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Trial · Interventional

CompletedPhase 3Registry data

The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes

NCTNCT00206297 (opens ClinicalTrials.gov in a new tab)Other idH-14358
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
20 participants
Sponsor
Baylor College of Medicine · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2003
Primary completion
Not stated
Completion
Feb 2006
First posted
21 Sept 2005 (estimated)
Last update posted
14 Jul 2016 (estimated)
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20032004200520062007
  1. Ph 3

    The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes

    NCT00206297

    Oct 2003 to Feb 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PramlintideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the curve for glucose

Secondary outcomes(1)

  1. glucagon and gastric emptying

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 21 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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: 1. Between 12-21 years of age at the time of enrollment. 2. Have been diagnosed with diabetes for at least 2 years 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 their T1DM and treated hypothyroidism. 5. Menstruating women must have a negative pregnancy test. 6. Hemoglobin equal to or \> 12 g/dL before each study. 7. Weight more than 44 kg. - Exclusion Criteria: 1. Age greater than 22 years or less than 12 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 or equal to 8.5 % in a diabetic subject 8. BMI \> 90 % tile for age or \< 10 % tile for age 9. Weight less than 44 kg. -

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