Conditions: Type 2 Diabetes Mellitus
Keywords: AC-201 Interleukin 1 inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 259
Healthy volunteers: no

Brief summary:
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.

Detailed description:

Arms:
arm 1: 25mg BID for 24 weeks arm 2: 50mg BID for 24 weeks arm 3: 75mg BID for 24 weeks arm 4: Placebo BID for 24 weeks

Interventions: intervention 1: AC-201, 25mg intervention 2: AC-201, 50mg intervention 3: AC-201, 75mg intervention 4: Placebo
Intervention descriptions: intervention 1: Capsule, 25mg BID intervention 2: Capsule, 50mg BID intervention 3: Capsule, 75mg BID intervention 4: Placebo BID

Protocol document: