Effect of Sitagliptin in Impaired Glucose Tolerance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00961363
First received: August 11, 2009
Last updated: March 19, 2010
Last verified: March 2010

August 11, 2009
March 19, 2010
December 2009
June 2011   (final data collection date for primary outcome measure)
the change in fasting and post-load plasma glucose levels during OGTT [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00961363 on ClinicalTrials.gov Archive Site
  • the changes in endothelial function, measured by circulating adhesion molecules [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • the changes in beta cell functions derived from the glucose/insulin levels during OGTT [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • the safety and the tolerability of sitagliptin, including clinical and laboratory adverse experiences, laboratory values, weight, and vital signs. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Sitagliptin in Impaired Glucose Tolerance
The Effect of Sitagliptin on Postprandial Glycemia and Endothelial Function in Chinese Subjects With Impaired Glucose Tolerance

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Impaired Glucose Tolerance
  • Drug: Sitagliptin
    sitagliptin 100 mg per day
  • Drug: Placebo
    Placebo
  • Experimental: Sitagliptin
    Sitagliptin
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
June 2011   (final data collection date for primary outcome measure)

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).
Both
40 Years to 65 Years
No
Contact: Lee-Ming Chuang, MD, PhD 886-2-23123456 ext 65038 leeming@ntu.edu.tw
Taiwan
 
NCT00961363
200904052M
No
Professor Lee-Ming Chuang, National Taiwan Univerisity Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Lee-Ming Chuang, MD, PhD Department of Internal Medicine, National Taiwan University Hospital
National Taiwan University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP