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Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial
Diabetes & Metabolism Journal ; : 135-145, 2017.
Article in English | WPRIM | ID: wpr-110916
ABSTRACT

BACKGROUND:

This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin.

METHODS:

This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea.

RESULTS:

Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were –0.97% in the ipragliflozin group and –0.31% in the placebo group, with an adjusted between-group difference of –0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of –21.4 mg/dL and –1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection.

CONCLUSION:

Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Asia / Urinary Tract Infections / Blood Glucose / Body Weight / Fasting / Diabetes Mellitus, Type 2 / Korea / Metformin Type of study: Controlled clinical trial Limits: Humans Country/Region as subject: Asia Language: English Journal: Diabetes & Metabolism Journal Year: 2017 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Asia / Urinary Tract Infections / Blood Glucose / Body Weight / Fasting / Diabetes Mellitus, Type 2 / Korea / Metformin Type of study: Controlled clinical trial Limits: Humans Country/Region as subject: Asia Language: English Journal: Diabetes & Metabolism Journal Year: 2017 Type: Article