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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
one 50 mg tablet QD
one 50 mg tablet QD
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
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.
Time frame: Up to 54 weeks
Percentage of Participants Who Had Study Drug Discontinued Due to an AE
The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.
Time frame: Up to 52 weeks
Change From Baseline in HbA1c
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.
Time frame: Baseline and Week 52
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