Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Ipragliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02577003

153097 (Registry Identifier)

0431J-843

Details and patient eligibility

About

This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.

Enrollment: 143 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
• HbA1c ≥7.0% and ≤10.0% before study start

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 and 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 2 patient groups

Ipragliflozin + Sitagliptin

Experimental group

Description:

Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.

Treatment:

Drug: Ipragliflozin

Drug: Sitagliptin

Placebo + Sitagliptin

Active Comparator group

Description:

Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.

Treatment:

Drug: Placebo

Drug: Sitagliptin