Closed Loop System With Pramlintide Versus Exenatide

NCT01269008 | Completed Phase 1

• 1 other identifier: 2010 -434
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Closed loop; type 1 diabetes; Symlin; Byetta; diabetes; insulin; insulin pump

Outcome Measures

Primary Outcomes (1)

• Better meal and post meal sugars on the closed loop device using the study medications.

  We will assess the preliminary data collected from the subjects enrolled by that time

  18 months

Interventions

Medtronic ePID 2.0 DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Albert Einstein College of Medicine CRC

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Rubina A Heptulla, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Endocrinology & Diabetes

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 20, 2018

Record last verified: 2018-02

Locations

US (1)