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
  Purpose

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 Intervention Phase
Impaired Glucose Tolerance
Drug: Sitagliptin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sitagliptin on Postprandial Glycemia and Endothelial Function in Chinese Subjects With Impaired Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the change in fasting and post-load plasma glucose levels during OGTT [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin
Drug: Sitagliptin
sitagliptin 100 mg per day
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961363

Contacts
Contact: Lee-Ming Chuang, MD, PhD 886-2-23123456 ext 65038 leeming@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Lee-Ming Chuang, MD, PhD    886-2-23123456 ext 65038    leeming@ntu.edu.tw   
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
Investigators
Principal Investigator: Lee-Ming Chuang, MD, PhD Department of Internal Medicine, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Professor Lee-Ming Chuang, National Taiwan Univerisity Hospital
ClinicalTrials.gov Identifier: NCT00961363     History of Changes
Other Study ID Numbers: 200904052M
Study First Received: August 11, 2009
Last Updated: March 19, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014