Closed Loop System With Pramlintide Versus Exenatide (Closedloop)
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Purpose
Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting insulin therapy. Furthermore, this occurs even in the setting of the closed loop system. Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes, there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial hyperglycemia in diabetes. With this protocol, the investigators would like to optimize treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the process also optimize the insulin algorithm.
This is a paired, randomized, and controlled comparison of pramlintide and insulin versus exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin delivery.
The investigators will stratify the study subjects into the following sub-groups of 5 subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old. The investigators would also begin the study with the 21-25 year patient sub-group and then transition to the other sub-groups after evaluating all the safety issues. 22-30 year old ones would be considered as an adult subset, 18-21 year olds would be considered pediatric subset according to the guidelines of FDA's Center for Devices and Radiological Health (CDRH) and 16-18 year olds are considered typical pediatric population. At this time, Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not have any literature in Spanish that may used in explaining the study to this group of patients. When in the future Medtronic is able to provide us with the appropriate Spanish literature, the investigators will at that time amend the protocol to include this group of subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Device: Medtronic ePID 2.0 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CLOSED LOOP SYSTEM IN TYPE 1 DIABETES MANAGEMENT COMPARISON WITH PRAMLINTIDE Vs EXENATIDE |
- Better meal and post meal sugars on the closed loop device using the study medications. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]We will assess the preliminary data collected from the subjects enrolled by that time
| Enrollment: | 13 |
| Study Start Date: | December 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
-
Device: Medtronic ePID 2.0
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than 18 years and less than 30 years.
- Have had diabetes for at least 1 year, and in good control (HbA1C less than 8.5 %).
- Be on continuous subcutaneous insulin infusion using an insulin pump
- Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if present
- Menstruating women must have negative pregnancy test.
- Hemoglobin (Hb) more than 12 g/dl
- Weight must be equal to or greater than 50 Kg
Exclusion Criteria:
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis).
- Hemoglobin less than 12 g/dl
- Lack of a supportive family environment
- Positive pregnancy test based on serum beta HCG in menstruating young women
- Evidence or history of chemical abuse
- HbA1c more than 8.5 %
- Weight less than 50 Kg
- History of gastroparesis and on medications that alter gastric emptying
- History of Pancreatitis and impaired renal function
- Hypoglycemic unawareness
- History of sensitivity to 5-HT3 receptor antagonists
- History of QT prolongation
- Concomitant use of both Acetaminophen and vitamin C
- Patients on glucocorticoid therapy
- Known allergies to any of the study medication
Contacts and Locations| United States, New York | |
| Albert Einstein College of Medicine CRC | |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: | Rubina A Heptulla, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
No publications provided
| Responsible Party: | Rubina Heptulla, Division Chief of Pediatric Endocrinology & Diabetes, Albert Einstein College of Medicine of Yeshiva University |
| ClinicalTrials.gov Identifier: | NCT01269008 History of Changes |
| Other Study ID Numbers: | 2010 -434 |
| Study First Received: | December 29, 2010 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
|
Closed loop type 1 diabetes Symlin Byetta |
diabetes insulin insulin pump |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Exenatide Pramlintide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013