DRUG
50-Hour Intervention - Rapid Insulin lispro
Subcutaneous-delivery of insulin lispro using pump therapy.
Status
Unknown
Phase
Phase 1
Enrollment
16
Locations
1
Results
Not posted
Publications
0
Study 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.
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.
Interventions
DRUG
Subcutaneous-delivery of insulin lispro using pump therapy.
DRUG
Subcutaneous-delivery of BC LisPram using pump therapy.
Timeline
First posted
Jul 22, 2021
Study start
Jul 28, 2021
Primary completion
Jun 2022
Study completion
Jun 2022
Results posted
Not reported
Registry updated
Feb 16, 2022
Outcomes
Pharmacokinetics of Pramlintide
Time frame · Breakfast, lunch, dinner from 0 to 4 hours
Area under the pramlintide concentration-time curve
Pharmacokinetics of Insulin
Time frame · Breakfast, lunch, dinner from 0 to 4 hours
Area under the insulin concentration-time curve
Pharmacokinetics of Paracetamol
Time frame · Breakfast and dinner from 0 to 4 hours
Area under the paracetamol concentration-time curve
Glucose Pharmacodynamics
Time frame · Breakfast, lunch and dinner from 0 to 4 hours
Area under the sensor glucose concentration-time curve
Glucagon Pharmacodynamics
Time frame · Breakfast and dinner from 0 to 4 hours
Area under the plasma glucagon concentration-time curve
Hypoglycaemic episodes
Time frame · 0 to 50 hours
Number of hypoglycaemic episodes during the 0 to 50 hour period.
Gastrointestinal symptoms
Time frame · 0 to 50 hours
Frequency of gastrointestinal symptoms during the 0 to 50 hour period.
Local tolerability at pump injection site
Time frame · 0 to 50 hours
Local tolerability at pump injection site during the 0 to 50 hour period.
Not reported in the indexed record.
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.).
Study locations
Canada. Showing up to 24 locations stored in the fast local snapshot.
Hygea Medical Clinic
Montreal, Quebec, Canada
Publications
No PMID-linked publications were present in this registry snapshot.
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