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Effectiveness of Sitagliptin in Glycemic Control in Real World

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: March 16, 2011
Last Update Posted: March 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Merck Sharp & Dohme Corp.
Information provided by:
Chang Gung Memorial Hospital
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.

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)
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.

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316835

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

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.
Principal Investigator: Ching-Jung Hsieh, MD Chang Gung Memorial Hospital
  More Information

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
First Submitted: March 15, 2011
First Posted: March 16, 2011
Last Update Posted: March 16, 2011
Last Verified: March 2011

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 Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action