A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.

Key facts

Study ID

NCT00631007

Run by

InteKrin Therapeutics, Inc.

People needed

367

Starts

2008-02-01

Expected to finish

2009-09-01

Last updated by the study team

2010-09-13

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• National Research Institute — Los Angeles, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Internal Medicine of the Rockies — Colorado Springs, Colorado, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• Clinical Research Consulting, LLC — Milford, Connecticut, United States
• MedStar Research Institute — Washington D.C., District of Columbia, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• The Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• Baptist Diabetes Associates, PA — Miami, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Elite Research Institute — Miami, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Suncoast Clinical Research, Inc. — Palm Harbor, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Clinical Research of Central Florida — Winter Haven, Florida, United States
• Executive Health and Research Associates, Inc. — Atlanta, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Cedar-Crosse Research Center — Chicago, Illinois, United States
• ICCT Reseach International — Chicago, Illinois, United States
• American Health Network — Indianapolis, Indiana, United States
• L-Marc Research Center — Louisville, Kentucky, United States
• New Orleans Center for Clinical Research — New Orleans, Louisiana, United States
• Northern California Research — Carmichael, California, United States

Full record on ClinicalTrials.gov

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