Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments ipragliflozin, sitagliptin
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date October 2015
End date March 2017
Trial size 75 participants
Trial identifier NCT02564211, 0431J-849, 153083

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ipragliflozin once daily for 52 weeks with sitagliptin, diet, and exercise.
ipragliflozin
sitagliptin
Background medication

Primary Outcomes

Measure
Percentage of participants who experienced at least one adverse event (AE)
time frame: Up to 54 weeks
Percentage of participants who discontinued from the study drug due to an AE
time frame: Up to 52 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..