Overview

This trial has been completed.

Condition type 2 diabetes mellitus
Treatments ipragliflozin, placebo, sitagliptin
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date November 2015
End date November 2016
Trial size 143 participants
Trial identifier NCT02577003, 0431J-843, 153097

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
ipragliflozin
sitagliptin
Background medication
(Placebo Comparator)
Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
placebo
Placebo to ipragliflozin
sitagliptin
Background medication

Primary Outcomes

Measure
Change from Baseline in HbA1c at Week 24
time frame: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
time frame: Up to 26 weeks
Percentage of Participants Who Discontinued Study Drug due to an AE
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Change from Baseline in Fasting Plasma Glucose (FPG) at Week 24
time frame: Baseline and Week 24
Change from Baseline in 2-hr Post-Meal Glucose (PMG) at Week 24
time frame: Baseline and Week 24
Change from Baseline in Glucose Total Area Under the Plasma Concentration Curve from Hour 0 to Hour 2 (AUC0-2hr) after Meal at Week 24
time frame: Baseline and Week 24
Change from Baseline in Body Weight at Week 24
time frame: Baseline and Week 24

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Type 2 diabetes mellitus - Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy - 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 and 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, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind 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 December 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..