Current partner codePEPTIDESDE
NCT04972175·Phase 1·INTERVENTIONAL

Safety and Efficacy of BC LisPram

Status

Unknown

Phase

Phase 1

Enrollment

16

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.

Full detailed description

Subjects will be randomized to intervention sequences. The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus). The following 10 participants will be randomly allocated to a sequence of either two or three treatments. Each treatment period will last 50 hours. PK/PD assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment.

Interventions

Treatment arms and agents.

DRUG

50-Hour Intervention - Rapid Insulin lispro

Subcutaneous-delivery of insulin lispro using pump therapy.

DRUG

50-Hour Intervention - BC LisPram

Subcutaneous-delivery of BC LisPram using pump therapy.

Timeline

From registration to results.

  1. First posted

    Jul 22, 2021

  2. Study start

    Jul 28, 2021

  3. Primary completion

    Jun 2022

  4. Study completion

    Jun 2022

  5. Results posted

    Not reported

  6. Registry updated

    Feb 16, 2022

Outcomes

What the study measures.

Primary outcomes

Pharmacokinetics of Pramlintide

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

Area under the pramlintide concentration-time curve

Pharmacokinetics of Insulin

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

Area under the insulin concentration-time curve

Pharmacokinetics of Paracetamol

Time frame · Breakfast and dinner from 0 to 4 hours

Area under the paracetamol concentration-time curve

Glucose Pharmacodynamics

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

Area under the sensor glucose concentration-time curve

Glucagon Pharmacodynamics

Time frame · Breakfast and dinner from 0 to 4 hours

Area under the plasma glucagon concentration-time curve

Hypoglycaemic episodes

Time frame · 0 to 50 hours

Number of hypoglycaemic episodes during the 0 to 50 hour period.

Gastrointestinal symptoms

Time frame · 0 to 50 hours

Frequency of gastrointestinal symptoms during the 0 to 50 hour period.

Local tolerability at pump injection site

Time frame · 0 to 50 hours

Local tolerability at pump injection site during the 0 to 50 hour period.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.).

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Hygea Medical Clinic

Montreal, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.