Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

A Phase III, Multicenter, Open-label Long-term Treatment Trial to Assess the Safety and Efficacy of Addition of Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy

This is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.

Inclusion Criteria:

• Has Type 2 diabetes mellitus
• Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
• Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

Exclusion Criteria:

• History of type 1 diabetes mellitus or a history of ketoacidosis
• History of any of the following medications: Thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
• Currently has a urinary tract infection or genital infection with subjective symptom