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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Adult age 21-70 years of age.

2. 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%.

3. On stable metformin therapy for at least 6 weeks prior to enrollment.

4. Glycosylated Hemoglobin ≥6.2% and ≤ 9.5%.

Exclusion Criteria:

1. 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.)

2. 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.

3. Pregnancy as determined by urinary beta-HCG test

4. Illicit drug use (heroin, cocaine etc) in the past 1 year.

5. Alcohol abuse, defined as the equivalent of 14 beers/week for a man or 7 beers/week for a woman

6. History of allergy to DPP-4 inhibitors at the time of screening/enrollment

7. Prior history of pancreatitis

8. Patients currently on insulin or sulfonylurea therapy.

9. Patients currently on digoxin.

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