Effectiveness of Sitagliptin in Glycemic Control in Real World
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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 |
| 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 |
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:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Ching-Jung Hsieh, MD | 886-7-7317123 | rose@adm.cgmh.org.tw |
| Taiwan | |
| Kaohsiung Chang Gung Memorial Hospita | Recruiting |
| Kaohsiung, Taiwan | |
| Contact: Ching-Jung Hsieh, MD 886-7-7317123 rose@adm.cgmh.org.tw | |
| 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 Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013