Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the blood . Research has shown that improving the survival of these special blood cells may decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart disease. Saxagliptin is an FDA(Food and Drug Administration) approved prescription medicine used along with diet and exercise to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called DPP-4 inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes. Hypothesis: We believe poor viability and function of EPCs in early diabetes ultimately affects the repair and regeneration of the endothelium and that prompt intervention using saxagliptin with another oral hypoglycemic agent, Metformin, may reduce or reverse cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control.

Key facts

Study ID

NCT02024477

Run by

George Washington University

People needed

42

Starts

2013-11-01

Expected to finish

2017-12-01

Last updated by the study team

2019-02-15

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 40-70 years.
• Diagnosis of type 2 diabetes within the previous 8 years using criteria of the American Diabetes Association
• Currently treated with no hypoglycemic agents other than a stable dose (>3 months) of metformin (≥1.0 to ≤2 grams daily).
• HbA1C between 6 to 9% (both inclusive)
• BMI 25 to 39.9 kg/m2 (both inclusive)

You may not qualify if…

• Contraindications for moderate exercise
• Implanted devices (e.g., pacemakers) that may interact with Tanita scale
• Previous coronary or cerebrovascular event within 6 months of screening or active or clinically significant coronary and/or peripheral vascular disease.
• Low hematocrit <28 Units
• Pre-existing liver disease and/or ALT and AST >2.5X's UNL
• Kidney disease (serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/dL for women,Creatinine Clearance ≤50 mL/min)
• History of pancreatitis, or cancer (except basal cell carcinoma)
• Statin use started (or dose change) in the last 3 months.
• Use of oral or injectable anti-diabetic medication other than Metformin
• Use of any form of consistent-long term steroid medication (oral, inhaled injected or nasal) within the last 3 months
• Systolic BP> 140 mmHg and diastolic BP> 90 mmHg
• Active wounds or recent surgery within 3 months.
• Inflammatory disease, or current use of anti-inflammatory drugs
• triglycerides >400 mg/dL
• untreated hyper/hypothyroidism Additionally, patients who are active smokers, patients who are pregnant, nursing women, and post menopausal women who are on hormone replacement therapy will be excluded.
• Patients on low dose oral contraceptives will be allowed to participate as these formulations contain lesser amount of estrogens.

Where it is running

• Medical Faculty Associates Inc — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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