Closed Loop System With Pramlintide Versus Exenatide (Closedloop)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01269008
First received: December 29, 2010
Last updated: January 23, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Device: Medtronic ePID 2.0
    Closed loop system is an automated insulin delivery system based on body blood sugar. It consists of an Insulin pump, glucose sensor, and a device presently a laptop with all the algorithms.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 18 years and less than 30 years.
  2. Have had diabetes for at least 1 year, and in good control (HbA1C less than 8.5 %).
  3. Be on continuous subcutaneous insulin infusion using an insulin pump
  4. Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if present
  5. Menstruating women must have negative pregnancy test.
  6. Hemoglobin (Hb) more than 12 g/dl
  7. Weight must be equal to or greater than 50 Kg

Exclusion Criteria:

  1. 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).
  2. Hemoglobin less than 12 g/dl
  3. Lack of a supportive family environment
  4. Positive pregnancy test based on serum beta HCG in menstruating young women
  5. Evidence or history of chemical abuse
  6. HbA1c more than 8.5 %
  7. Weight less than 50 Kg
  8. History of gastroparesis and on medications that alter gastric emptying
  9. History of Pancreatitis and impaired renal function
  10. Hypoglycemic unawareness
  11. History of sensitivity to 5-HT3 receptor antagonists
  12. History of QT prolongation
  13. Concomitant use of both Acetaminophen and vitamin C
  14. Patients on glucocorticoid therapy
  15. Known allergies to any of the study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269008

Locations
United States, New York
Albert Einstein College of Medicine CRC
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
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 July 24, 2014