Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02577016

0431J-842

153096 (Registry Identifier)

Details and patient eligibility

About

This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.

Enrollment: 141 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 ipragliflozin 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, sitagliptin within 8 weeks prior to study participation.
• 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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141 participants in 2 patient groups

Sitagliptin + Ipragliflozin

Experimental group

Description:

Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.

Treatment:

Drug: Sitagliptin

Drug: Ipragliflozin

Placebo + Ipragliflozin

Active Comparator group

Description:

Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.

Treatment:

Drug: Ipragliflozin

Drug: Placebo