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Closedloop

CompletedPhase 1

Closed Loop System With Pramlintide Versus Exenatide

CLOSED LOOP SYSTEM IN TYPE 1 DIABETES MANAGEMENT COMPARISON WITH PRAMLINTIDE Vs EXENATIDE

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

NCT IDNCT01269008
Org study ID2010 -434

Timeline

Milestones

Study first posted2011-01-04estimated
Last update posted2018-02-20actual
Study start2010-12 (month precision)
Primary completion2013-01actual (month precision)
Study completion2013-01actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age30 Years
SexAll
Healthy volunteersNot accepted

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 endpoint
Primary/protocol endpoint

Better 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

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.