Safety and Efficacy of BC LisPram

M

Michael Tsoukas

Status and phase

Enrolling
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

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

Trial contacts and locations

0

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Central trial contact

Alexia Macina

Data sourced from clinicaltrials.gov

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