Status:
COMPLETED
A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Lead Sponsor:
InteKrin Therapeutics, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbeari...
Eligibility Criteria
Inclusion
- Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
- Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
- HbA1c must be ≥7.5% and ≤10% at screening
- Fasting Plasma Glucose must be \<240 mg/dL at screening
Exclusion
- History of type 1 diabetes
- History of diabetic ketoacidosis
- NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
- Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
- Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
- Body mass index \>45 kg/m2
- Fasting triglycerides \>500 mg/dL
- Uncontrolled hypertension (sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>100 mmHg
- Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00631007
Start Date
February 1 2008
End Date
September 1 2009
Last Update
September 13 2010
Active Locations (66)
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1
Northern California Research
Carmichael, California, United States, 95608
2
National Research Institute
Los Angeles, California, United States, 90057
3
VA San Diego Healthcare System
San Diego, California, United States, 92161
4
Apex Research Institute
Santa Ana, California, United States, 92705