DelfaGLP-1 Atlas

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CompletedPhase 4

Continuous Subcutaneous Infusion of Pramlintide and Insulin

Continuous Subcutaneous Infusion of Pramlintide and Insulin: A Randomized, Crossover Design Study

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

13

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤8.5%

Primary endpoint

•Postprandial 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 IDNCT00291772
Org study IDH-17339

Timeline

Milestones

Study first posted2006-02-15estimated
Last update posted2016-07-14estimated
Study start2006-01 (month precision)
Primary completion2007-11actual (month precision)
Study completion2007-11actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age13 Years
Maximum age22 Years
SexAll
Healthy volunteersNot accepted

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. -

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

Time frame:4 hrs

Postprandial glucose

descriptive, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

glucagon and gastric emptying

Time frame:4 hrs

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.