The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions. In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.
Study Type
OBSERVATIONAL
Enrollment
18,000
Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)
Incidence of adverse events
Time frame: up to 3 years
Incidence of cardiovascular events
Time frame: up to 3 years
Incidence of cancer
Time frame: up to 3 years
The change from baseline in vital signs and laboratory data
Time frame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
Incidence of other adverse events
Time frame: up to 3 years
Incidence of drug-related adverse events
Time frame: up to 3 years
Incidence of serious adverse events
Time frame: up to 3 years
The change from baseline in HbA1c
Time frame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
The change from baseline in Fasting Plasma Glucose
Time frame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
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