Safety and Efficacy of BC LisPram

NCT04972175 | Unknown Phase 1

• 2 other identifiers: 2021-00050920Pro00050920
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Keywords

Pramlintide

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetics of Pramlintide

  Area under the pramlintide concentration-time curve

  Breakfast, lunch, dinner from 0 to 4 hours

• Pharmacokinetics of Insulin

  Area under the insulin concentration-time curve

  Breakfast, lunch, dinner from 0 to 4 hours

• Pharmacokinetics of Paracetamol

  Area under the paracetamol concentration-time curve

  Breakfast and dinner from 0 to 4 hours

• Glucose Pharmacodynamics

  Area under the sensor glucose concentration-time curve

  Breakfast, lunch and dinner from 0 to 4 hours

• Glucagon Pharmacodynamics

  Area under the plasma glucagon concentration-time curve

  Breakfast and dinner from 0 to 4 hours

• Hypoglycaemic episodes

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

  0 to 50 hours

• Gastrointestinal symptoms

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

  0 to 50 hours

• Local tolerability at pump injection site

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

  0 to 50 hours

• Incidence of adverse event

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

  0 to 50 hours

Study Arms (3)

Rapid Insulin lispro - Conventional bolus

ACTIVE COMPARATOR

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

Drug: 50-Hour Intervention - Rapid Insulin lispro

BC LisPram - Conventional bolus

EXPERIMENTAL

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

Drug: 50-Hour Intervention - BC LisPram

BC LisPram - Dual wave bolus

EXPERIMENTAL

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.

Drug: 50-Hour Intervention - BC LisPram

Interventions

50-Hour Intervention - Rapid Insulin lispro DRUG

Subcutaneous-delivery of insulin lispro using pump therapy.

Rapid Insulin lispro - Conventional bolus

50-Hour Intervention - BC LisPram DRUG

Subcutaneous-delivery of BC LisPram using pump therapy.

BC LisPram - Conventional bolus; BC LisPram - Dual wave bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Michael Tsoukas: lead
• Adocia: collaborator

Study Sites (1)

Hygea Medical Clinic

Montreal, Quebec, H4A3T2, Canada

RECRUITING

Study Officials

• Michael Tsoukas, MD

  Applied Medical Informatics Research Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexia Macina

CONTACT

+1 514-623-2520; alexia.macina@affiliate.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: July 28, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)