Skip to main content
Delfa

← All trials/NCT00460304

CompletedPhase NA

The Effect of Pramlintide on Meal Time Insulin Bolus

Asset

Pramlintide

Amylin analog

Listed sites

0

Recruiting sites

-

Estimated enrollment

12

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c ≤8.9%

Primary endpoint

•Mean ICR from Vist 3a-e and 4a-e will be compared. Percentage reduction of ICR

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00460304
Org study ID07-01

Timeline

Milestones

Study first posted2007-04-13estimated
Last update posted2009-04-03estimated
Study start2007-09 (month precision)
Primary completion2008-11actual (month precision)
Study completion2008-11actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age: >17
•Type I diabetes
•Onset of diabetes >3 months
•Use of insulin pump >3 months
•Hb A1C <8.9%
•Demonstrated compliance to clinic visits
•Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter
•Monitor blood glucose >4/day

Exclusion criteria

•Pregnancy or nursing
•Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc.
•Renal failure (creatinine >1.5 mg/dl
•Symptomatic gastroparesis
•Using a medication that would interfere with insulin sensitivity
•Treatment with extenatide or DPP IV inhibitor within the last 4 weeks
•HbA1C change >0.9 % within the last 3 months
•Significant change in eating or activity pattern
•Weight change of >1.9 kg within the last 3 months
•ALT >3 times upper limits of normal

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

Glycemic / diabetes
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

The mean post-meal glucose from the four hour period after beginning a meal will be averaged for each bolus wave form. Then the three wave form mean glucose results will be compared.

Time frame:12-10-07

Postprandial glucose

descriptive, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

The mean ICR from Vist 3a-e and 4a-e will be compared. Percentage reduction of ICR will be calculated. From these the mean ICR will be calculated.

Time frame:12-10-07

descriptive

Publications (8)

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 6, 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 6, 2026 snapshot.