Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the
ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on
beta cell function.
Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells
of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve
the pancreas's ability to produce insulin and help control blood sugar, but it may also
activate the original immune response that caused the diabetes. Thus, this study will examine
the effects of AC2993 alone as well as in combination with immunosuppressive drugs.
Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for
this 20-month study. They must have had diabetes for at least 5 years and require insulin
treatment. Candidates will be screened with a questionnaire, followed by medical history and
physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis,
electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below).
Participants will undergo the following tests and procedures:
Advanced screening phase: Participants undergo a diabetes education program, including
instruction on frequent blood glucose monitoring, dietary education on counting
carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar
(hypoglycemia), and potential treatment with glucagon shots.
Patients must administer insulin via an insulin pump or take at least four injections per day
including glargine (Lantus) insulin.
4-month run-in phase
- Arginine-stimulated C-peptide test: This test measures the body's insulin production.
The patient is injected with a liquid containing arginine, a normal constituent of food
that increases insulin release from beta cells into the blood stream. After the
injection, seven blood samples are collected over 10 minutes.
- Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response
of the beta cells to an ordinary meal and the time it takes for food to pass through the
stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood
samples are then drawn through a catheter (plastic tube placed in a vein) every 30
minutes for 4 hours to measure levels of various hormones and the concentration of
acetaminophen.
- Euglycemic clamp: This test measures the body's level of insulin resistance by measuring
the amount of glucose necessary to compensate for an increased insulin level while
maintaining a prespecified blood glucose level.
Phase:
Phase 2
Details
Lead Sponsor:
AstraZeneca
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)