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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
Lead sponsor
Asset
Pramlintide
Subcutaneous · Amylin analog
Listed sites
1
Recruiting sites
—
Enrollment
12
actual
Study population
Type 1 diabetes
Key I/E criteria
•BMI ≤35•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointHemoglobin A1c
Time frame:16 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Safety / tolerability / PK
1 endpointFasting and postprandial pramlintide pharmacokinetics
Time frame:Four months
concentration, descriptive
Other (unclassified)
1 endpointHemoglobin 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
- Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2009 Nov-Dec (year)PMID19546056doi:10.4158/EP09044.ORR1via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.