Status:
COMPLETED
Assessment of the Effects of a DPP-4 Inhibitor (Sitagliptin) Januvia on Immune Function in Healthy Individuals
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus Type 1
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Patients with diabetes have high blood sugar levels (hyperglycemia) because pancreatic beta-cells no longer produce sufficient insulin. Insufficient beta-cell function can be caused by an autoimmune k...
Detailed Description
Patients with diabetes have high blood sugar levels (hyperglycemia) because pancreatic b-cells no longer produce sufficient insulin. Insufficient b-cell function can be caused by an autoimmune killing...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2019
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00813228
Start Date
January 6 2009
End Date
November 26 2019
Last Update
November 29 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892