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Completed

NCT Number: NCT02479399

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chugoku, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipragliflozin

Drug

Tablets

Other names: ASP1941, Suglat

Primary outcomes

  1. Incidence of cardiovascular adverse events

    Time frame: Up to 3 years

  2. Incidence of malignant tumor

    Time frame: Up to 3 years

Secondary outcomes

  1. Safety developed by adverse events and laboratory tests

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)

Acronym: STELLALONGTERM

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2015
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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