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Completed

NCT Number: NCT02297620

The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.

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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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chugoku, Japan

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About this study

Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.

  • Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.
  • Investigate the occurrence of urinary tract infection.
  • Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
  • Investigate the occurrence of adverse drug reactions other than the above.
  • Factors that may possibly influence the safety of Suglat Tablets.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes who used Suglat Tablets within 3 months from its launch

Exclusion criteria

  • off-label use patients

Treatment and study plan

Suglat®

Drug

oral

Other names: ipragliflozin

Primary outcomes

  1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors

    Time frame: Up to 12 months

Secondary outcomes

  1. Investigate the occurrence of urinary tract infection

    Time frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

  2. Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).

    Time frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

  3. Investigate the occurrence of adverse drug reactions other than the above

    Time frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)

Acronym: STELLA-ELDER

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Oct 15, 2015

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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