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Closedloop
CompletedPhase 1Closed Loop System With Pramlintide Versus Exenatide
CLOSED LOOP SYSTEM IN TYPE 1 DIABETES MANAGEMENT COMPARISON WITH PRAMLINTIDE Vs EXENATIDE
Lead sponsor
Assets
Exenatide / Pramlintide
Listed sites
1
Recruiting sites
—
Enrollment
13
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age greater than 18 years and less than 30 years.
2. Have had diabetes for at least 1 year, and in good control (HbA1C less than 8.5 %).
3. Be on continuous subcutaneous insulin infusion using an insulin pump
4. Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if present
5. Menstruating women must have negative pregnancy test.
6. Hemoglobin (Hb) more than 12 g/dl
7. Weight must be equal to or greater than 50 Kg
Exclusion criteria
1. 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).
2. Hemoglobin less than 12 g/dl
3. Lack of a supportive family environment
4. Positive pregnancy test based on serum beta HCG in menstruating young women
5. Evidence or history of chemical abuse
6. HbA1c more than 8.5 %
7. Weight less than 50 Kg
8. History of gastroparesis and on medications that alter gastric emptying
9. History of Pancreatitis and impaired renal function
10. Hypoglycemic unawareness
11. History of sensitivity to 5-HT3 receptor antagonists
12. History of QT prolongation
13. Concomitant use of both Acetaminophen and vitamin C
14. Patients on glucocorticoid therapy
15. Known allergies to any of the study medication
Endpoints (1)
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
1 endpointBetter meal and post meal sugars on the closed loop device using the study medications.
Time frame:18 months
Postprandial glucose
descriptive, improvement
Publications (3)
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
- Journal of controlled release : official journal of the Controlled Release Society2022 Dec (month)PMID36374646doi:10.1016/j.jconrel.2022.10.039via pubmed acronym asset candidate
- Nature communications2017 Nov 24PMID29176623doi:10.1038/s41467-017-01764-1via pubmed acronym asset candidate
- Journal of diabetes science and technology2014 Sep (month)PMID25030181doi:10.1177/1932296814542153via pubmed acronym asset candidate
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.