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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00064714 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: AC2993 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Enrollment: | 47 |
| Study Start Date: | July 2003 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
T1DM for at least 5 years as defined by the following:
C-peptide greater than or equal to 0.3 and less than or equal to 1.2 ng/mL at baseline or during an arginine-stimulated C-peptide test.
Age 18 to 60 years, inclusive.
EXCLUSION CRITERIA:
Symptomatic gastroparesis.
Diabetic nephropathy with a creatinine clearance less than 60 cc/min or 24-hour urine albumin greater than 300 mg.
Insulin requirements greater than 0.8 units/kg/day.
Hypoglycemia unawareness: Unless easily corrected via simple modifications in the patient's diabetes regimen, the potential enrollee will be excluded if he/she has suffered greater than or equal to 2 episodes of severe hypoglycemia during the most recent 12 months, defined as requiring assistance from a third party, receiving assistance from medics, visiting an ER or being hospitalized due to the hypoglycemia.
Evidence of chronic infection.
History of any malignancy.
Any chronic medical condition that unduly increase risk for the potential enrollee as judged by study investigators.
Hematologic abnormalities:
Hypertension, whether untreated or resistant to medical treatment, with blood pressure greater than 140/85 mm Hg.
Pregnancy, breastfeeding or planned pregnancy within two years.
Unable to identify primary care provider willing to partner with study investigators.
Contacts and Locations More Information
| Responsible Party: | ( Amylin Pharmaceuticals ) |
| Study ID Numbers: | 030245, 03-DK-0245 |
| Study First Received: | July 10, 2003 |
| Last Updated: | January 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00064714 History of Changes |
| Health Authority: | United States: Federal Government |
|
Type 1 Diabetes Mellitus (T1DM) Beta-Cell C-Peptide Immunosuppression Insulin Islet |
Function AC2993 (Synthetic Exendin-4) Diabetes Mellitus Type I Diabetes Mellitus T1DM |
|
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Exenatide Immune System Diseases Diabetes Mellitus, Type 1 |
Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |
