Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes, Atherosclerosis

In brief

The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4 inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2 diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this double blinded cross over study where they will receive a sitagliptin pill once a day for 8 weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods are divided by a 4 week period. Blood vessel function will be measured by ultrasound before and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment with each. Blood will also be taken to measure blood markers of inflammation at each time the ultrasounds are performed.

Key facts

Study ID

NCT01859793

Run by

Medical College of Wisconsin

People needed

38

Starts

2013-06-01

Expected to finish

2016-07-01

Last updated by the study team

2016-10-21

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult age 21-70 years of age.
• Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%.
• On stable metformin therapy for at least 6 weeks prior to enrollment.
• Glycosylated Hemoglobin ≥6.2% and ≤ 9.5%.

You may not qualify if…

• History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 50% on angiography or by confirmed history of myocardial infarction by standard criteria.)
• Evidence of other evident major illness including chronic renal insufficiency (creatinine clearance less than 60 mL/min),chronic liver disease (AST or ALT greater than 2.5 x normal), or cancer currently undergoing systemic therapy or had systemic therapy for cancer within 1 year of enrollment.
• Pregnancy as determined by urinary beta-HCG test
• Illicit drug use (heroin, cocaine etc) in the past 1 year.
• Alcohol abuse, defined as the equivalent of 14 beers/week for a man or 7 beers/week for a woman
• History of allergy to DPP-4 inhibitors at the time of screening/enrollment
• Prior history of pancreatitis
• Patients currently on insulin or sulfonylurea therapy.
• Patients currently on digoxin.

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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