Type1 Diabetes Mellitus
Conditions
Keywords
Pramlintide
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.
Interventions
DRUG50-Hour Intervention - Rapid Insulin lispro
Subcutaneous-delivery of insulin lispro using pump therapy.
DRUG50-Hour Intervention - BC LisPram
Subcutaneous-delivery of BC LisPram using pump therapy.
Sponsors
Adocia
Michael Tsoukas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Pramlintide | Breakfast, lunch, dinner from 0 to 4 hours | Area under the pramlintide concentration-time curve |
| Pharmacokinetics of Insulin | Breakfast, lunch, dinner from 0 to 4 hours | Area under the insulin concentration-time curve |
| Pharmacokinetics of Paracetamol | Breakfast and dinner from 0 to 4 hours | Area under the paracetamol concentration-time curve |
| Glucose Pharmacodynamics | Breakfast, lunch and dinner from 0 to 4 hours | Area under the sensor glucose concentration-time curve |
| Glucagon Pharmacodynamics | Breakfast and dinner from 0 to 4 hours | Area under the plasma glucagon concentration-time curve |
| Hypoglycaemic episodes | 0 to 50 hours | Number of hypoglycaemic episodes during the 0 to 50 hour period. |
| Gastrointestinal symptoms | 0 to 50 hours | Frequency of gastrointestinal symptoms during the 0 to 50 hour period. |
| Local tolerability at pump injection site | 0 to 50 hours | Local tolerability at pump injection site during the 0 to 50 hour period. |
| Incidence of adverse event | 0 to 50 hours | Number of adverse events during the 0 to 50 hour period. |
Countries
Canada
Contacts
Primary ContactAlexia Macina
Outcome results
None listed