A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: INT131 besylate; Pioglitazone HCl; Placebo
Intervention description: Once-daily, oral; Once-daily, oral; Once-daily, oral
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 367.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; diabetes; diabetes mellitus; diabetes mellitus, type 2; non-TZD; thiazolidinedione; selective peroxisome proliferator-activated receptor gamma modulator; SPPARM; peroxisome proliferator-activated receptor gamma; PPAR gamma; insulin sensitizer; glucose control; endocrinopathy; hypoglycemic agent; sulfonylurea; metformin; pioglitazone; nutritional and metabolic diseases

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-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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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)