Effect of Sitagliptin in Impaired Glucose Tolerance

NCT00961363 | Unknown Phase 2

• 1 other identifier: 200904052M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• the change in fasting and post-load plasma glucose levels during OGTT

  24 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sitagliptin DRUG

sitagliptin 100 mg per day

Sitagliptin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese subjects aged 40-65 years with fasting plasma glucose \< 100 mg/dL and OGTT 2-hour glucose 140-199 mg/dL.
• Subjects are judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests.
• 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.
• 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.

You may not qualify if:

• 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).
• History of intolerance or hypersensitivity or contraindication as mentioned in the approved package insert (appendix).
• 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.
• Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
• Patient has a BMI \> 40 kg/m2.
• 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.
• Patient is on or likely to require treatment with immunosuppressive agents (e.g., cyclosporine, methotrexate).
• Advanced renal insufficiency (estimated creatinine clearance \< 50 ml/min).
• Severe hepatic insufficiency (Child-Pugh score \> 9, see Appendix).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Lee-Ming Chuang, MD, PhD

  Department of Internal Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee-Ming Chuang, MD, PhD

CONTACT

886-2-23123456; leeming@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 18, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Last Updated: March 22, 2010

Record last verified: 2010-03

Locations

TW (1)