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The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes
Lead sponsor
Asset
Pramlintide
Amylin analog
Listed sites
1
Recruiting sites
—
Enrollment
20
Study population
Type 1 diabetes
Key I/E criteria
•HbA1c ≤8.5%•Healthy volunteers
Primary endpoint
•Area under the curve for glucose
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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. -
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
1 endpointArea under the curve for glucose
descriptive, improvement
Other (unclassified)
1 endpointglucagon and gastric emptying
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.