Safety and Efficacy of BC LisPram

Type1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972175
• Other study ID #: 2021-00050920
• Secondary ID: Pro00050920
• Status: Recruiting
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: June 2022

Study information

• Verified date: February 2022
• Source: Applied Medical Informatics Research Inc.
• Contact: Alexia Macina
• Phone: +1 514-623-2520
• Email: alexia.macina[@]affiliate.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Drug:
• 50-Hour Intervention - Rapid Insulin lispro
Subcutaneous-delivery of insulin lispro using pump therapy.
• 50-Hour Intervention - BC LisPram
Subcutaneous-delivery of BC LisPram using pump therapy.

Locations

Country	Name	City	State
Canada	Hygea Medical Clinic	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Michael Tsoukas	Adocia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Pramlintide	Area under the pramlintide concentration-time curve	Breakfast, lunch, dinner from 0 to 4 hours
Primary	Pharmacokinetics of Insulin	Area under the insulin concentration-time curve	Breakfast, lunch, dinner from 0 to 4 hours
Primary	Pharmacokinetics of Paracetamol	Area under the paracetamol concentration-time curve	Breakfast and dinner from 0 to 4 hours
Primary	Glucose Pharmacodynamics	Area under the sensor glucose concentration-time curve	Breakfast, lunch and dinner from 0 to 4 hours
Primary	Glucagon Pharmacodynamics	Area under the plasma glucagon concentration-time curve	Breakfast and dinner from 0 to 4 hours
Primary	Hypoglycaemic episodes	Number of hypoglycaemic episodes during the 0 to 50 hour period.	0 to 50 hours
Primary	Gastrointestinal symptoms	Frequency of gastrointestinal symptoms during the 0 to 50 hour period.	0 to 50 hours
Primary	Local tolerability at pump injection site	Local tolerability at pump injection site during the 0 to 50 hour period.	0 to 50 hours
Primary	Incidence of adverse event	Number of adverse events during the 0 to 50 hour period.	0 to 50 hours