Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipragliflozin

Drug

one 50 mg tablet QD

Sitagliptin

Drug

one 50 mg tablet QD

Primary outcomes

Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)

Time frame: Up to 54 weeks

An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded.
Percentage of Participants Who Had Study Drug Discontinued Due to an AE

Time frame: Up to 52 weeks

The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.

Secondary outcomes

Change From Baseline in HbA1c

Time frame: Baseline and Week 52

Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Sep 30, 2015
Registry last updated: Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed