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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479399
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
The objective of this survey is to confirm the safety of Suglat Tablets

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: ipragliflozin

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
Study Design
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Study Type : Observational
Actual Enrollment : 11412 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)
Actual Study Start Date : July 17, 2014
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Suglat group
Tablets
 Drug: ipragliflozin
Tablets
Other Names:
  • ASP1941
  • Suglat


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of cardiovascular adverse events [ Time Frame: Up to 3 years ]
  2. Incidence of malignant tumor [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Safety developed by adverse events and laboratory tests [ Time Frame: Up to 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479399


Locations
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Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Tohoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02479399    
Other Study ID Numbers: SGL002
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc:
Suglat
SGLT-2 inhibitor
Ipragliflozin L-Proline
ASP1941 long-term use
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Ipragliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs