GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus

Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus.

Lead sponsor

Montefiore Medical Center

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

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 IDNCT00442767

Org study IDH-18629

Secondary IDGCRC protocol #:0954

Timeline

Milestones

Study first posted2007-03-02estimated

Last update posted2018-07-10actual

Results first posted2018-07-10actual

Study start2007-02 (month precision)

Primary completion2009-02actual (month precision)

Study completion2009-02actual (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 volunteersNot accepted

Inclusion criteria

•Type 1 diabetes only

•Diagnosed with T1DM for at least 1 year

•HbA1C less than or equal to 8.5%

•Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump

•Hemoglobin equal to or greater than 12mg/dL

•Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism

•Negative pregnancy test, in the case of females

Exclusion criteria

•Lack of supportive family

•Evidence or history of chemical abuse

•BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age

•Patient who is poorly compliant with current insulin management and/or Prescribed self blood glucose monitoring

•Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months

•Have hypoglycemia unawareness

•Have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility

•Pregnant or lactating patients, or patients planning on becoming pregnant

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.

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone

Time frame:0 to 240 minutes post-dose

Postprandial glucose

concentration, improvement

Posted result

Group	Value (mean), mmol*L/min	95% CI
Rapid Acting Insulin Therapy - Before Meal	205	—
Pre-meal Pramlintide and Post-meal Insulin Therapy	993	—

Secondary/protocol endpoint

Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.

Time frame:0 to 120 minutes post-dose

concentration, descriptive

Posted result

Group	Value (mean), ng*L/min	95% CI
Rapid Acting Insulin Therapy - Before Meal	6060	—
Pre-meal Pramlintide and Post-meal Insulin Therapy	7575	—

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

Reducing postprandial hyperglycemia with adjuvant premeal pramlintide and postmeal insulin in children with type 1 diabetes mellitus.
Pediatric diabetes2009 Jun (month)PMID19140902doi:10.1111/j.1399-5448.2008.00490.xvia CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.