Effectiveness of Sitagliptin in Glycemic Control in Real World

NCT01316835 | Unknown

• 1 other identifier: 99-2717B
• Study Type: observational
• Target: 1,120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

retrospective,sitagliptin, glycemia control,real world

Study Arms (1)

Type 2 Diabetes Mellitus, No treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Subjects with type 1 DM
• Subjects have been treated with insulin regularly
• Subject with DM which results from other general diseases, e.g. surgery, pharmaceutical products, malnutrition, infections and other conditions
• Subjects who participated in a clinical trial or other clinical study during the index period

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospita

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ching-Jung Hsieh, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Jung Hsieh, MD

CONTACT

886-7-7317123; rose@adm.cgmh.org.tw

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 16, 2011

Record last verified: 2011-03

Locations

TW (1)