UnknownPhase 1

Safety and Efficacy of BC LisPram

A Randomized Controlled Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics, and Closed-loop Efficacy of BC LisPram Compared to Rapid Insulin in Pump-treated Adults With Type 1 Diabetes

Lead sponsor

Michael Tsoukas

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c ≤9.5%

Primary endpoints

•Pharmacokinetics of Pramlintide•Pharmacokinetics of Insulin•Pharmacokinetics of Paracetamol

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 IDNCT04972175

Org study ID2021-00050920

Secondary IDPro00050920Research Ethics Board - Advarra

Timeline

Milestones

Study first posted2021-07-22actual

Study start2021-07-28actual

Last update posted2022-02-16actual

Primary completion2022-06estimated (month precision)

Study completion2022-06estimated (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

•Males and females ≥ 18 years of age.

•Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

•Insulin pump therapy for at least 3 months, with daily insulin needs ranging between 30 and 80 U.

•Most recent HbA1c ≤ 9.5% (over the last two months).

•Effective birth control in female participants of childbearing potential. Medically acceptable contraception methods include condom, pills, and intrauterine device.

Exclusion criteria

•Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc....).

•Current use of glucocorticoid medication.

•Use of medication that alters gastrointestinal motility.

•Planned or ongoing pregnancy.

•Breastfeeding individuals

•Severe hypoglycemic episode within one month of admission.

•Severe diabetic ketoacidosis episode within one month of admission.

•Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.

•Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

•Known hypersensitivity to any of the study drugs or their excipients.

•Allergy to paracetamol (acetaminophen).

•Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

•Clinically abnormal significant values for haemato, biochemistry, or urinalysis screening test as judged by the Principle Investigator for underlying disease.

•Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Endpoints (9)

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

Safety / tolerability / PK

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Glucose Pharmacodynamics

Time frame:Breakfast, lunch and dinner from 0 to 4 hours

descriptive, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Pharmacokinetics of Pramlintide

Time frame:Breakfast, lunch, dinner from 0 to 4 hours

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics of Insulin

Time frame:Breakfast, lunch, dinner from 0 to 4 hours

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics of Paracetamol

Time frame:Breakfast and dinner from 0 to 4 hours

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Hypoglycaemic episodes

Time frame:0 to 50 hours

Documented hypoglycemia

event count, event

Primary/protocol endpoint

Gastrointestinal symptoms

Time frame:0 to 50 hours

event count, event

Primary/protocol endpoint

Local tolerability at pump injection site

Time frame:0 to 50 hours

descriptive, event

Primary/protocol endpoint

Incidence of adverse event

Time frame:0 to 50 hours

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Glucagon Pharmacodynamics

Time frame:Breakfast and dinner from 0 to 4 hours

concentration, descriptive

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.