Conditions: Type 2 Diabetes Mellitus
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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 367
Healthy volunteers: no

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-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.

Detailed description:

Arms:
arm 1: INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl. arm 2: INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl arm 3: INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl arm 4: INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl arm 5: pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate arm 6: placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl

Interventions: intervention 1: INT131 besylate intervention 2: Pioglitazone HCl intervention 3: Placebo
Intervention descriptions: intervention 1: Once-daily, oral intervention 2: Once-daily, oral intervention 3: Once-daily, oral

Protocol document: