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

• Status: Completed
• Trial end date: 2017-03-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ipragliflozin; Sitagliptin Phosphate

Criteria

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