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Safety and Efficacy of BC LisPram

Primary Purpose

Type1 Diabetes Mellitus

Status

Recruiting

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

50-Hour Intervention - Rapid Insulin lispro

50-Hour Intervention - BC LisPram

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus focused on measuring Pramlintide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

Hygea Medical ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Rapid Insulin lispro - Conventional bolus

BC LisPram - Conventional bolus

BC LisPram - Dual wave bolus

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Pharmacokinetics of Pramlintide

Area under the pramlintide concentration-time curve

Pharmacokinetics of Insulin

Area under the insulin concentration-time curve

Pharmacokinetics of Paracetamol

Area under the paracetamol concentration-time curve

Glucose Pharmacodynamics

Area under the sensor glucose concentration-time curve

Glucagon Pharmacodynamics

Area under the plasma glucagon concentration-time curve

Hypoglycaemic episodes

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

Gastrointestinal symptoms

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

Local tolerability at pump injection site

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

Incidence of adverse event

Number of adverse events during the 0 to 50 hour period.

Secondary Outcome Measures

Full Information

NCT ID

NCT04972175

First Posted

July 15, 2021

Last Updated

February 14, 2022

Sponsor

Michael Tsoukas

Collaborators

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT04972175

Brief Title

Safety and Efficacy of BC LisPram

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2021 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Tsoukas

Collaborators

Adocia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

Keywords

Pramlintide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rapid Insulin lispro - Conventional bolus

Arm Type

Active Comparator

Arm Description

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

Arm Title

BC LisPram - Conventional bolus

Arm Type

Experimental

Arm Description

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

Arm Title

BC LisPram - Dual wave bolus

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

50-Hour Intervention - Rapid Insulin lispro

Intervention Description

Subcutaneous-delivery of insulin lispro using pump therapy.

Intervention Type

Drug

Intervention Name(s)

50-Hour Intervention - BC LisPram

Intervention Description

Subcutaneous-delivery of BC LisPram using pump therapy.

Primary Outcome Measure Information:

Title

Pharmacokinetics of Pramlintide

Description

Area under the pramlintide concentration-time curve

Time Frame

Breakfast, lunch, dinner from 0 to 4 hours

Title

Pharmacokinetics of Insulin

Description

Area under the insulin concentration-time curve

Time Frame

Breakfast, lunch, dinner from 0 to 4 hours

Title

Pharmacokinetics of Paracetamol

Description

Area under the paracetamol concentration-time curve

Time Frame

Breakfast and dinner from 0 to 4 hours

Title

Glucose Pharmacodynamics

Description

Area under the sensor glucose concentration-time curve

Time Frame

Breakfast, lunch and dinner from 0 to 4 hours

Title

Glucagon Pharmacodynamics

Description

Area under the plasma glucagon concentration-time curve

Time Frame

Breakfast and dinner from 0 to 4 hours

Title

Hypoglycaemic episodes

Description

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

Time Frame

0 to 50 hours

Title

Gastrointestinal symptoms

Description

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

Time Frame

0 to 50 hours

Title

Local tolerability at pump injection site

Description

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

Time Frame

0 to 50 hours

Title

Incidence of adverse event

Description

Number of adverse events during the 0 to 50 hour period.

Time Frame

0 to 50 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexia Macina

Phone

+1 514-623-2520

alexia.macina@affiliate.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Tsoukas, MD

Organizational Affiliation

Applied Medical Informatics Research Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hygea Medical Clinic

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A3T2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louise Ullyatt

Phone

5149380995

louise@cmhygea.com

12. IPD Sharing Statement

Plan to Share IPD

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Safety and Efficacy of BC LisPram

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