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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Ipragliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02564211

0431J-849

153083 (Registry Identifier)

MK-0431J-849 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

77 participants in 1 patient group

Ipragliflozin

Experimental group

Description:

Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.

Treatment:

Drug: Ipragliflozin

Drug: Sitagliptin