Clinical trial NCT04972175: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type1 Diabetes Mellitus
Keywords: Pramlintide
Lead sponsor: Applied Medical Informatics Research Inc.
Sponsor class: NETWORK
Collaborators: name: Adocia
First posted: 2021-07-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Pharmacokinetics of Pramlintide
timeFrame: Breakfast, lunch, dinner from 0 to 4 hours
measure: Pharmacokinetics of Insulin
timeFrame: Breakfast, lunch, dinner from 0 to 4 hours
measure: Pharmacokinetics of Paracetamol
timeFrame: Breakfast and dinner from 0 to 4 hours
measure: Glucose Pharmacodynamics
timeFrame: Breakfast, lunch and dinner from 0 to 4 hours
measure: Glucagon Pharmacodynamics
timeFrame: Breakfast and dinner from 0 to 4 hours
measure: Hypoglycaemic episodes
timeFrame: 0 to 50 hours
measure: Gastrointestinal symptoms
timeFrame: 0 to 50 hours
measure: Local tolerability at pump injection site
timeFrame: 0 to 50 hours
measure: Incidence of adverse event
timeFrame: 0 to 50 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hygea Medical Clinic
state: Quebec
Study officials:
affiliation: Applied Medical Informatics Research Inc.
name: Michael Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
References: