Safety and Efficacy of BC LisPram

NCT ID: NCT04972175

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2022-06-30

Brief Summary

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.

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.

Conditions

Type1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapid Insulin lispro - Conventional bolus

Participants will use subcutaneously-delivered rapid insulin (lispro) through pump therapy.

Group Type: ACTIVE_COMPARATOR

50-Hour Intervention - Rapid Insulin lispro

Intervention Type: DRUG

Subcutaneous-delivery of insulin lispro using pump therapy.

BC LisPram - Conventional bolus

Participants will use subcutaneously-delivered BC LisPram through pump therapy.

Group Type: EXPERIMENTAL

50-Hour Intervention - BC LisPram

Intervention Type: DRUG

Subcutaneous-delivery of BC LisPram using pump therapy.

BC LisPram - Dual wave bolus

Participants will use subcutaneously-delivered BC LisPram through pump therapy. During dual wave bolusing, 50% of the prandial bolus is delivered immediately, and the other 50% delivered over the next 30 minutes.

Group Type: EXPERIMENTAL

50-Hour Intervention - BC LisPram

Intervention Type: DRUG

Subcutaneous-delivery of BC LisPram using pump therapy.

Interventions

50-Hour Intervention - Rapid Insulin lispro

Subcutaneous-delivery of insulin lispro using pump therapy.

Intervention Type: DRUG

50-Hour Intervention - BC LisPram

Subcutaneous-delivery of BC LisPram using pump therapy.

Intervention Type: DRUG

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adocia

INDUSTRY

Sponsor Role: collaborator

Michael Tsoukas

NETWORK

Sponsor Role: lead

Responsible Party

Michael Tsoukas

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Tsoukas, MD

Role: PRINCIPAL_INVESTIGATOR

Applied Medical Informatics Research Inc.

Locations

Hygea Medical Clinic

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alexia Macina

Role: CONTACT

alexia.macina@affiliate.mcgill.ca

+1 514-623-2520

Facility Contacts

Louise Ullyatt

Role: primary

louise@cmhygea.com

5149380995

Other Identifiers

Pro00050920

Identifier Type: OTHER

Identifier Source: secondary_id

2021-00050920

Identifier Type: -

Identifier Source: org_study_id