Effect of Sitagliptin in Impaired Glucose Tolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00961363
Recruitment Status : Unknown
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 18, 2009
Last Update Posted : March 22, 2010
Information provided by:
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Drug: Sitagliptin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sitagliptin on Postprandial Glycemia and Endothelial Function in Chinese Subjects With Impaired Glucose Tolerance
Study Start Date : December 2009
Estimated Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sitagliptin
Drug: Sitagliptin
sitagliptin 100 mg per day

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. the change in fasting and post-load plasma glucose levels during OGTT [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. the changes in endothelial function, measured by circulating adhesion molecules [ Time Frame: 24 weeks ]
  2. the changes in beta cell functions derived from the glucose/insulin levels during OGTT [ Time Frame: 24 weeks ]
  3. the safety and the tolerability of sitagliptin, including clinical and laboratory adverse experiences, laboratory values, weight, and vital signs. [ Time Frame: 24 weeks ]

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00961363

Contact: Lee-Ming Chuang, MD, PhD 886-2-23123456 ext 65038

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Lee-Ming Chuang, MD, PhD    886-2-23123456 ext 65038   
Principal Investigator: Lee-Ming Chuang, MD, PhD         
Sub-Investigator: Hung-Yuan Li, MD         
Sub-Investigator: Hung-Ju Lin, MD         
Sub-Investigator: Chia-Hsiung Chang, MD, PhD         
Sub-Investigator: Shyang-Rong Shih, MD         
Sub-Investigator: Tien-Jyun Chang, MD, PhD         
Sub-Investigator: Jaw-Shiun Tsai, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Lee-Ming Chuang, MD, PhD Department of Internal Medicine, National Taiwan University Hospital

Responsible Party: Professor Lee-Ming Chuang, National Taiwan Univerisity Hospital Identifier: NCT00961363     History of Changes
Other Study ID Numbers: 200904052M
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: March 22, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action