Effect of Saxagliptin Treatment on Myocardial Fat Content, and Monocyte Inflammation

• Status: Terminated
• Trial end date: 2017-08-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to examine the effect of saxagliptin, an anti-diabetes medication, on hepatic and myocardial fat content and monocyte inflammation in patients with Impaired Glucose Tolerance (IGT).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Saxagliptin

Criteria

Inclusion Criteria:

• Men and women with a diagnosis diagnosis of Impaired Glucose Tolerance i.e. fasting plasma glucose less than or equal to 125 mg/dl, 2 hour post 75 gram oral glucose tolerance test (OGTT) plasma glucose between 140-199 mg/dl, glycosylated hemoglobin A1c (HbA1c) less than 6.5% as per American Diabetes Association (ADA) criteria.

• Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

• Patients must not be on anti-diabetes therapy for treatment of Impaired Glucose Tolerance (IGT) and must have a fasting plasma glucose concentration less or equal to 125 mg/dl.

• Type 1 or Type 2 diabetes mellitus (fasting plasma glucose greater than 125 mg/dl).

• Patients must not be on or have received metformin, thiazolidinediones, sulfonylureas, DPP IV inhibitor, or exenatide/liraglutide treatment for treatment of IGT at any time. Patients must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications such as hormone replacement therapy with known adverse effects on glucose tolerance levels. Patients taking systemic glucocorticoids will also be excluded.

• Subjects with a history of clinically significant heart disease, peripheral vascular disease, or pulmonary disease.

• Subjects must have a Body Mass Index between 30-35 kg/m2 and stable body weight.

• Subjects must not have clinically significant liver disease (aspartate aminotransferase (AST) < 2.5 times upper limit of normal, Alanine transaminase (ALT) < 2.5 times upper limit of normal, Alkaline phosphatase< 2.5 times upper limit of normal), kidney disease (Serum creatinine < 1.5 mg/dl in men and 1.4 mg/dl in women) or significant anemia (Hematocrit < 34 vol%).

• Subjects with a history of any serious hypersensitivity reaction to saxagliptin or a dipeptidyl peptidase 4 (DPP-IV) inhibitor.

• Concomitant treatment with systemic cytochrome P450 3A4 inducers.

• Women who are pregnant or breastfeeding