Status:
UNKNOWN
Effect of Sitagliptin in Impaired Glucose Tolerance
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Impaired Glucose Tolerance
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the safety and efficacy of sitagliptin 100 mg every day (q.d.) in improving hyperglycemia and endothelial dysfunction in subjects with impaired glucose toleranc...
Eligibility Criteria
Inclusion
- Chinese subjects aged 40-65 years with fasting plasma glucose \< 100 mg/dL and OGTT 2-hour glucose 140-199 mg/dL.
- Subjects are judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests.
- Subject has an understanding of the study procedures, alternative treatments available and risk involved with the study, and voluntarily agrees to participate by giving written informed consent.
- Non-sterilized premenopausal female agrees to receive pregnancy test to confirm the non-pregnancy status and use adequate contraceptive methods to prevent pregnancy during the study period. Patient status should be confirmed by pregnancy test before enrollment.
Exclusion
- Evidence of diabetes (FPG\> 125 mg/dL, or OGTT 2-hour glucose\>=200 mg/dL, or current use of an anti-diabetic agents, except for history of gestational diabetes).
- History of intolerance or hypersensitivity or contraindication as mentioned in the approved package insert (appendix).
- Patient has any of the following disorders within the past 6 months: acute coronary syndrome (e.g., MI or unstable angina), coronary artery intervention (e.g., CABG or PTCA), stroke or transient ischemic neurological disorder.
- Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
- Patient has a BMI \> 40 kg/m2.
- Patient is on or likely to require more than 14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. Note: inhaled, nasal, and topical corticosteroids are permitted.
- Patient is on or likely to require treatment with immunosuppressive agents (e.g., cyclosporine, methotrexate).
- Advanced renal insufficiency (estimated creatinine clearance \< 50 ml/min).
- Severe hepatic insufficiency (Child-Pugh score \> 9, see Appendix).
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00961363
Start Date
December 1 2009
Last Update
March 22 2010
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100