Continuous Subcutaneous Infusion of Pramlintide and Insulin - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00291772

Purpose

The purpose of this study is to see if giving the study drug in a slow and steady dose will lower blood sugars during the meal and after-meal time.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: Pramlintide	Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Pramlintide Pramlintide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Continuous Subcutaneous Infusion of Pramlintide and Insulin: A Randomized, Crossover Design Study

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Area under the curve for glucose [ Time Frame: 4 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

glucagon and gastric emptying [ Time Frame: 4 hrs ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	January 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Basal and bolus pramlintide subcutaneous infusion

Detailed Description:

The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term health problems. Insulin management is aimed to control blood sugar as near to normal as safely possible. However, the possibility of low blood sugars still remains. Low blood sugars the major limiting factor in gaining "tight" control of blood sugar. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. There is a lack of insulin and failure of glucagon to work correctly in diabetes. This leads to high blood sugars right after a meal.

It is very difficult to have normal blood sugars when someone has diabetes. This may be due to another hormone called amylin. This hormone may be too low in people with Type 1 diabetes. Amylin is made in the pancreas (the part of the body that makes insulin). Amylin works by lowering blood sugars after a meal. Pramlintide is the name of the study drug. It is the man-made form of amylin. It is given as a shot (under the skin) like insulin. Pramlintide has been FDA approved.

Studies in adults have shown that amylin lowers the high levels of glucagon made after a meal. This results in improved "after meal" high blood sugars and overall blood sugar control. Currently, the drug is given as a separate shot from insulin. When given as a shot (one dose shot given all at once) to children and young adults, it seems to cause low blood sugars right after a meal. The "slowing down" of food digestion may be the cause of the low blood sugars with pramlintide use. Another possible cause of the low blood sugars may be the way drug is being given (instant shot versus a slow infusion through a pump).

Eligibility

Ages Eligible for Study:	13 Years to 22 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be

13-22 years of age at the time of enrollment.
Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%).
Be on continuous subcutaneous insulin infusion using an insulin pump.
Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
Menstruating women must have a negative pregnancy test.
Hemoglobin equal to or greater than 12 g/dL before each study.
Weight more than 44 kg. -

Exclusion Criteria:

Age greater than 23 years or less than 13 years at the time of study
Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications
Anemia (hemoglobin less than 12mg/dl)
Lack of a supportive family environment
Positive pregnancy test in menstruating young women
Evidence or history of chemical abuse
Hgb A1C greater than 8.5 % in a diabetic subject
BMI > 90 % tile for age or < 10 % tile for age
Weight less than 44 kg. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291772

Locations

United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Rubina Heptulla, MD

Baylor College of Medicine

More Information

Publications of Results:

Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7.

Responsible Party:	Baylor College of Medicine ( Rubina Heptulla, MD )
Study ID Numbers:	H-17339
Study First Received:	February 13, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00291772
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Type 1 Diabetes
hypoglycemia
hyperglycemia

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Pramlintide
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009