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.

Study Overview

• Status: Unknown
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Placebo; Drug: Sitagliptin

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lee-Ming Chuang, MD, PhD; Phone Number: 65038 886-2-23123456; Email: leeming@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Lee-Ming Chuang, MD, PhD; Phone Number: 65038 886-2-23123456; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Sitagliptin	Drug: Sitagliptin; sitagliptin 100 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change in fasting and post-load plasma glucose levels during OGTT	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Lee-Ming Chuang, MD, PhD, Department of Internal Medicine, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 16, 2009
• First Posted (Estimate): August 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 22, 2010
• Last Update Submitted That Met QC Criteria: March 19, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 200904052M