Safety and Efficacy of BC LisPram

Michael Tsoukas

Status and phase: Unknown; Phase 1

Conditions: Type1 Diabetes Mellitus

Treatments: Drug: 50-Hour Intervention - BC LisPram; Drug: 50-Hour Intervention - Rapid Insulin lispro

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04972175

2021-00050920

Pro00050920 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Rapid Insulin lispro - Conventional bolus

Active Comparator group

Description:

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

Treatment:

Drug: 50-Hour Intervention - Rapid Insulin lispro

BC LisPram - Conventional bolus

Experimental group

Description:

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

Treatment:

Drug: 50-Hour Intervention - BC LisPram

BC LisPram - Dual wave bolus

Experimental group

Description:

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.

Treatment:

Drug: 50-Hour Intervention - BC LisPram