TerminatedPhase NAResults posted

Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port

A Randomized, Parallel, Single Center, Comparison, Pilot Study Evaluating the Safety and Efficacy of Using Symlin Alongside Insulin in a Multiple Injection Port (I-PORT)

Lead sponsor

Texas Diabetes & Endocrinology, P.A.

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes, Type 2 diabetes

Eligibility highlights

•HbA1c 6.5-9%

Primary endpoint

•HbA1c, change

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 IDNCT00790699

Org study IDTDE 001

Timeline

Milestones

Study first posted2008-11-13estimated

Last update posted2020-10-20actual

Results first posted2020-10-20actual

Study start2009-08 (month precision)

Primary completion2011-11actual (month precision)

Study completion2011-11actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Type 1 diabetesType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•male or female ages 18 and up

•utilizing a regimen of at least two injections daily of insulin and at least two injections daily of Symlin

•able to understand and sign an informed consent form and HIPPA form

•agrees to all study visits and procedures

•HbA1c between >6.5 and <9.0 (inclusive)

Exclusion criteria

•history or current diagnosis of chronic disease which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study

•history of malignancy with in the last five years of study entry (other than basal cell carcinoma)

•current use of any drugs that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine), agents that slow intestinal absorption of nutrients (e.g. a-glucosidase inhibitors) or promotility agents (e.g. metaclopromide)

•any contraindication of Symlin or I-PORT according to the package labeling

•are female and pregnant, lactating or planning to become pregnant during the duration of the trial

•are poorly compliant with their current insulin and/or Symlin regimen, as defined by their HCP

•has history of known hypersensitivity to plastics or polymers

•treatment with any investigational drug within one month prior to enrollment

•myocardial infarction or stroke within six months prior to screening

•initiated use of Symlin pen or any Insulin pen in lieu of a vial in last 4 weeks (pen use is okay as long as they have been using it for at least 4 weeks prior to screening visit)

•female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, double barrier methods, Intrauterine devices, surgical sterilization or vasectomized partner)

•have confirmed diagnosis of gastroparesis

•have hypoglycemia unawareness

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

Patient-reported / QoL

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.

Time frame:3 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · % of HbA1c	95% CI
I-PORTScreening	7.68	-
Month 3	7.34	-
Baseline	7.66	-
Standard InjectionsScreening	7.93	-
Month 3	7.42	-
Baseline	7.70	-

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).

Time frame:3 months

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
Visit 1Treatment Satisfaction Control	66.07	-
Treatment Satisfaction Treatment	67.16	-
DTSQ Control	37.46	-
DTSQ Treatment	35.41	-
Diabetes Distress Scale Control	38.20	-
Diabetes Distress Scale Treatment	34.00	-
Visit 6Treatment Satisfaction Control	65.66	-
Treatment Satisfaction Treatment	54.28	-
DTSQ Control	34.54	-
DTSQ Treatment	33.25	-
Diabetes Distress Scale Control	33.86	-
Diabetes Distress Scale Treatment	31.45	-

p>.05RM-ANOVA

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.