Effect of Sitagliptin in Impaired Glucose Tolerance

Impaired Glucose Tolerance Clinical Trial

Official title:

The Effect of Sitagliptin on Postprandial Glycemia and Endothelial Function in Chinese Subjects With Impaired Glucose Tolerance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00961363
• Other study ID #: 200904052M
• Status: Recruiting
• Phase: Phase 2
• First received: August 11, 2009
• Last updated: March 19, 2010
• Start date: December 2009

Study information

• Verified date: March 2010
• Source: National Taiwan University Hospital
• Contact: Lee-Ming Chuang, MD, PhD
• Phone: 886-2-23123456
• Email: leeming[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• Sitagliptin
sitagliptin 100 mg per day
• Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in fasting and post-load plasma glucose levels during OGTT		24 weeks	No
Secondary	the changes in endothelial function, measured by circulating adhesion molecules		24 weeks	No
Secondary	the changes in beta cell functions derived from the glucose/insulin levels during OGTT		24 weeks	No
Secondary	the safety and the tolerability of sitagliptin, including clinical and laboratory adverse experiences, laboratory values, weight, and vital signs.		24 weeks	Yes