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This study investigates the effects of the DPP-4 inhibitor Sitagliptin (Januvia) on immune system function in healthy individuals. It included healthy volunteers over 18 without diabetes or autoimmune disease. It was a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* INCLUSION CRITERIA: Age greater than 18 Fasting blood glucose less than 100 mg/dl, and a normal Hgb A1c (less than 5.7%), Available for follow up through 9 weeks. In good general health without clinically significant medical history as deemed by study investigators. EXCLUSION CRITERIA: History of diabetes or other autoimmune diseases including (but not limited to) rheumatoid arthritis, lupus, multiple sclerosis. Active hepatitis B, C and/ or HIV infection. Recent diagnosis or active treatment for malignancy. Recent (within 3 weeks) severe allergy symptoms such as allergy-induced asthma, skin eruptions or urticaria. Recent (within 3 weeks) viral or bacterial infections. History of other immune abnormalities, or the presence of disease processes or medications that, in the opinion of the investigator, may alter immune function. Pregnant and nursing females. Women who have child-bearing potential but not using adequate birth control. History of hypersensitivity reaction to sitagliptin. History of anemia (based on the NIH laboratory department hemoglobin reference range for normal individuals). History of pancreatitis