A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
70
1 country
21
Brief Summary
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2003
Shorter than P25 for phase_2
21 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
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedOctober 19, 2022
October 1, 2022
August 4, 2009
October 17, 2022
Conditions
Study Arms (3)
T0903131 Besylate
EXPERIMENTAL1.0 mg
T0903131 Besylate (higher dose)
EXPERIMENTAL10.0 mg
Placebo
PLACEBO COMPARATOROnce daily, oral
Interventions
Once daily, oral
Eligibility Criteria
You may qualify if:
- Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
- Fasting Plasma Glucose between 126 and 240 mg/dL
- Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
- Fasting C-peptide \> 0.8 ng/mL
You may not qualify if:
- Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
- Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
- BMI \> 42 kg/m2
- Presence of any diabetic complications requiring chronic therapy
- Presence or history of any form of hepatic disease
- Serum creatinine \> 1.8 mg/dL
- History of cardiac arrhythmias or abnormal cardiac electrophysiology
- Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Whittier Diabetes Institute
La Jolla, California, United States
Charles R. Drew University
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
Lovelace Research Institute
Santa Ana, California, United States
University of Miami
Miami, Florida, United States
GFI Research Center
Evansville, Indiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Radiant Research
Edina, Minnesota, United States
Radiant Research
St Louis, Missouri, United States
St Louis Center for Clinical Research
St Louis, Missouri, United States
Kaleida Health Diabetes Center
Buffalo, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Radiant Research
Portland, Oregon, United States
Radiant Research
Anderson, South Carolina, United States
Baylor University Endocrine Center
Dallas, Texas, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, United States
Endocrine Associates of Dallas
Dallas, Texas, United States
Diabetes and Grandular Disease Clinic and Reseach Center
San Antonio, Texas, United States
Endocrine Research Specialists
Ogden, Utah, United States
Salem VA Medical Center
Salem, Virginia, United States
Related Publications (1)
Dunn FL, Higgins LS, Fredrickson J, DePaoli AM; INT131-004 study group. Selective modulation of PPARgamma activity can lower plasma glucose without typical thiazolidinedione side-effects in patients with Type 2 diabetes. J Diabetes Complications. 2011 May-Jun;25(3):151-8. doi: 10.1016/j.jdiacomp.2010.06.006. Epub 2010 Aug 23.
PMID: 20739195DERIVED
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
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
December 1, 2003
Study Completion
June 1, 2004
Last Updated
October 19, 2022
Record last verified: 2022-10