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CompletedPhase 4

A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

A Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Pramlintide Acetate When Administered by Subcutaneous Infusion in a Basal-Bolus Manner as an Adjunct to Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

Enrollment

12

actual

Study population

Type 1 diabetes

Key I/E criteria

BMI ≤35HbA1c 7-10%

Primary endpoint

Fasting and postprandial pramlintide pharmacokinetics

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 IDNCT00502138
Org study IDPramlintide Infusion in IDDM

Timeline

Milestones

Study first posted2007-07-17estimated
Last update posted2013-01-16estimated
Study start2007-07 (month precision)
Primary completion2008-01actual (month precision)
Study completion2008-01actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Type 1 diabetes of at least one year duration;

2. Treated with CSII therapy for at least 6 months;

3. Age 18 to 70 years, inclusive;

4. A1C >7.0 and ≤10% as screening;

5. BMI ≤35 kg/m2;

6. Stable insulin dose (±10%) for at least 3 months prior to screening;

7. If female, has a negative urine pregnancy test at screening;

8. If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study;

9. Able to understand and sign the required study documents and comply with the protocol requirements

Exclusion criteria

1. Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator;

2. Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being;

3. If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant;

4. Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months;

5. Has a history of hypoglycemia unawareness;

6. Has a confirmed diagnosis of gastroparesis;

7. Requires the use of drugs that stimulate gastrointestinal motility;

8. Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids);

9. Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit;

10. Has been treated with pramlintide within 3 months of screening visit;

11. Has received an investigational drug within 3 month of screening visit;

12. Is currently participating in a clinical trial

Endpoints (3)

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
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Hemoglobin A1c

Time frame:16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Fasting and postprandial pramlintide pharmacokinetics

Time frame:Four months

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction

Time frame:four months

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.