The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes

NCT00206297 | Completed Phase 3

• 1 other identifier: H-14358
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a very low steady dose) for several hours

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; hypoglycemia; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Area under the curve for glucose

Secondary Outcomes (1)

• glucagon and gastric emptying

Interventions

Pramlintide DRUG

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Twenty (20) children with T1DM will be recruited for these studies. These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be:
• Between 12-21 years of age at the time of enrollment.
• Have been diagnosed with diabetes for at least 2 years 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 their T1DM and treated hypothyroidism.
• Menstruating women must have a negative pregnancy test.
• Hemoglobin equal to or \> 12 g/dL before each study.
• Weight more than 44 kg. -

You may not qualify if:

• Age greater than 22 years or less than 12 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 or equal to 8.5 % in a diabetic subject
• BMI \> 90 % tile for age or \< 10 % tile for age
• Weight less than 44 kg. -

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Interventions

pramlintide

Condition Hierarchy (Ancestors)

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

Study Officials

• Rubina Heptulla, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2003
• Study Completion: February 1, 2006
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (1)