DelfaGLP-1 Atlas

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CompletedPhase 3

The Role of Amylin and Glucagon in T1DM

The Role of Amylin and Glucagon in the Management of Normalizing Glucose Excursions in Children With Type 1 Diabetes

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

30

Study population

Type 1 diabetes

Key I/E criteria

•HbA1c ≤8%•Healthy volunteers

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 IDNCT00206258
Org study IDH-11741

Timeline

Milestones

Study first posted2005-09-21estimated
Last update posted2016-07-14estimated
Study start2002-07 (month precision)
Study completion2005-08 (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age21 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Age >12 years < 19 years

2. Have diabetes for at least 2 years and in good control (HbA1C < 8%).

3. Be on continuous subcutaneous insulin infusion using an insulin pump.

4. Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism.

5. Menstruating women must have negative pregnancy test.

6. Hemoglobin equal to or > than 12 g/dL before each study.

7. Weight more than 44 kg.

Exclusion criteria

1. Age >18 or < 12 y at the time of study

2. Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis

3. Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies)

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 >8.0 % in a diabetic subject

8. BMI > 90 % tile for age or < 10 % tile for age

9. Allergy to local anesthetics (ELAMAX Cream)

10. Weight less than 44 kg

11. Children of staff members

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

Postprandial glucose

concentration, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Glucagon and gastric emptying

descriptive

Publications (1)

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.