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CompletedPhase 3

The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes

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

NCT IDNCT00206297
Org study IDH-14358

Timeline

Milestones

Study first posted2005-09-21estimated
Last update posted2016-07-14estimated
Study start2003-10 (month precision)
Study completion2006-02 (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age21 Years
SexAll
Healthy volunteersAccepted

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
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Area under the curve for glucose

descriptive, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

glucagon and gastric emptying

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.