Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
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
1 other identifier
interventional
496
5 countries
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Shorter than P25 for phase_2
62 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
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 4, 2013
January 1, 2013
11 months
June 26, 2009
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in glycosylated hemoglobin (HbA1c) levels
End of Study
Secondary Outcomes (1)
Safety and tolerability data
End of Study
Study Arms (4)
Dose 1 JTT-130
EXPERIMENTALDose 2 JTT-130
EXPERIMENTALDose 3 JTT-130
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Have type 2 diabetes;
- Body mass index (BMI) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2;
- 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.
You may not qualify if:
- Females who are pregnant or breast-feeding
- Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet medication restriction criteria, as described in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Scottsboro, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Encino, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
Valley Village, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Waterbury, Connecticut, United States
Unknown Facility
Delray Beach, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Sandy Springs, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Erlanger, Kentucky, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Madisonville, Kentucky, United States
Unknown Facility
Paducah, Kentucky, United States
Unknown Facility
New Hyde Park, New York, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
Morehead City, North Carolina, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Marion, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Eugene, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
North Charleston, South Carolina, United States
Unknown Facility
Bristol, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Manassas, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Oregon, Wisconsin, United States
Unknown Facility
Beroun, Czechia
Unknown Facility
Brno, Czechia
Unknown Facility
Ostrava, Czechia
Unknown Facility
Pardubice, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Velké Hoštice, Czechia
Unknown Facility
Sátoraljaújhely, Hungary
Unknown Facility
Szikszó, Hungary
Unknown Facility
Eindhoven, Netherlands
Unknown Facility
Groningen, Netherlands
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Nizhny Novgorod, Russia
Unknown Facility
Saint Petersburg, Russia
MeSH Terms
Conditions
Interventions
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
June 26, 2009
First Posted
June 29, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
February 4, 2013
Record last verified: 2013-01