The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

Type 2 Diabetes Clinical Trial

— STELLA-ELDER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297620
• Other study ID #: SGL001
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: October 14, 2015
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

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

2. Investigate the occurrence of urinary tract infection.

3. 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).

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

5. Factors that may possibly influence the safety of Suglat Tablets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8687
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• off-label use patients

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Suglat®
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors		Up to 12 months	Yes
Secondary	Investigate the occurrence of urinary tract infection		1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)	Yes
Secondary	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).		1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)	Yes
Secondary	Investigate the occurrence of adverse drug reactions other than the above		1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)	Yes