Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGSGLT2 Inhibitors
Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)
Sponsors
Pharmaceuticals and Medical Devices Agency, Japan
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cancer | up to 3 years |
| The change from baseline in vital signs and laboratory data | Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration |
| Incidence of other adverse events | up to 3 years |
| Incidence of cardiovascular events | up to 3 years |
| Incidence of serious adverse events | up to 3 years |
| The change from baseline in HbA1c | Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration |
| The change from baseline in Fasting Plasma Glucose | Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration |
| Incidence of drug-related adverse events | up to 3 years |
Outcome results
None listed