Recruiting
Phase 1

BC LisPram

Sponsor:

Michael Tsoukas

Code:

NCT04972175

Conditions

Type1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

50-Hour Intervention - Rapid Insulin lispro

50-Hour Intervention - BC LisPram

Study Details

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

Study ID

NCT04972175

Start date

Jul 28, 2021

Status verified date

Feb, 2022

Completion date

Jun, 2022

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Rapid Insulin lispro - Conventional bolus

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

experimental: BC LisPram - Conventional bolus

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

experimental: 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.

Interventions

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.

Primary outcome measure

  • Pharmacokinetics of Pramlintide [ Time Frame: Breakfast, lunch, dinner from 0 to 4 hours ]
  • Pharmacokinetics of Insulin [ Time Frame: Breakfast, lunch, dinner from 0 to 4 hours ]
  • Pharmacokinetics of Paracetamol [ Time Frame: Breakfast and dinner from 0 to 4 hours ]
  • Glucose Pharmacodynamics [ Time Frame: Breakfast, lunch and dinner from 0 to 4 hours ]
  • Glucagon Pharmacodynamics [ Time Frame: Breakfast and dinner from 0 to 4 hours ]
  • Hypoglycaemic episodes [ Time Frame: 0 to 50 hours ]
  • Gastrointestinal symptoms [ Time Frame: 0 to 50 hours ]
  • Local tolerability at pump injection site [ Time Frame: 0 to 50 hours ]
  • Incidence of adverse event [ Time Frame: 0 to 50 hours ]

Central Contacts and Locations

Central contacts

Alexia Macina

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

Locations

Hygea Medical Clinic

Recruiting

Montreal, Quebec, Canada, H4A3T2

Contacts

Louise Ullyatt

5149380995louise@cmhygea.com

More Information

Sponsor

Michael Tsoukas

Last update posted

Feb 16, 2022

Last verified

Feb, 2022

Keywords

  • Pramlintide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael Tsoukas on 2022-02-16.