Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064714
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2003-07-10
Brief Title:
Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Effect of AC 2993 Synthetic Exendin-4 - Administered Alone or in Combination With Daclizumab - on Islet Function in Patients With Type I Diabetes
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 pancreass 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 bodys 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 bodys 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
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 pancreass 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 bodys 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 bodys 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
Detailed Description:
Type I diabetes mellitus T1DM typically results from immune mediated destruction of pancreatic beta cells Previous studies indicate that some patients retain the capacity for limited endogenous insulin production AC2993 synthetic exendin-4 has been shown in preclinical and in human studies to have several potentially beneficial antidiabetic actions including recovery and neogenesis of pancreatic islets Thus we plan to enroll adults with long-standing T1DM who have some C-peptide secretion indicating residual beta cell mass The latter will be targeted by AC2993 Due to the possibility of stimulating the underlying autoimmune process of T1DM especially if islet regeneration occurs we will subject half of the enrollees to immunosuppression We plan to study the effects of AC2993 alone immunosuppression daclizumab alone as well as the combination of AC2993 and immunosuppression on insulin secretion and glycemia control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-DK-0245 | None | None | None |