Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427083
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-14
Brief Title:
Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
Sponsor:
Daewoong Pharmaceutical Co LTD
Organization:
Daewoong Pharmaceutical Co LTD
Study Overview
Official Title:
An Anonymized De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study is designed to assess the effects of Envlo Tablet or Envlomet SR Tablet on weight loss and safety in patients with Type 2 diabetes conducted in real primary care settings over a period of 24 weeks
Detailed Description:
The study plans to recruit patients with Type 2 diabetes who are scheduled to receive Envlo Tablet or Envlomet SR Tablet based on the attending physicians medical judgment regardless of previous diabetes treatment However voluntary consent from patients is required for participation in the study even if Envlo Tablet or Envlomet SR Tablet are prescribed
Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation capturing demographic information physical measurements vital signs and lifestyle factors Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data including clinical indicators safety evaluations and adverse events Data will be collected based on routine clinical records with no mandatory study-specific visits or interventions
Overall this observational study aims to collect data on demographics physical measurements vital signs and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings utilizing information obtained during routine patient care processes
Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation capturing demographic information physical measurements vital signs and lifestyle factors Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data including clinical indicators safety evaluations and adverse events Data will be collected based on routine clinical records with no mandatory study-specific visits or interventions
Overall this observational study aims to collect data on demographics physical measurements vital signs and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings utilizing information obtained during routine patient care processes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None