Continuous Subcutaneous Infusion of Pramlintide and Insulin

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00291772
First received: February 13, 2006
Last updated: July 16, 2008
Last verified: July 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Subcutaneous Infusion of Pramlintide and Insulin: A Randomized, Crossover Design Study

Resource links provided by NLM:


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:
    Drug: Pramlintide
    Basal and bolus pramlintide subcutaneous infusion
    Other Name: Symlin
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

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

Exclusion Criteria:

  1. Age greater than 23 years or less than 13 years at the time of study
  2. 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
  3. Anemia (hemoglobin less than 12mg/dl)
  4. Lack of a supportive family environment
  5. Positive pregnancy test in menstruating young women
  6. Evidence or history of chemical abuse
  7. Hgb A1C greater than 8.5 % in a diabetic subject
  8. BMI > 90 % tile for age or < 10 % tile for age
  9. Weight less than 44 kg. -
  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: 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rubina Heptulla, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00291772     History of Changes
Other Study ID Numbers: H-17339
Study First Received: February 13, 2006
Last Updated: July 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Type 1 Diabetes
hypoglycemia
hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Pramlintide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014