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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Subcutaneous-delivery of insulin lispro using pump therapy.
Subcutaneous-delivery of BC LisPram using pump therapy.
Hygea Medical Clinic
Montreal, Quebec, Canada
RECRUITINGPharmacokinetics of Pramlintide
Area under the pramlintide concentration-time curve
Time frame: Breakfast, lunch, dinner from 0 to 4 hours
Pharmacokinetics of Insulin
Area under the insulin concentration-time curve
Time frame: Breakfast, lunch, dinner from 0 to 4 hours
Pharmacokinetics of Paracetamol
Area under the paracetamol concentration-time curve
Time frame: Breakfast and dinner from 0 to 4 hours
Glucose Pharmacodynamics
Area under the sensor glucose concentration-time curve
Time frame: Breakfast, lunch and dinner from 0 to 4 hours
Glucagon Pharmacodynamics
Area under the plasma glucagon concentration-time curve
Time frame: Breakfast and dinner from 0 to 4 hours
Hypoglycaemic episodes
Number of hypoglycaemic episodes during the 0 to 50 hour period.
Time frame: 0 to 50 hours
Gastrointestinal symptoms
Frequency of gastrointestinal symptoms during the 0 to 50 hour period.
Time frame: 0 to 50 hours
Local tolerability at pump injection site
Local tolerability at pump injection site during the 0 to 50 hour period.
Time frame: 0 to 50 hours
Incidence of adverse event
Number of adverse events during the 0 to 50 hour period.
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Time frame: 0 to 50 hours