Effectiveness of Sitagliptin in Glycemic Control in Real World

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Retrospective, Observational Study to Assess the Effectiveness of Glycemic Control of Diabetes in Real World After Sitagliptin Usage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01316835
• Other study ID #: 99-2717B
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2011
• Last updated: March 15, 2011
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: Chang Gung Memorial Hospital
• Contact: Ching-Jung Hsieh, MD
• Phone: 886-7-7317123
• Email: rose[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study will evaluate whether the addition of sitagliptin treatment provides additional decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic control on their current oral anti-glycemic therapy in real world practice.

Description:

To explore the change of glycemic control (HbA1c or FPG) before and after 24 weeks of Sitagliptin treatment in Type 2 Diabetic patients who have started Sitagliptin as add on therapy during the index period and received Sitagliptin continuously* for at least 24 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1120
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. All subjects diagnosed of type 2 diabetes (ICD-9 code= 250.0; 250.1; 250.2; 250.3; 250.4; 250.5; 250.6) and have been followed up regularly in the study center who have started to receive Sitagliptin as an add-on treatment to their prior regimen during the index period

2. Subjects must be on a stable dose of all antidiabetic regimens, with stable dose defined as "at least 3 months with no therapy/dose change" prior to adding sitagliptin

3. Subjects in whose medical records a minimum core data set can be found.

4. Outpatient

Exclusion Criteria:

1. Subjects with type 1 DM

2. Subjects have been treated with insulin regularly

3. Subject with DM which results from other general diseases, e.g. surgery, pharmaceutical products, malnutrition, infections and other conditions

4. Subjects who participated in a clinical trial or other clinical study during the index period

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospita	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Taiwan,