Effectiveness of Sitagliptin in Glycemic Control in Real World

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01316835
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 15, 2011
March 15, 2011
December 2010
December 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Sitagliptin in Glycemic Control in Real World
A Retrospective, Observational Study to Assess the Effectiveness of Glycemic Control of Diabetes in Real World After Sitagliptin Usage

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Subjects with ICD-9 diagnostic codes of T2DM plus any prescription record of the anti-glycemic drugs included in the hospital formulary during the study period will be extracted from the hospital outpatient electronic database. Sitagliptin users who stayed with Sitagliptin for at least 24 weeks will then further identified from this diabetes cohort for efficacy analysis.

Type 2 Diabetes Mellitus
Not Provided
Type 2 Diabetes Mellitus, No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1120
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Ching-Jung Hsieh, MD 886-7-7317123 rose@adm.cgmh.org.tw
Taiwan
 
NCT01316835
99-2717B
No
Ching-Jung Hsieh/ Head of department, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Merck
Principal Investigator: Ching-Jung Hsieh, MD Kaohsiung Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP