Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacological therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief summary:
The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Detailed description:
This is a phase 4, multicenter, randomized, double-blind, parallel-group, comparative study using placebo (Treatment Period I) and a phase 4, multicenter, open-label, long-term study (Treatment Period II) to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Arms:
arm 1: One tablet of SYR-472 100 mg orally once weekly before breakfast arm 2: One tablet of SYR-472 100 mg orally or one placebo tablet orally once weekly before breakfast

Interventions: intervention 1: SYR-472 intervention 2: Placebo
Intervention descriptions: intervention 1: SYR-472 tablets intervention 2: Placebo tablets

Protocol document: