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Type II Diabetes Mellitus
 Drug: JTT-654
Drug: JTT-654 Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 JTT-654 Drug: JTT-654
Tablets
Experimental: Dose 2 JTT-654 Drug: JTT-654
Tablets
Placebo Comparator: Placebo Drug: JTT-654 Placebo
Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997152

  Hide Study Locations
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.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00997152     History of Changes
Other Study ID Numbers: AT654-U-09-004
Study First Received: October 14, 2009
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Akros Pharma Inc.:
Diabetes

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

ClinicalTrials.gov processed this record on May 21, 2013