Clinical trial NCT00961363: Effect of Sitagliptin in Impaired Glucose Tolerance
Official title: The Effect of Sitagliptin on Postprandial Glycemia and Endothelial Function in Chinese Subjects With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 tolerance.


Eligibility criteria: Inclusion Criteria:

1. Chinese subjects aged 40-65 years with fasting plasma glucose \< 100 mg/dL and OGTT 2-hour glucose 140-199 mg/dL.
2. Subjects are judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests.
3. 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.
4. 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 Criteria:

1. 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).
2. History of intolerance or hypersensitivity or contraindication as mentioned in the approved package insert (appendix).
3. 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.
4. Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
5. Patient has a BMI \> 40 kg/m2.
6. 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.
7. Patient is on or likely to require treatment with immunosuppressive agents (e.g., cyclosporine, methotrexate).
8. Advanced renal insufficiency (estimated creatinine clearance \< 50 ml/min).
9. Severe hepatic insufficiency (Child-Pugh score \> 9, see Appendix).

Primary outcomes:
measure: the change in fasting and post-load plasma glucose levels during OGTT
timeFrame: 24 weeks
Secondary outcomes:
measure: the changes in endothelial function, measured by circulating adhesion molecules
timeFrame: 24 weeks
measure: the changes in beta cell functions derived from the glucose/insulin levels during OGTT
timeFrame: 24 weeks
measure: the safety and the tolerability of sitagliptin, including clinical and laboratory adverse experiences, laboratory values, weight, and vital signs.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine, National Taiwan University Hospital
name: Lee-Ming Chuang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: