Multicenter observational study of the efficancy of sitagliptin in patients at high risk of cardiovascular disease

Phase 4

Recruiting

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000005663
• Lead Sponsor: Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-01
• Study Completion: 2013-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

history of diabetic ketosis and coma within 6 month sepsis,before and after operation,severe injury pregnant woman,woman with chance of pregnancy dialysis patient,severe renal dysfunction hypersensitivity to the medicine a case determined inappropriate

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end-point is HbA1c measurement every three months for twelve months after introduction,addition or change from other drugs of sitagliptin in patinets at high risk of cardiovascular disease who failed to achieve the target blood glucose level despite diet, excise and anti-diabetic drug therapies.

Secondary Outcome Measures

Name	Time	Method
Other laboratory data, cardiovascular indices and adverse events will be analyzed as well.