Diabetes Mellitus Clinical Trial
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
| Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
| Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
| Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
| Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
| Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
| Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
| Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
| Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |