Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients

Conditions

Type 2 Diabetes

Keywords

Suglat, SGLT-2 inhibitor, Ipragliflozin L-Proline, ASP1941 long-term use

Brief summary

The objective of this survey is to confirm the safety of Suglat Tablets

Detailed description

The objective of this survey is to confirm the safety and efficacy of Suglat Tablets for long-term use over 3 years. Specify the effects of Suglat Tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors. Investigate the occurrence of adverse drug reactions. Specify factors that may possibly influence the safety and efficacy of Suglat Tablets. \<Items of interest\> * Hypoglycemia * Genital infection * Urinary tract infection * Polyuria and pollakiuria * Adverse events related to a decrease in body fluids (dehydration, etc.) * Malignant tumor * Cardiovascular diseases

Maegawa H, Tobe K, Nakamura I, Uno S.

2021-03-242 citations

10.1007/s13340-021-00501-w

Safety and Effectiveness of Ipragliflozin in Elderly Versus Non-elderly Japanese Patients with Type 2 Diabetes: Subgroup Analysis of STELLA-LONG TERM

Ichiro Nakamura, Hiroshi Maegawa, Kazuyuki Tobe, Satoshi Uno

Diabetes Therapy2021-03-17

10.1007/s13300-021-01042-w

Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study.

Nakamura I, Maegawa H, Tobe K, Uno S.

2019-02-149 citations

10.1007/s12325-019-0895-1

Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice

Hiroshi Maegawa, Kazuyuki Tobe, Hiromi Tabuchi, Ichiro Nakamura

Expert Opinion on Pharmacotherapy2016-07-2724 citations

10.1080/14656566.2016.1217994

Interventions

DRUGipragliflozin

Tablets

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

Exclusion criteria

* off-label use patients

Design outcomes

Primary

Measure	Time frame
Incidence of cardiovascular adverse events	Up to 3 years
Incidence of malignant tumor	Up to 3 years

Secondary

Measure	Time frame
Safety developed by adverse events and laboratory tests	Up to 3 years

Countries

Japan

Outcome results

None listed