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

NCT02577003 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2018-09-04

Study results available
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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.

Conditions

Interventions

DRUG

Ipragliflozin

50 mg tablet administered orally

DRUG

Placebo

Placebo to ipragliflozin tablet administered orally

DRUG

Sitagliptin

Background medication; 50 mg tablet administered orally

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2016-11-25
Completion
2016-11-25

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577003 on ClinicalTrials.gov