Clinical trial NCT00952445: A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type II
Lead sponsor: InteKrin Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Whittier Diabetes Institute
state: California
city: Los Angeles
country: United States
facility: Charles R. Drew University
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Santa Ana
country: United States
facility: Lovelace Research Institute
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Evansville
country: United States
facility: GFI Research Center
state: Indiana
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Saint Louis
country: United States
facility: St Louis Center for Clinical Research
state: Missouri
city: Buffalo
country: United States
facility: Kaleida Health Diabetes Center
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Research Center
state: Texas
city: Dallas
country: United States
facility: Endocrine Associates of Dallas
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Grandular Disease Clinic and Reseach Center
state: Texas
city: Ogden
country: United States
facility: Endocrine Research Specialists
state: Utah
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
Study officials:
References:
citation: 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.