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 Sharp & Dohme Corp.
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
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective, Observational Study to Assess the Effectiveness of Glycemic Control of Diabetes in Real World After Sitagliptin Usage

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment: 1120
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 2 Diabetes Mellitus, No treatment

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316835

Contacts
Contact: Ching-Jung Hsieh, MD 886-7-7317123 rose@adm.cgmh.org.tw

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospita Recruiting
Kaohsiung, Taiwan
Contact: Ching-Jung Hsieh, MD    886-7-7317123    rose@adm.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ching-Jung Hsieh, MD Kaohsiung Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Ching-Jung Hsieh/ Head of department, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01316835     History of Changes
Other Study ID Numbers: 99-2717B
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Chang Gung Memorial Hospital:
retrospective,sitagliptin, glycemia control,real world

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014