Specified Drug Use Results Survey of Ipragliflozin Treatm... | NCT02479399

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

NCT02479399

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 22, 2024Actual

Enrollment

11,412Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

ipragliflozin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2014Actual

Primary Completion Date

Oct 16, 2018Actual

Completion Date

Oct 16, 2018Actual

First Submitted Date

Jun 15, 2015

First Submission Date that Met QC Criteria

Jun 19, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2024

Last Update Posted Date

Oct 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Hypoglycemia
Genital infection
Urinary tract infection
Polyuria and pollakiuria
Adverse events related to a decrease in body fluids (dehydration, etc.)
Malignant tumor
Cardiovascular diseases

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11,412Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suglat group		Tablets	Drug: ipragliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ipragliflozin	Drug	Tablets	Suglat group	ASP1941 Suglat

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34567926	Derived	Maegawa H, Tobe K, Nakamura I, Uno S. Real-world evidence for long-term safety and effectiveness of ipragliflozin in treatment-naive versus non-naive Japanese patients with type 2 diabetes mellitus: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM). Diabetol Int. 2021 Mar 24;12(4):430-444. doi: 10.1007/s13340-021-00501-w. eCollection 2021 Oct.
33730336

Facility	Status	City	State	ZIP	Country	Contacts
		Chugoku			Japan

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases