A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
NCT ID: NCT00952445
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2003-12-31
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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T0903131 Besylate
1.0 mg
T0903131 Besylate
Once daily, oral
T0903131 Besylate (higher dose)
10.0 mg
T0903131 Besylate
Once daily, oral
Placebo
Once daily, oral
Placebo
Once daily, oral
Interventions
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T0903131 Besylate
Once daily, oral
Placebo
Once daily, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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InteKrin Therapeutics, Inc.
INDUSTRY
Locations
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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
Countries
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References
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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.
Other Identifiers
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T-131-004
Identifier Type: -
Identifier Source: org_study_id
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