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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Impaired Glucose Tolerance

In brief

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).

Key facts

Study ID

NCT01548651

Run by

Baylor College of Medicine

People needed

8

Starts

2012-02-01

Expected to finish

2017-08-25

Last updated by the study team

2020-01-13

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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