Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
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
1 other identifier
interventional
152
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 4, 2013
January 1, 2013
6 months
October 14, 2009
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fasting Plasma Glucose (FPG) levels
3 months
Secondary Outcomes (3)
Change in glycosylated hemoglobin (HbA1c) levels
3 months
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
3 months
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
3 months
Study Arms (3)
Dose 1 JTT-654
EXPERIMENTALDose 2 JTT-654
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Have type 2 diabetes;
- Body mass index (BMI) of ≤ 45.0 kg/m2;
- Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
You may not qualify if:
- Females who are pregnant or breast-feeding;
- 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;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Chandler, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Chino, California, United States
Unknown Facility
Greenbrae, California, United States
Unknown Facility
Huntington Park, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Paramount, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
West Covina, California, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Addison, Illinois, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Oxon Hill, Maryland, United States
Unknown Facility
New Bedford, Massachusetts, United States
Unknown Facility
Great Falls, Montana, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Morehead City, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Marion, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Lansdale, Pennsylvania, United States
Unknown Facility
Bristol, Tennessee, United States
Unknown Facility
Carrollton, Texas, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Katy, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Sugar Land, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 19, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
February 4, 2013
Record last verified: 2013-01