DelfaGLP-1 Atlas

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WithdrawnPhase 4

Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

The Pilot Study:Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

—

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT00505882
Org study ID032007-054

Timeline

Milestones

Study first posted2007-07-25estimated
Last update posted2019-01-08actual
Study start2007-07 (month precision)
Primary completion2008-12estimated (month precision)
Study completion2008-12estimated (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•12 to 40 years old
•Type 1 diabetes
•Fasting C-peptide ≤ 1.0 ng/ml
•Early diagnosed type 1 diabetes. (<6 months since diagnosis of type 1 diabetes.)
•HbA1c greater than 7.0 %
•Male, or If female, is nonlactating and has a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) at Visit 1 (screening).

Exclusion criteria

•Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
–Hepatic disease
–Gastrointestinal disease
–Haematologic disorder
–Cardiovascular disorder
–Organ transplantation
–Hemochromatosis
–HIV, HBV, or HCV infection
•Abuses drugs or alcohol or has a history of abuse
•Eating disorder
•Has donated blood within 60 days
•Has had major surgery or a blood transfusion within 2 months
•Usage of medications that affect weight changes
•Use of medications that affect gastrointestinal motility
•Usage of medications that affect glucose/insulin metabolism
•Received any study medication or has participated in any type of clinical trial within 30 days prior to screening.
•Has known allergies or hypersensitivity to any component of study treatment.

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

Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

The change in weight (kg) will be compared between as well as within the placebo and the pramlintide treatment group from baseline to the end of the study.

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

mixed meal tolerance test-the C-peptide area under the curve The HOMA R and McAuley's index HbA1c The event rate of severe hypoglycemia Waist circumference Cardio C-reactive protein level DQOL Safety parameter

Time frame:6 months

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.